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International Journal of Nursing Studies 49 (2012) 345–359
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eventing pressure ulcers—Are pressure-redistributing support
surfaces
fective? A Cochrane systematic review and meta-analysis§
zabeth McInnes a,*, Asmara Jammali-Blasi a, Sally Bell-Syer b,
Jo Dumville c, Nicky Cullum d
rsing Research Institute – St Vincents and Mater Health Sydney
& Australian Catholic University, National Centre for Clinical
Outcomes Research (NaCCOR),
l 5, Delacy Building, 379 Victoria St Darlinghurst, NSW 2010,
Australia
chrane Wounds Group, Department of Health Sciences,
University of York, Heslington, York YO10 5DD, UK
partment of Health Sciences, University of York, Heslington,
York YO10 5DD, UK
ool of Nursing, Midwifery and Social Work, University of
Manchester, Room 6.326, Jean McFarlane Building, Oxford
Road, Manchester M13 9PL, UK
What is already known about this topic?
� Pressure ulcers are areas of localised damage to the skin
and underlying tissue due to pressure, shear or friction.
� Pressure ulcers may affect those who are medically
compromised, obese, pregnant and the elderly.
T I C L E I N F O
le history:
ived 27 July 2011
ived in revised form 11 October 2011
pted 18 October 2011
ords:
sure ulcer
ention
ew
pital equipment
a-analysis
A B S T R A C T
Objectives: To undertake a systematic review of the
effectiveness of pressure redistributing
support surfaces in the prevention of pressure ulcers.
Design: Systematic review and meta-analysis.
Data sources: Cochrane Wound Group Specialised Register, The
Cochrane Central Register
of Controlled Trials, Ovid MEDLINE, Ovid EMBASE and
EBSCO CINAHL. The reference
sections of included trials were searched for further trials.
Review methods: Randomised controlled trials and quasi-
randomised trials, published or
unpublished, which assessed the effects of support surfaces in
preventing pressure ulcers
(of any grade), in any patient group, in any setting compared to
any other support surface,
were sought. Two reviewers extracted and summarised details
of eligible trials using a
standardised form and assessed the methodological quality of
each trial using the
Cochrane risk of bias tool.
Results: Fifty-three eligible trials were identified with a total of
16,285 study participants.
Overall the risk of bias in the included trials was high. Pooled
analysis showed that: (i)
foam alternatives to the standard hospital foam mattress reduce
the incidence of pressure
ulcers in people at risk (RR 0.40, 95% CI 0.21–0.74) and
Australian standard medical
sheepskins prevent pressure ulcers compared to standard care
(RR 0.48, 95% CI 0.31–0.74).
Pressure-redistributing overlays on the operating table
compared to standard care reduce
postoperative pressure ulcer incidence (RR 0.53, 95% CI 0.33–
0.85).
Conclusions: While there is good evidence that higher
specification foam mattresses,
sheepskins, and that some overlays in the operative setting are
effective in preventing
pressure ulcers, there is insufficient evidence to draw
conclusions on the value of seat
cushions, limb protectors and various constant low pressure
devices. The relative merits of
higher-tech constant low pressure and alternating pressure for
prevention are unclear.
More robust trials are required to address these research gaps.
� 2011 Elsevier Ltd. All rights reserved.
This review is an abridged version of a Cochrane Review
previously
lished in the Cochrane Database of Systematic Reviews 2011,
Issue 4,
10.1002/14651858.CD001735.
Corresponding author. Tel.: +61 02 8382 3793; fax: +61 02
8382 3792.
E-mail address: [email protected] (E. McInnes).
Contents lists available at SciVerse ScienceDirect
International Journal of Nursing Studies
journal homepage: www.elsevier.com/ijns
0-7489/$ – see front matter � 2011 Elsevier Ltd. All rights
reserved.
10.1016/j.ijnurstu.2011.10.014
http://dx.doi.org/10.1016/j.ijnurstu.2011.10.014
mailto:[email protected]
http://www.sciencedirect.com/science/journal/00207489
http://dx.doi.org/10.1016/j.ijnurstu.2011.10.014
E. McInnes et al. / International Journal of Nursing Studies 49
(2012) 345–359346
� Clinical and non-clinical settings use a variety of support
surfaces to prevent the occurrence of pressure ulcers.
What this paper adds
� Low-tech foam mattresses, sheepskins and operating
table overlays are able to prevent pressure ulcers.
� There is insufficient evidence to draw conclusions on the
value of seat cushions, limb protectors and various
constant low pressure devices.
� Future trials investigating the effectiveness of support
surfaces for preventing pressure ulcers should be
robustly designed, paying particular attention to report-
ing follow-up times; attrition rates, intention to treat
analysis, and giving adequate descriptions of interven-
tions, comparators and definitions of pressure ulcer
status.
1. Introduction
Rationale: Pressure ulcers (also known as pressure
sores, bed sores and decubitus ulcers) are chronic wounds
involving areas of localised damage to the skin and
underlying tissue, which are caused by pressure, or caused
by both pressure and shear (European Pressure Ulcer
Advisory Panel and National Pressure Ulcer Advisory Panel,
2009). Pressure ulcers may develop in those who are
seriously ill, neurologically compromised, or who have
impaired mobility (Allman, 1997; Berlowitz et al., 1997;
Bianchetti et al., 1993). Poor nutrition (Banks, 1998; Casey,
1998, 1997), obesity (Gallagher, 1997), poor posture and
age (Rinda and Falce, 2002; Spoelhof, 2000; Thomas, 2001)
have also been reported as increasing the risk of
developing pressure ulcers. Studies conducted in health-
care facilities in Europe, Canada and the USA, report
pressure ulcer prevalence ranges of 8–26% (Vanderwee
et al., 2007a; Woodbury and Houghton, 2004). In Australia
a national prevalence rate of 5–15% has been reported
(Australian Commission for Safety and Quality in Health
Care (ACSQHC), 2005). In Europe 58% of pressure ulcers
and 70% in the USA are classified as Grade 2 and above
(Vanderwee et al., 2007b; Van Gilder et al., 2009). A Grade
2 pressure ulcer involves partial thickness loss of the
dermis and a pressure ulcer classified as Grade 2 or greater
is a serious pressure injury requiring treatment (European
Pressure Ulcer Advisory Panel and National Pressure Ulcer
Advisory Panel, 2009). There is some evidence that
different grades of ulcer have different aetiologies and it
is suggested that Grade 2 ulcers are due to friction and
Grades 3 and 4 due to pressure and shearing forces
(Lahmann and Kottner, 2011).
Pressure ulcers are debilitating, painful and difficult to
heal (Girouard et al., 2008). They are also associated with
psychological, physical and social problems (Fox, 2002;
Franks et al., 2002; Langemo et al., 2000), and have a
detrimental impact on quality of life (Essex et al., 2009;
Gorecki et al., 2009). The costs of preventing and treating
pressure ulcers are high. Total annual costs for treating
pressure ulcers in the UK have been estimated at between
1.4 and 2.1 billion pounds (Phillips and Buttery, 2009) and
in the USA between 2.2 and 3.6 billion dollars (Van Gilder
et al., 2009). In Australia, the predicted number of bed days
lost due to pressure ulcers incurred a median opportunity
cost of AU$285 million (Graves et al., 2005a) and a median
excess length of stay of 4.31 days (Graves et al., 2005b).
The management of pressure ulcers is challenging for
clinicians (Fox, 2002; Franks et al., 2002; Langemo et al.,
2000) and pressure-redistributing support surfaces are
commonly used as a means of prevention. Pressure
redistributing support surfaces aim to reduce the magni-
tude and/or duration of pressure between an individual
and the support surface used (interface pressure) in order
to prevent or treat the pressure ulcer (European Pressure
Ulcer Advisory Panel and National Pressure Ulcer Advisory
Panel, 2009). Support surfaces include overlays, mat-
tresses, cushions, sheepskins and beds. These can be
classified either as ‘low tech’ devices, which are conform-
ing support surfaces that mould around the shape of the
patient to distribute the body weight over a large area and
include constant low-pressure devices such as foam
mattresses, or ‘high tech’ dynamic devices, such as
alternating support surfaces where inflatable cells alter-
nately inflate and deflate (McInnes et al., 2011). Some
support surfaces such as turning beds/frames are mechan-
ical and work by motor-driven turning and tilting.
There are many such support surfaces available and
prevention initiatives should be based on the best available
evidence of effectiveness. Hence we have undertaken a
systematic review of randomised controlled trials (RCTs)
with the aim of providing clinicians with information on
which to base decisions about choice of support surfaces
for the prevention of pressure ulcers.
Objective: To examine (1) which pressure-redistributing
cushions, beds, mattress overlays and mattress replace-
ments reduce the incidence of pressure ulcers compared
with standard support surfaces and (2) how effective
different pressure-redistributing surfaces are in preventing
pressure ulcers, when compared with one another.
2. Methods
Protocol and registration: The full Cochrane systematic
review on which this article is based can be accessed from
the Cochrane Database of Systematic Reviews (report
number CD001735) (McInnes et al., 2011). This report
adheres to the PRISMA method for reporting on systematic
reviews (Moher et al., 2009).
Eligibility criteria: RCTs and quasi-randomised trials
comparing beds, mattresses, mattress overlays and cush-
ions in any setting, on any clinical population, of any age,
with any condition, which measured the incidence of new
pressure ulcers. Trials which used only subjective mea-
sures of outcome (e.g. skin condition ‘‘better’’ or ‘‘worse’’)
were excluded, as were trials which reported only proxy
outcome measures such as interface pressure.
Search Strategy (including information sources): We
searched, without language, publication status or date
restriction, the Cochrane Wounds Group Specialised
Register (searched 8 December 2010); The Cochrane
Central Register of Controlled Trials (CENTRAL) (The
Cochrane Library Issue 4, 2010); Ovid MEDLINE (1950 to
November Week 3, 2010); Ovid MEDLINE In-Process and
Oth
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E. McInnes et al. / International Journal of Nursing Studies 49
(2012) 345–359 347
er Non-Indexed Citations (December 07, 2010); Ovid
BASE (1980–2010 Week 48) and EBSCO CINAHL (1982
3 December 2010). The Ovid MEDLINE search was
bined with the Cochrane Highly Sensitive Search
tegy for identifying randomised trials in MEDLINE:
sitivity- and precision-maximising version (2008 revi-
) (Lefebvre et al., 2009). The Ovid EMBASE and EBSCO
AHL searches were combined with the trial filters
eloped by the Scottish Intercollegiate Guidelines Net-
rk (SIGN) (Scottish Intercollegiate Guidelines Network,
9). The full electronic search strategy used in The
hrane Central Register of Controlled Trials (CENTRAL) is
sented in Box 1.
Prior to conducting the electronic searches, experts
re contacted to enquire about ongoing and recently
lished trials in the area of wound care. Citations within
ained reviews and relevant papers were scrutinised to
ntify additional trials.
Study selection: The titles and abstracts of the search
ults were independently assessed for eligibility and
vance by two authors and the full copies of all
entially relevant trials were obtained. Decisions on
l inclusion after full text assessment was made by one
hor and checked by a second; disagreements were
resolved by discussion with a third author. Rejected trials
were checked by a third author.
Data collection process (including data items): Details of
eligible trials were extracted by two review authors
independently and summarised using a data extraction
sheet. Disagreements were resolved by discussion with a
third author. Data extracted from each study included
patient characteristics, care setting, key baseline variables
(age, sex, baseline risk, baseline area of existing ulcers),
description of the interventions, number of patients
randomised to each intervention, description of any co-
interventions/standard care, follow-up period, outcomes
and acceptability/reliability of equipment if reported. If
data were missing from reports, attempts were made to
contact the study author to complete the information
necessary for the analysis and risk of bias assessment. If
trials were published more than once, they were maxi-
mally data extracted and a primary reference cited.
Risk of bias in individual trials: The methodological and
reporting quality of each trial was assessed by a single
author and checked by a second using a risk of bias
assessment tool which addressed the fulfilment criteria as
‘low risk of bias’, ‘high risk of bias’ or ‘unsure’ (Higgins et al.,
2009). This involved examining whether there was evidence
of true randomisation; allocation concealment; baseline
comparability of groups; blinded outcome assessment and
intention-to-treat analysis. Eligible trials were also assessed
for incomplete outcome data; drop-out rates and whether
the study was free of selective outcome reporting. Dis-
agreements were resolved by discussion with a third author.
Summary measures (including synthesis of results):
Analysis was conducted using RevMan software (Review
Manager (RevMan) Version 5.0, 2008). If appropriate data
were available from included trials, dichotomous variables
of new pressure ulcers developed are presented as risk
ratio (RR) with 95% confidence intervals (CIs). When
continuous outcome variables, such as change in pressure
ulcer size or time of pressure ulcer development, were
measured, they were summarised using the mean
difference (MD). Where possible, Grade 1 pressure ulcers
(that is, those which resulted in non-blanchable redness of
the skin) were separated from Grade 2 or higher pressure
ulcers (Grade 2 generally refers to partial thickness loss of
dermis and higher Grades 3 and 4, respectively, refer to full
thickness tissue loss and full thickness tissue loss with
exposed bone, tendon or muscle (EPUAP-NPUAP 2009)) in
order to report on important clinical outcomes. Of the trials
that included people with pre-existing pressure ulcers,
only the incidence of new pressure ulcers was reported.
Trials with similar patients, comparisons and outcomes
were considered for pooled analysis. When there was more
than one trial comparing similar devices using the same
outcome measure (though possibly differing lengths of
follow up), statistical heterogeneity was assessed using I2
and tested for by chi-squared test. A value of I2 greater than
50% indicated substantial heterogeneity and was consid-
ered significant where p < 0.10 (Higgins et al., 2003). In the
absence of significant statistical heterogeneity, trials with
similar comparisons were pooled using a fixed effect
model (Higgins et al., 2011). Where there was substantial
statistical heterogeneity we pooled the data using the
ox 1. Search strategy used in The Cochrane Central
egister of Controlled Trials (CENTRAL).
1 MeSH descriptor Beds explode all trees
2 mattress*
3 cushion*
4 ‘‘foam’’ or transfoam
5 overlay*
6 ‘‘pad’’ or ‘‘pads’’
7 ‘‘gel’’
8 pressure NEXT relie*
9 pressure NEXT reduc*
10 pressure NEXT alleviat*
11 ‘‘low pressure’’ NEAR/2 device*
12 ‘‘low pressure’’ NEAR/2 support
13 constant NEAR/2 pressure
14 ‘‘static air’’
15 alternat* NEXT pressure
16 air NEXT suspension*
17 air NEXT bag*
18 water NEXT suspension*
19 elevation NEAR/2 device*
20 clinifloat or maxifloat or vaperm or therarest or
sheepskin or hammock or ‘‘foot waffle’’ or silicore
or Pegasus or cairwave
21 (turn* or tilt*) NEXT (bed* or frame*)
22 kinetic NEXT (therapy or table*)
23 net NEXT bed*
24 ‘‘positioning’’ or ‘‘repositioning’’
25 (#1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8
OR #9 OR #10 OR #11 OR #12 OR #13 OR #14 OR #15
OR #16 OR #17 OR #18 OR #19 OR #20 OR #21 OR #22
OR #23 OR #24)
26 MeSH descriptor Pressure Ulcer explode all trees
27 pressure NEXT (ulcer* or sore*)
28 decubitus NEXT (ulcer or sore*)
29 (bed NEXT sore*) or bedsore*
30 (#26 OR #27 OR #28 OR #29)
31 (#25 AND #30)
E. McInnes et al. / International Journal of Nursing Studies 49
(2012) 345–359348
random-effects model (Higgins et al., 2011). For the
purpose of meta-analysis it was assumed that risk ratio
remained constant for different lengths of follow up, hence
we pooled trials which followed participants for different
lengths of time. Where pooling was inappropriate, the
results of the trials were reported narratively.
3. Results
Fifty-three eligible randomised trials were identified
with a total of 16,285 study participants. Fig. 1 shows the
study selection process. Of the 112 full-text articles
assessed for eligibility, 59 were excluded for a variety of
reasons as detailed in Fig. 1.
The trials were conducted in a variety of settings
including operating theatres, intensive care units, ortho-
paedic hospital units, accident and emergency units,
extended care facilities and nursing homes. Sample sizes
ranged from 12 to 1972 participants and the reported
follow-up periods for trials ranged from one day to
12 months. Similar timing of outcome assessment
between groups under investigation was reported in 34
trials and these ranged from daily to weekly.
The methodological quality of the included trials is
presented in Table 1. Use of a randomly generated allocation
sequence was evident in 24 trials (Bennett et al., 1998;
Cadue et al., 2008; Cooper et al., 1998; Economides et al.,
1995; Gentilello et al., 1988; Geyer et al., 2001; Gilcreast
et al., 2005; Kemp et al., 1993; Keogh and Dealey, 2001;
Lazzara and Buschmann, 1991; McGowan et al., 2000;
Mistiaen et al., 2009; Nixon et al., 2006, 1998; Price et al.,
1999; Russell and Lichtenstein, 2000; Russell et al., 2003;
Sanada et al., 2003; Santy et al., 1994; Schultz et al., 1999;
Summer et al., 1989; Tymec et al., 1997; Vanderwee et al.,
2005; Vyhlidal et al., 1997). Methods of randomisation used
included table of random numbers, automated phone
systems and computerised random number generators.
Adequate allocation concealment – defined as those
involved in enrolling participants not being able to foresee
allocation through the use of central allocation, including
telephone or web-based randomisation, or sequentially
numbered, opaque, sealed envelopes – was evident in 16
Recor ds identified throu gh database
searching
(n = 184)
Sc
re
en
in
g
In
cl
ud
ed
E
lig
ib
ili
ty
Id
en
ti
fi
ca
ti
on
Additional records ide ntifie d through
other sources
(n = 11)
Records afte r duplicates re mov ed
(n =19 5 )
Recor ds screened
(n = 19 5)
Reco rds ex clud ed
(n = 83)
Full-te xt article s as sessed
for eligibility
(n = 112)
Full-text articles excluded, wit h
reason s
(n = 59)
Literatur e revi ews (n=2)
Incomple te data (n=8)
Did not report clinical
outcome (n=20)
Not a trial (n=11)
Different intervention (n=9)
Other inc lusion criteria not
met (n=9 )
Total trials in review
(n = 53)
Fig. 1. PRISMA flow diagram of study selection.
tria
199
199
et a
Tay
Wh
rep
et a
Gra
Tab
Risk
St
An
Ar
Be
Ca
Ca
Co
Co
Co
Co
Co
Co
Da
Ec
Ew
Ex
Fe
Ge
Ge
Ge
Gi
Go
Gr
Gr
Gu
Ha
Ho
In
Jo
Ke
Ke
La
La
Lim
M
M
Ni
Ni
Pr
Ru
Ru
Sa
Sa
Sc
Sid
St
Su
Ta
Ta
Th
Ty
Va
Vy
W
E. McInnes et al. / International Journal of Nursing Studies 49
(2012) 345–359 349
ls (Cadue et al., 2008; Cobb et al., 1997; Cooper et al.,
8; Economides et al., 1995; Geyer et al., 2001; Gray et al.,
8; Jolley et al., 2004; Keogh and Dealey, 2001; Mistiaen
l., 2009; Nixon et al., 2006, 1998; Sanada et al., 2003;
lor, 1999; Theaker et al., 2005; Vanderwee et al., 2005;
itney et al., 1984). Blinding of outcome assessment was
orted in 10 trials (Cavicchioli and Carella, 2007; Conine
l., 1990, 1994; Feuchtinger et al., 2006; Geyer et al., 2001;
y et al., 1998; Nixon et al., 1998; Russell et al., 2000;
Schultz, 1998; Theaker et al., 2005). Twenty-five trials
adequately addressed incomplete outcome data, for exam-
ple, by either having balanced or no missing outcome data,
or having missing data that have been imputed using
appropriate methods (Aronovitch et al., 1999; Bennett et al.,
1998; Cadue et al., 2008; Cavicchioli and Carella, 2007; Cobb
et al., 1997; Conine et al., 1990, 1993, 1994; Cooper et al.,
1998; Gebhardt et al., 1996; Geyer et al., 2001; Gilcreast
et al., 2005; Laurent, 1997; Lim et al., 1988; McGowan et al.,
le 1
of bias of included trials.
udy Adequate
sequence
generation
Allocation
concealment
Blinding Incomplete
outcome data
addressed
Free of
selective
reporting
Groups
similar at
baseline
Timing of
outcome
assessment
similar in
all groups
dersen et al. (1982) Unclear Unclear Unclear Unclear Low risk
Low risk Low risk
onovitch et al. (1999) Unclear Unclear Unclear Low risk Low
risk Low risk Low risk
nnett et al. (1998) Low risk Unclear Unclear Low risk High risk
Low risk High risk
due et al. (2008) Low risk Low risk Unclear Low risk Unclear
Low risk Low risk
vicchioli and Carella (2007) Unclear Unclear Low risk Low risk
Low risk High risk Low risk
bb et al. (1997) Unclear Low risk Unclear Low risk Low risk
High risk High risk
llier (1996) Unclear Unclear High risk Unclear Low risk
Unclear High risk
nine et al. (1990) Unclear Unclear Low risk Low risk Unclear
Low risk Unclear
nine et al. (1993) Unclear Unclear Unclear Low risk Low risk
Low risk Low risk
nine et al. (1994) Unclear Unclear Low risk Low risk Low risk
Low risk Low risk
oper et al. (1998) Low risk Low risk Unclear Low risk Low risk
Low risk Low risk
echsel and Conine (1985) Unclear Unclear Unclear Unclear Low
risk Low risk Low risk
onomides et al. (1995) Low risk Low risk Unclear Unclear Low
risk Low risk Low risk
ing et al. (1964) Unclear Unclear Unclear Unclear Low risk
Unclear Low risk
ton-Smith et al. (1982) High risk Unclear Unclear Unclear High
risk Low risk High risk
uchtinger et al. (2006) Unclear Unclear Low risk Unclear Low
risk Low risk Low risk
bhardt et al. (1996) Unclear Unclear Unclear Low risk Unclear
Low risk Unclear
ntilello et al. (1988) Low risk Unclear Unclear Unclear Unclear
Low risk High risk
yer et al. (2001) Low risk Low risk Low risk Low risk Low risk
Low risk Low risk
lcreast et al. (2005) Low risk High risk High risk Low risk
Unclear Unclear Low risk
ldstone et al. (1982) Unclear Unclear Unclear High risk Low
risk Low risk Low risk
ay and Campbell (1994) Unclear Unclear Unclear Unclear
Unclear Unclear High risk
ay et al. (1998) Unclear Low risk Low risk Unclear Unclear
Unclear Low risk
nningberg et al. (2000) Unclear Unclear Unclear Unclear High
risk Low risk Unclear
mpton (1997) Unclear Unclear Unclear Unclear Unclear Unclear
Unclear
fman et al. (1994) Unclear Unclear High risk Unclear High risk
Low risk Low risk
man et al. (1993) Unclear Unclear Unclear High risk High risk
Low risk Low risk
lley et al. (2004) Unclear Low risk High risk High risk High
risk Unclear Low risk
mp et al. (1993) Low risk Unclear Unclear High risk High risk
Unclear Low risk
ogh and Dealey (2001) Low risk Low risk Unclear High risk
High risk Low risk Low risk
urent (1997) Unclear Unclear High risk Low risk Low risk Low
risk Low risk
zzara and Buschmann (1991) Low risk Unclear Unclear Unclear
Low risk Low risk Low risk
et al. (1988) Unclear Unclear Unclear Low risk Low risk Low
risk Low risk
cGowan et al. (2000) Low risk Unclear High risk Low risk Low
risk Low risk Low risk
istiaen et al. (2009) Low risk Low risk High risk Unclear
Unclear Low risk Low risk
xon et al. (1998) Low risk Low risk Low risk Low risk Low risk
High risk Low risk
xon et al. (2006) Low risk Low risk High risk Low risk Low
risk Low risk Low risk
ice et al. (1999) Low risk Unclear High risk Unclear Low risk
Low risk Low risk
ssell et al. (2000) Low risk Unclear Low risk Low risk Low risk
Low risk Low risk
ssell et al. (2003) Low risk Unclear High risk Low risk Low risk
Low risk Low risk
nada et al. (2003) Low risk Low risk Unclear High risk Low
risk Low risk Low risk
nty et al. (1994) Low risk Unclear Unclear Unclear Low risk
Low risk Low risk
hultz et al. (1999) Low risk High risk Low risk Low risk Low
risk Low risk Low risk
eranko et al. (1992) Unclear Unclear Unclear Unclear Low risk
Unclear Unclear
apleton (1986) Unclear Unclear Unclear Low risk Unclear Low
risk Unclear
mmer et al. (1989) Low risk Unclear Unclear Low risk Low risk
Unclear Unclear
kala et al. (1996) Unclear High risk Unclear Low risk Low risk
Low risk Unclear
ylor (1999) Unclear Low risk Unclear Unclear High risk Low
risk Unclear
eaker et al. (2005) Unclear Low risk Low risk Unclear Low risk
Low risk Unclear
mec et al. (1997) Low risk Unclear Unclear Unclear Low risk
Unclear Unclear
nderwee et al. (2005) Low risk Low risk Unclear Unclear
Unclear Low risk Unclear
hlidal et al. (1997) Low risk Unclear Unclear Low risk Low risk
High risk Unclear
hitney et al. (1984) Unclear Low risk Unclear Low risk Low
risk Unclear Low risk
E. McInnes et al. / International Journal of Nursing Studies 49
(2012) 345–359350
2000; Nixon et al., 2006, 1998; Russell and Lichtenstein,
2000; Russell et al., 2003; Schultz et al., 1999; Stapleton,
1986; Summer et al., 1989; Takala et al., 1996; Vyhlidal et al.,
1997; Whitney et al., 1984). Thirty-three trials were judged
to be free of selective outcome reporting (Andersen et al.,
1982; Aronovitch et al., 1999; Cavicchioli and Carella, 2007;
Cobb et al., 1997; Collier, 1996; Conine et al., 1993, 1994;
Cooper et al., 1998; Daechsel and Conine, 1985; Economides
et al., 1995; Ewing et al., 1964; Feuchtinger et al., 2006;
Geyer et al., 2001; Goldstone et al., 1982; Laurent, 1997;
Lazzara and Buschmann, 1991; Lim et al., 1988; McGowan
et al., 2000; Nixon et al., 2006, 1998; Price et al., 1999;
Russell and Lichtenstein, 2000; Russell et al., 2003; Sanada
et al., 2003; Santy et al., 1994; Schultz et al., 1999; Sideranko
et al., 1992; Summer et al., 1989; Takala et al., 1996; Taylor,
1999; Theaker et al., 2005; Tymec et al., 1997; Vyhlidal et al.,
1997; Whitney et al., 1984). Thirty-seven trials reported that
participant groups under investigation were similar regard-
ing prognostic factors (including age, sex, continence and/or
reasons for immobility) (Andersen et al., 1982; Aronovitch
et al., 1999; Bennett et al., 1998; Cadue et al., 2008; Conine
et al., 1990, 1993, 1994; Cooper et al., 1998; Daechsel and
Conine, 1985; Economides et al., 1995; Exton-Smith et al.,
1982; Feuchtinger et al., 2006; Gebhardt et al., 1996;
Gentilello et al., 1988; Geyer et al., 2001; Goldstone et al.,
1982; Gunningberg et al., 2000; Hofman et al., 1994; Inman
et al., 1993; Keogh and Dealey, 2001; Laurent, 1997; Lazzara
and Buschmann, 1991; Lim et al., 1988; McGowan et al.,
2000; Mistiaen et al., 2009; Nixon et al., 2006; Price et al.,
1999; Russell and Lichtenstein, 2000; Russell et al., 2003;
Sanada et al., 2003; Santy et al., 1994; Schultz et al., 1999;
Stapleton, 1986; Takala et al., 1996; Taylor, 1999; Theaker
et al., 2005; Vanderwee et al., 2005).
Thirteen trials included patients with pre-existing
pressure ulcers. Of these, seven included only those with
Grade 1 pressure ulcers (Cavicchioli and Carella, 2007;
Exton-Smith et al., 1982; Hofman et al., 1994; Keogh and
Dealey, 2001; Mistiaen et al., 2009; Nixon et al., 1998;
Vanderwee et al., 2005), three included Grades 1 and 2
(Bennett et al., 1998; Nixon et al., 2006; Santy et al., 1994),
and one study included only those that were Grade 4
(Economides et al., 1995). For two trials it was not clear
what grades of pressure ulcer were included (Feuchtinger
et al., 2006; Lazzara and Buschmann, 1991) and for 14
trials it was unclear or unstated whether pre-existing
pressure ulcers were included.
Trials were classified into those that evaluated ‘low-
tech’ devices, ‘high-tech’ devices and other types of
support surfaces. This classification system is commonly
used, for example in national clinical guidelines
(National Institute for Clinical Excellence, 2003).
Twenty-three trials evaluated low-tech constant low-
pressure support surfaces (foam body supports, sheep-
skin overlay, heel devices and mattresses). Twenty-one
trials evaluated high tech support surfaces (alternating
pressure redistribution devices, low-air-loss beds and
air fluidised beds). Other support surfaces included
kinetic turning tables (two trials), profiling beds (one
study), operating table overlays (six trials) and seat
cushions (four trials). Characteristics of the included
Tables 1 and 2, respectively. Table 3 shows the results of
analyses.
4. Comparisons: ‘low-tech’ constant low pressure
support surfaces
4.1. Comparisons between ‘low-tech’ constant low pressure
support surfaces and standard foam surfaces
Nine trials evaluated a standard foam hospital mat-
tress compared with a ‘low-tech’ constant low pressure
support surface, including: water-filled mattresses
(Andersen et al., 1982); alternative foam mattresses
(Collier, 1996; Gray and Campbell, 1994; Hofman et al.,
1994; Russell et al., 2003; Santy et al., 1994); bead beds
(Goldstone et al., 1982); visco-elastic mattresses (Gun-
ningberg et al., 2000) and other low-tech mattresses
(Takala et al., 1996).
The five trials (Collier, 1996; Gray and Campbell, 1994;
Hofman et al., 1994; Russell et al., 2003; Santy et al., 1994)
comparing foam alternatives with the standard hospital
mattress were pooled using a random effects model
(I2 = 77%, x2 13.24, df = 3, p = 0.004). This analysis yielded
a pooled risk ratio of 0.40 (95% CI 0.21–0.74) or a relative
reduction of pressure ulcer incidence of 60% (95% CI 26–
79%), favouring the use of the foam alternative support
surfaces. The high heterogeneity in standard hospital
mattresses amongst these trials led to a separate meta-
analysis of four UK-based trials (Collier, 1996; Gray and
Campbell, 1994; Russell et al., 2003; Santy et al., 1994) as
variation in the standard hospital mattress is likely to be
lower in the UK. This analysis showed a significant benefit
of alternative foam over standard foam being maintained
(RR 0.41, 95% CI 0.19–0.87). As heterogeneity in this pooled
group was high (I2 = 84%, x2 12.41, df = 2, p = 0.002), Russell
et al. (2003) was removed as it was an outlier. Hetero-
geneity was reduced (I2 = 39%) and the pooled results
maintained a significant effect in favour of the alternative
foam support over the standard support surface (RR 0.29,
95% CI 0.16–0.52).
The four remaining trials in this category evaluated a
range of products against the standard hospital mattresses.
The incidence and severity of pressure ulcers in patients
deemed at ‘high risk’ were reduced when patients were
placed on either a bead filled mattress (Goldstone et al.,
1982) (RR 0.32, 95% CI 0.14–0.76), a water-filled mattress
(Andersen et al., 1982) (RR 0.35, 95% CI 0.15–0.79) or a
constant low-pressure mattress (Takala et al., 1996) (RR
0.06, 95% 0–0.99). Gunningberg et al. (2000) did not find
any significant difference in pressure ulcer incidence for
those allocated to a visco-elastic foam trolley mattress (in
ED) and standard mattress (on the ward) (4/48, 8%)
compared with those assigned to a standard trolley
mattress (in ED) and standard mattress (on the ward)
(8/53, 15%) (p = 0.36).
4.2. Comparisons between alternative foam support surfaces
Three trials (Gray et al., 1998; Kemp et al., 1993;
Vyhlidal et al., 1997) compared different foam alternatives
trials and risk of bias assessment of the trials appear in
Table 2
Reported
follow-up
alternating air
ess (n = 155)
10 days
col (n = 35) vs. 30 days
8) Unclear
otation mattress 7 days
18) 6 months
6) vs. foot waffle Unclear
(n = 50) 10 days
s (n = 50) 10 days
upports (43) Unclear
isco-elastic foam
ttress (A&E) and
14 days or
until discharge
rd mattress 14 days
. standard care Mean: 7 days
(experimental
group), 7.9 days
(control group)
lid foam overlay 1 month
ss (n = 33) 6 months
eepskin overlay,
tandard hospital
devices as
Until discharge
or transfer
= 272) Unclear
attress and
and cushion
Median: 8–14
days (experimental
group), 9–17 days
(control group)
(n = 441) vs. NHS 14 days
air mattress Mean: 9.4 days
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Characteristics of included trials.
Study (year) Participants Grade 1 pressure
ulcers included
Intervention (sample size)
‘Low tech’ constant
low pressure support surfaces (n = 23)a
Andersen et al. (1982)b Patients from the acute setting at high
risk of pressure
ulcer development (Anderson Scale)
No Standard hospital mattress (n = 161) vs.
mattress (n = 166) vs. water filled mattr
Cadue et al. (2008) Patients from ICU, aged > 18 years.
Waterlow score > 10 Nod Foam body support with standard
proto
Standard protocol (n = 35)
Collier (1996) Patients from a general medical ward No
Comparison of 8 foam mattresses (n = 7
Cooper et al. (1998) Patients aged > 65 years from mixed
emergency and
orthopaedic trauma wards
Nod Dry flotation mattress (n = 49) vs. dry fl
(n = 51)
Ewing et al. (1964) Elderly patients confined to bed, with
reduced mobility as
a result of neurological disorders, fixed joints or
peripheral vascular disease
Unclear Sheepskin (n = 18) vs. No sheepskin (n =
Gilcreast et al. (2005) Participants from military tertiary
academic medical
centres, moderate-high risk of pressure ulcer
development
No Heel protector (n = 77) vs. egg crate (n = 8
(n = 76)
Gray and Campbell (1994) Patients from orthopaedic trauma,
vascular and medical
oncology units, with no breaks in the skin. Waterlow
score > 15
Nod Mattress (n = 50) vs. standard mattress
Gray et al. (1998) Patients admitted to a district general
hospital,
weight < 160 kg
Nod Foam mattress (n = 50) vs. foam mattres
Goldstone et al. (1982) Patients aged > 60 years with a femur
fracture Unclear Bead bed system (n = 32) vs. standard s
Gunningberg et al. (2000) c Patients aged > 65 years with a
suspected hip fracture,
admitted via A&E
Nod Visco-elastic foam mattress (A&E) and v
overlay (ward) (n = 48) vs. standard ma
standard overlay (ward) (n = 53)
Hofman et al. (1994) Patients with a fractures neck of femur.
Dutch consensus
risk scale score > 8
Yes Cubed foam mattress (n = 21) vs. standa
(n = 23)
Jolley et al. (2004) Patients aged > 18 years, low – moderate
risk of
developing a pressure ulcer
No Sheepskin mattress overlay (n = 270) vs
(n = 269)
Kemp et al. (1993) Patients aged > 65 from general medical,
acute geriatric,
long-term care wards. Braden score > 16
Nod Convoluted foam overlay (n = 45) vs. so
(39)
Lazzara and Buschmann (1991) Nursing home residents at risk
of pressure ulcer
development. Norton score > 15
Unclear Air-filled overlay (n = 33) vs. gel mattre
McGowan et al. (2000) Patients aged > 60 years from an
extended care facility, at
risk of developing a pressure ulcer, use of a
wheelchair � 3 h a day. Norton score � 14
Nod Standard hospital mattress and sheets, sh
heel and elbow protectors (n = 155) vs. s
mattress and sheets and other low-tech
required (n = 142)
Mistiaen et al. (2009) Patients from an aged care facility and
rehabilitation
centre
Yes Sheepskin (n = 271) vs. standard care (n
Russell et al. (2003) Patients from acute elderly, orthopaedic
and
rehabilitation units, aged > 60 years
Unclear Visco-polymer energy absorbing foam m
cushion (n = 562) vs. standard mattress
(n = 604)
Santy et al. (1994) Patients aged > 55 years with a hip fracture
or pressure
ulcers
Yes Comparison between 4 foam mattresses
standard mattress (n = 64)
Sideranko et al. (1992) b Patients from ICU > 48 h Nod
Alternating air overlay (n = 20) vs. Static
(n = 20) vs. Water mattress (n = 17)
Reported
follow-up
olyether foam pad
34)
Unclear
= 21) vs. standard 14 days
pillow (n = unclear) Unclear
ss replacement Range:
10 – 21 days
r – SSI/Hillrom] Range:
1–60 days
w-pressure setting
tinuous low-
– Hill Rom]
2 weeks
2) vs. Static air
= 61)
40 days
s. Silicore fibre 3 months
) vs. Silicore fibre 3 months
uidised bed (n = 6) 2 weeks
) vs. large cell ripple 2 weeks
ys/mattresses/beds)
pports (overlays/
Unclear
vs. Alternating 20 days
(maximum)
d ICU bed (n = 49) Mean: 17 days
) vs. Alternating 60 days
mattress (post-op)
ress (ICU) and
s. standard mattress
attress (post-op)
tress (ICU) and
ost-op) (n = 77)
Unclear
= 40) vs. alternating
0)
14 days
. Single layer air cell
mattress (n = 35)
Unclear
ressure
ernative alternating
ributing cushion
Until discharge
lternating pressure 2 weeks post-ICU
discharge
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2
Table 2 (Continued )
Study (year) Participants Grade 1 pressure
ulcers included
Intervention (sample size)
Stapleton (1986) b Female elderly patients with a fractured neck
of femur.
Norton score < 14.
Nod Large cell ripple overlay (n = 32) vs. p
(n = 34) vs. Silicore fibre overlay (n =
Takala et al. (1996) Patients from ICU with an expected length
of stay > 5 days Unclear Continuous low-pressure mattress (n
hospital foam mattress (n = 19)
Tymec et al. (1997) Patients from large hospital. Braden score <
16 Nod Foot waffle (n = unclear) vs. hospital
Vyhlidal et al. (1997) Newly admitted patients to a skilled
nursing facility with
an estimated stay � 10 days. Braden score < 18
Nod Foam overlay (n = 20) vs. fibre mattre
(n = 20)
‘High tech’ pressure support surfaces (n = 18)a
Bennett et al. (1998) Acute and long term incontinent patients.
In bed > 16 h a
day
Yes Low-air-loss hydrotherapy [Clensicai
(n = 42) vs. standard care (n = 56)
Cavicchioli and Carella (2007) Acute and long-term care
patients at risk of pressure
ulcers and an expected admission � 2 weeks. Braden
score < 17 or mobility or subscales < 3 respectively
Yes High-tech mattress on alternating lo
(n = 86) vs. high-tech mattress on con
pressure setting (n = 84) [both due 2
Cobb et al. (1997) Patients aged > 18 years from hospital wards
and ICU.
Expected length of stay 1–2 weeks.
Nod Low-air-loss bed [KinAir – KCI] (n = 6
mattress overlay [Waffle – EHOB] (n
Conine et al. (1990) Patients aged 18–55 years with evidence of
chronic
neurological disease
Nod Alternating pressure overlay(n = 72) v
overlay (n = 76)
Daechsel and Conine (1985) Patients from a long-term care
hospital with chronic
neurological conditions and considered at high risk of
pressure ulcers
Nod Alternating pressure mattress (n = 16
overlay (n = 16)
Economides et al. (1995) Patients with stage 4 pressure ulcers
requiring
myocutaneous flap closure
No Dry flotation mattress (n = 6) vs. air-fl
Exton-Smith et al. (1982) Newly admitted geriatric patients
with a fractured neck of
femur
Yes Alternating pressure mattress (n = 31
mattress (n = 31)
Gebhardt et al. (1996) ICU patients with an admission > 3 days.
Norton score < 1 Nod Alternating pressure supports (overla
(n = 23) vs. constant low pressure su
mattresses/beds) (n = 20)
Hampton (1997) No details provided Unclear Alternating
pressure mattress (n-36)
pressure mattress (n = 39)
Inman et al. (1993) Patients aged > 17 years, APACHE score >
15. ICU
stay > 3 days
Unclear Low-air-loss beds (n = 49) vs. standar
Nixon et al. (2006) Patients aged > 55 years with an expected
length of
hospital stay � 7 days. Braden score = 1–2
Yes Alternating pressure overlay (n = 990
pressure mattress (n = 982)
Laurent (1997) Patients aged > 15 years and admitted for major
cardiovascular surgery. Hospital stay � 5 days with an ICU
admission
Unclear Standard mattress (ICU) and standard
(n = 80) vs. Alternating pressure matt
standard mattress (post-op) (n = 80) v
(ICU) vs. Continuous low-pressure m
(n = 75) vs. Alternating-pressure mat
continuous low-pressure mattress (p
Price et al. (1999) Patients aged > 60 years with a fractured
neck of femur.
Medley score > 25
Unclear Low pressure mattress and cushion (n
pressure mattress and cushion (n = 4
Sanada et al. (2003) Patients from an acute care unit. Bed bound
and requiring
head elevations. Braden score � 16.
Nod Double layer air cell overlay (n = 37) vs
overlay (n = 36) vs. standard hospital
Taylor (1999) Patients aged > 16 years Nod Alternating
pressure mattress with p
redistributing cushion (n = 22) vs. alt
pressure system with pressure redist
(n = 22)
Theaker et al. (2005) Patients aged > 80 years from ICU. At
high risk of pressure
ulcer development
Nod Alternating pressure bed (n = 30) vs. a
mattress (n = 32)
Vanderwee et al. (2005) Patients aged > 18 years from surgical,
internal medicine Yes Alternating pressure mattress with air
cushion for sitting
and air cushion
Unclear
convoluted foam 8 days
e] (n = 112) vs. 7 days
m cushion 3 months
= 73) 3 months
ing mattress and
(n = 85) vs.
ng mattress
5 days
entional bed Unclear
tandard foam 12 months
(n = 50) Range:
5 – 10 days
d foam cushion 5 months
ard mattress 8 days
Conventional 7 days
vs. usual care 6 days
ntional bed with Unclear
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3
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3
or geriatric hospital wards. An expected hospital stay
of � 3 days. Braden score < 17.
(n = 222) vs. visco-elastic foam mattress
for sitting (n = 225)
Whitney et al. (1984) Patients from medical-surgical wards in
bed for � 20 h a
day
Unclear Alternating pressure mattress (n-25) vs.
bed (n = 26)
‘Other’ pressure support surfaces (n = 12)a
Aronovitch et al. (1999) Patients aged > 18 years, undergoing
surgery (>3 h)
under general anaesthesia
Nod Alternating pressure system [MicroPuls
conventional management (n = 105)
Conine et al. (1993) Patients aged > 60 years from an extended
care facility
and high risk of a pressure ulcer. Sitting in a wheelchair
for � 4 h/day
No Slab cushion (n = 144) vs. contoured foa
(n = 144)
Conine et al. (1994) Elderly patients in an extended care
hospital and at high
risk of pressure ulcers. Sitting in a wheelchair for � 4 h/
day. Norton score < 14.
Unclear Gel cushion (n = 68) vs. foam cushion (n
Feuchtinger et al. (2006) Patients aged > 18 years, scheduled
for cardiac surgery
with extracorporeal circulation
Unclear Operating table with water filled warm
thermoactive visco elastic foam overlay
operating table with water filled warmi
(n = 90)
Gentilello et al. (1988) Critically ill patients in a surgical ICU,
immobilised due to
head injury, spinal injuries or traction
Unclear Kinetic treatment table (n = 27) vs. conv
(n = 38)
Geyer et al. (2001) Patients aged > 65 years, in a wheelchair.
Tolerance of
sitting in a wheelchair � 6 h, weight > 250 lbs. Braden
score � 18
No Pressure reducing cushion (n = 15) vs. s
cushion (n = 17)
Keogh and Dealey (2001) Patients aged > 18 years, from
surgical and medical
wards. Waterlow score = 15–25
Yes Profiling bed (n = 50) vs. flat-based bed
Lim et al. (1988) Patients aged > 60 years from an extended
care facility.
Use of a wheelchair � 3 h/day. Norton score � 14
No Foam slab cushion (n = 26) vs. contoure
(n = 26)
Nixon et al. (1998) Patients aged > 55 years, admitted for major
general,
gynaecological or vascular surgery in supine or lithotomy
position
Yes Dry visco elastic pad (n = 222) vs. stand
(n = 224)
Russell et al. (2000) Patients aged > 18 years, undergoing
scheduled
cardiothoracic surgery under general anaesthesia
and � long
Nod Alternating pressure overlay (n = 98) vs.
care (n = 100)
Schultz et al. (1999) Patients aged > 18 years, admitted for
surgery � 2 h in
lithotomy position
Nod Experimental mattress overlay (n = 206)
(n = 207)
Summer et al. (1989) Patients from ICU with sepsis, pneumonia,
respiratory
failure, drug overdose, metabolic coma, stroke,
neuromuscular disease or ARDS
Unclear Kinetic treatment table (n = 43) vs. conve
2-hourly turning (n = 43)
a Does not include trials appearing under another subheading.
b Paper is also considered under ‘low-tech constant low
pressure support surfaces’.
c Paper is also considered under ‘other pressure support
surfaces’.
d Existing pressure ulcers part of exclusion criteria.
Table 3
Results of analyses – pressure ulcer incidence.
Comparison Number of trials (authors) Participants Risk ratio
(95% CI) p-Value*
‘Low tech’ constant low pressure support surfaces
Comparison between low-tech CLP and SFM supports
Bead bed system vs. Standard supports 1 (Goldstone et al.) 75
0.32 (0.14, 0.76) –
Water filled mattress vs. Standard hospital mattress 1 (Andersen
et al.) 316 0.35 (0.15, 0.79) –
Constant low pressure mattress vs. Standard support 1 (Takala
et al.) 40 0.06 (0 to 0.99) –
Pooled trials
Foam alternatives vs. Standard hospital mattress 5 (Collier,
Gray 94, Hofman,
Russell 03, Santy)
2016 0.40 (0.21, 0.74) p = 0.004
Foam alternatives vs. Standard hospital mattress
(UK trials only)
4 (Collier, Gray 94, Russell
03, Santy)
1980 0.41 (0.19, 0.87) p = 0.020
Foam alternatives vs. Standard hospital mattress
(Russell et al., 2002 excluded)
3 (Collier. Gray 94. Santy) 814 0.29 (0.16, 0.52) p < 0.0001
Comparisons between AFM supports
Standard mattress vs. 4 foam mattresses 1 (Santy et al.) 505
0.36 (0.22, 0.59) –
Fibre mattress replace vs. foam overlay 1 (Vyhlidal et al.) 40
0.42 (0.18, 0.96) –
Convoluted foam overlay vs. Solid foam overlay 1 (Kemp et al.)
84 0.66 (0.37, 1.16) –
Foam body support (+standard protocol)
vs. Standard protocol
1 (Cadue et al.) 70 0.16 (0.05, 0.49) –
Comparison between dry flotation mattresses 1 (Cooper et al.)
84 0.63 (0.16, 2.47) –
Air filled overlay vs. Gel mattress 1 (Lazzara) 66 0.80 (0.24,
2.72) –
Pooled trials:
Comparison between sheepskins (all pressure
ulcer grades)
3 (Jolley, McGowan, Mistaein) 1281 0.48 (0.31, 0.74) p =
0.0008
Comparison between sheepskins (pressure ulcers
Grade 2 and above)
3 (Jolley, McGowan, Mistaein) 1281 Fixed effect: p = 0.04
0.56 (0.32, 0.97)
Random effect: p = 0.09
0.60 (0.34, 1.08)
‘High tech’ pressure support surfaces
AP: Comparison between AP and SFM supports
Pooled trials:
Alternating air-mattress vs. Overlay 2 (Andersen, Sanada) 409
0.31 (0.17, 0.58) p = 0.0002
AP: Comparison between AP and CLP supports
Pooled trials:
Silicore vs. foam overlays 4 (Conine 90, Daeschel, Stapleton,
Whitney)
31 0.91 (0.72, 1.16) p = 0.46
Alternating pressure device vs. static water/
air mattresses
3 (Andersen, Sideranko, Price) 458 1.31 (0.51, 3.35) p = 0.57
Alternating pressure devices vs. constant
low-pressure support
10 (Andersen, Cavicchioli, Conine 90,
Daeschel, Gebhardt, Price, Sideranko,
Stapleton, Vanderwee, Whitney)
1606 0.85 (0.64, 1.13) p = 0.28
LAL beds
Alternating pressure device vs. static water/
air mattresses
1 (Bennett et al.) 98 2.67 (0.86, 8.27) –
Pooled trials:
Comparison between LAL beds 2 (Inman, Cobb) 221 0.33 (0.16,
0.67) p = 0.002
Air-fluidised beds
Air fluidised bed vs. dry flotation mattress 1 (Economides et
al.) 12 1.00 (0.20, 4.95) –
Other pressure supports
Kinetic turning tables
Pooled trials:
Comparison between kinetic turning table
and conventional bed
2 (Gentillelo, Summer) 151 1.23 (0.57, 2.65) p = 0.59
Operating table overlays
Water filled warming mattress and overlay vs.
water filled warming mattress
1 (Feuchtinger et al.) 175 1.53 (0.69, 3.39) –
Dry visco-elastic pad vs. standard mattress 1 (Nixon et al., 98)
65 0.53 (0.33, 0.85) –
Pooled trials:
Alternating pressure system intraoperatively
vs. conventional care
2 (Aronovitch, Russell 00) 368 0.21 (0.06, 0.70) p = 0.01
Seat cushions
Slab cushion vs. contoured foam cushion 1 (Conine et al., 93)
248 1.00 (0.84, 1.18) –
E. McInnes et al. / International Journal of Nursing Studies 49
(2012) 345–359354
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are reported as individual results below as the
luated interventions are heterogeneous.
Vyhlidal et al. (1997) found a significant reduction in
ssure ulcer incidence in people randomised to a fibre
ttress replacement when compared with a foam overlay
0.42, 95% CI 0.18–0.96). No significant differences in
ssure ulcer incidence rates were found when compar-
a convoluted foam overlay and a solid foam overlay (RR
6, 95% CI 0.37–1.16) (Kemp et al., 1993) or in
parison of two foam mattresses, Transfoam (one
de 4 ulcer) and Transfoamwave (one Grade 2 ulcer)
ay et al., 1998).
Other ‘low-tech’ support surfaces with various
parisons
Three trials evaluating the use of sheepskins compared
tandard care were pooled (Jolley et al., 2004; McGowan
l., 2000; Mistiaen et al., 2009). A random effects model
s used as heterogeneity was substantial (I2 = 52%, x2
0, df = 2, p = 0.12). There were significantly fewer
ssure ulcers of any grade amongst those allocated to
epskins (RR 0.48, 95% CI 0.31–0.74). Across the three
ls, out of 1281 participants, 51 ulcers were Grade 2 and
her (3 participants developed an ulcer of Grades 3 or 4)
most ulcers were Grade 1. An analysis examining
de 2 and higher pressure ulcers yielded significant
ults (RR 0.56, 95% CI 0.32–0.97) using a fixed effects
lysis as (I2 = 3%, x2 2.06, df = 2, p = 0.36). However, a
dom effects analysis was also undertaken due to the
thodological heterogeneity (in terms of the participants
quality of the trials), and this was not significant (RR
0, 95% CI 0.34–1.08).
A significant reduction in pressure ulcer incidence
s found in a study comparing a foam body support
h a standard care protocol which included a water
ttress, half seated position and massages (RR 0.16,
CI 0.05–0.49) (Cadue et al., 2008). A comparison of a
l support surface (foot waffle) with elevation of heels
ng a hospital pillow, reported the incidence of
ssure ulcers in the foot waffle group (n = 6) to be
le that of the comparison group (n = 2) (study group
bers were not specified) (Tymec et al., 1997).
ther evaluation of a foot waffle (5/76), egg crate
87) and bunny boot (3/77) showed no differences,
ever, it was not clear whether the results related to
number of ulcers or the number of people with
ers (Gilcreast et al., 2005).
Comparisons of two dry flotation mattresses (Cooper
l., 1998); a gel mattress and an air filled overlay (Lazzara
Buschmann, 1991); alternating air overlay, static air
ttress and a water mattress (Sideranko et al., 1992)
and a large cell ripple mattress, polyether foam bed and
a Spenco pad (Stapleton, 1986), found no significant
differences.
5. Comparisons: ‘high-tech’ pressure support surfaces
5.1. Comparisons between alternating pressure supports and
standard hospital mattress
Two trials which compared alternative pressure sup-
ports compared with a standard hospital mattress
(Andersen et al., 1982; Sanada et al., 2003) were pooled
using a fixed effect model (I2 = 0%, x2 0.02, df = 1,
p = 0.0002). There was a significant reduction in pressure
ulcer development favouring the alternating pressure
surface (RR 0.31, 95% CI 0.17–0.58).
5.2. Comparisons between alternating pressure supports and
constant low pressure supports
No significant differences were found between Silicore
or foam overlays and alternating pressure devices when
pooling four studies (RR 0.91; 95% CI 0.72–1.16) (Conine
et al., 1990; Daechsel and Conine, 1985; Stapleton, 1986;
Whitney et al., 1984). Nor were significant differences
found in a pooled analysis comparing alternating pressure
devices and static water or static air mattresses (Andersen
et al., 1982; Price et al., 1999; Sideranko et al., 1992) (RR
1.31, 95% CI 0.51–3.35).
A pooled random effects analysis of 10 RCT’s comparing
various constant low-pressure devices and alternating-
pressure devices (Andersen et al., 1982; Cavicchioli and
Carella, 2007; Conine et al., 1990; Daechsel and Conine,
1985; Gebhardt et al., 1996; Price et al., 1999; Sideranko
et al., 1992; Stapleton, 1986; Vanderwee et al., 2005;
Whitney et al., 1984) found no significant difference
between the devices (RR 0.85; 95% CI 0.64–1.13).
A comparison of various combinations of standard,
constant low-pressure and alternating pressure mattresses
showed no significant benefits of using alternating
pressure in surgical intensive care patients intra- and
post-ICU (Laurent, 1997).
5.3. Comparisons between different alternating pressure
devices
A two-layer large cell ripple alternating pressure device
was found to be significantly more effective in preventing
pressure ulcers compared with another alternating-pres-
sure device (16% vs. 34%, p > 0.05) (Exton-Smith et al.,
1982). No other significant differences were observed in
any of the other four trials in this group.
le 3 (Continued )
mparison Number of trials (authors) Participants Risk ratio
(95% CI) p-Value*
1 (Lim et al.) 52 1.06 (0.75, 1.49) –
at cushion vs. standard cushion 1 (Geyer et al.) 32 0.68 (0.33,
1.42) –
y cushion vs. foam cushion 1 (Conine et al., 94) 141 0.61 (0.37,
1.00) –
p-values only reported for pooled analyses.
E. McInnes et al. / International Journal of Nursing Studies 49
(2012) 345–359356
5.4. Low-air-loss and air-fluidised beds
Three trials evaluated the use of low-air-loss beds in
preventing pressure ulcers (Bennett et al., 1998; Cobb
et al., 1997; Inman et al., 1993). Of these, two that
compared low-air-loss beds with a bed and overlay were
pooled using random effects (I2 = 26%) (Cobb et al., 1997;
Inman et al., 1993). A significant difference in favour of the
low-air-loss beds was found (RR 0.33, 95% CI 0.16–0.67).
The comparison between low-air-loss hydrotherapy and
standard care (Bennett et al., 1998) found that there was a
higher pressure ulcer incidence amongst those study
participants cared for on a the low-air-loss hydro support
surface (19%) compared to those who received standard
care (7%) (RR 2.67, 95% CI 0.86–8.27). No significant
differences were found between an air-fluidised bed and a
dry flotation mattress (Economides et al., 1995).
6. Comparisons between other pressure supports
6.1. Operating table overlays
Two trials compared the Micropulse system with a gel
pad during surgery and a standard mattress post-
operatively (Aronovitch et al., 1999, Russell and Lichten-
stein, 2000). These two trials were pooled (fixed effect
model I2 = 0%, x2 0.40, df = 1, p = 0.01) and the Micropulse
system was found to be significantly better at preventing
pressure ulcers (RR 0.21, 95% CI 0.06–0.70).
There was a significant reduction in the incidence of
post-operative pressure ulcers in participants allocated a
dry visco-elastic pad compared to standard care (RR 0.53,
95% CI 0.33–0.85) (Nixon et al., 1998). Schultz et al. (1999)
reported a higher incidence of pressure ulcers in patients in
the overlay group (26.6%) compared with 16.4% in the
standard care group (16.4%). More details about this study
was sought from the author but were not forthcoming.
The study by Feuchtinger et al. (2006) was terminated
because more people in the thermoactive viscoelastic foam
overlay group developed pressure ulcers (2 compared to
one in the group allocated a water-filled warming mattress
without the overlay).
6.2. Kinetic turning tables and profiling beds
Using a fixed effect model (I2 = 0%, x2 0.35, df = 1,
p = 0.59), there was no evidence of a significant difference
between kinetic turning tables compared with conven-
tional beds (Gentilello et al., 1988, Summer et al., 1989) (RR
1.23, 95% CI 0.57–2.65). Keogh et al. reported that no
pressure ulcers occurred in those cared for on a profiling
bed or on a flat-based bed.
6.3. Seat cushions
Four trials (Conine et al., 1993, 1994; Geyer et al., 2001;
Lim et al., 1988) evaluated the use of seat cushions. No
significant differences were found in the two trials that
compared slab and contoured foam cushions (Conine et al.,
1993; Lim et al., 1988) (RR 1.00, 95% CI 0.84–1.18) and (RR
1.06, 95% 0.75–1.49). Nor were differences found between
a pressure redistribution seat cushion compared with a
standard cushion (Geyer et al., 2001: RR 0.68, 95% CI 0.33–
1.42) or between a Jay cushion and foam cushion (Conine
et al., 1994: RR 0.61, 95% CI 0.37–1.00).
7. Discussion
This systematic review shows that a range of foam-
based, low pressure mattresses and overlays, sheepskins,
and also some ‘higher-tech’ support surfaces are more
effective than either standard hospital mattresses or
standard care in preventing pressure ulcers. In terms of
operating theatre support surfaces, Nixon et al. (1998)
found a gel-filled overlay to be significantly better than a
standard operating table. However, in two other trials a
gel-filled overlay on the operating table was less effective
than an alternating pressure overlay (the Micropulse
system) intra- and post-operatively (Aronovitch et al.,
1999; Russell and Lichtenstein, 2000). However in these
two trials it is not clear whether this is the result of better
postoperative pressure relief. Two other trials (Feuchtinger
et al., 2006; Schultz et al., 1999) reported post-operative
skin changes as a result of different operating theatre
overlays. However, the clinical importance of these results
is difficult to ascertain in the absence of details from the
authors such as pressure ulcer grading and comprehensive
descriptions of products evaluated. In addition, it is
difficult to separate out the role of postoperative care
and concomitant interventions; either of which may have
caused the skin changes (mainly found on buttock and
coccyx).
There are indications that two other interventions may
also be harmful. Firstly, Foot Waffle heel elevators were
associated with a non-significant trebling in the incidence
of pressure ulcers in a small trial (Tymec et al., 1997). In
another small trial over double the number of those cared
for on a low-air-loss hydro support surface developed
pressure ulcers compared to those allocated standard care
(Bennett et al., 1998). However, neither of these trials
provided clear information to indicate that the groups
were similar at baseline in relation to the most important
prognostic factors.
Despite the number of comparisons and different
products evaluated there remain gaps in the knowledge
base for which a rational research agenda could be
developed. For example, air fluidised therapy as a
prevention strategy has only been compared with dry
flotation, and low-air-loss only with standard care. The
results of meta-analyses of trials of sheepskins are
sensitive to the outcome measure selected. When analysis
is confined to Grade 2 and higher pressure ulcers, any
significant reduction in pressure ulcer incidence associated
with sheepskin disappears. The results reported in the
three studies are based predominantly on Grades 1 and 2
pressure ulcers, so the effects of sheepskins on preventing
more severe ulcers is uncertain. The estimates obtained
when analysing only Grade 2 and higher pressure ulcers
varied whether using a fixed effects (results significant) or
random effects (results not significant) model. While there
is some evidence that sheepskin reduced overall ulceration
incidence, once we sample the evidence using Grade 2 and
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E. McInnes et al. / International Journal of Nursing Studies 49
(2012) 345–359 357
her pressure ulcers, the power is reduced and the
erogeneity means that we cannot be fully confident of
results. It can be postulated that the likely mode of
ion of sheepskin will reduce friction but not pressure
therefore would be likely to impact on the incidence of
de 2 ulcers but not on more severe pressure damage.
ther evaluations are therefore required of medical
epskins of sufficient power to identify an effect on
de 2 ulcer incidence versus Grade 3 and higher.
Strengths and limitations
Generally, the risk of bias in the included trials was
h. While recent trials have improved reporting of some
dy details, common methodological flaws included lack
llocation concealment, lack of baseline comparability,
h attrition rates, lack of intention to treat analysis, lack
blind or independently verified outcome assessment.
s than half of the trials included sample size estimates
small sample size was a limitation in many.
Other flaws include failure to report on pressure ulcer
us on study entry. In many trials the definitions of
ssure ulcer free’, ‘low-risk’, ‘moderate-risk’ and ‘high-
’ varied widely and in some trials we were unable to
ertain whether study participants with Grade 1 ulcers
re accepted into the sample and included in the
lyses. ‘Standard care’ was poorly described in many
ls and clear descriptions of interventions were also
n lacking. Many of the trials reviewed did not provide
rmation about co-interventions, such as repositioning,
whether these were provided equally to each study
.
In terms of publication bias, it is important to note that
ny of the published trials identified had received some
ding from manufacturers. It is also important for the
der to be aware that in the older trials the materials
d in the production of support surfaces may no longer
used.
The strengths of our systematic review are the rigorous
rching and sifting methods, double data extraction and
ble assessment of risk of bias using a standardised tool
that we made attempts to contact study authors to
ain additional information when needed. Our findings
also consistent with a systematic review of RCT’s and
si-randomised trials investigating the prevention of
l pressure ulcers (Junkin and Gray, 2009) a systematic
iew on general pressure ulcer prevention (Reddy et al.,
6) and a review of three trials investigating the
ctiveness of Australian Medical Sheepskins (Mistiaen
l., 2010).
onclusion
A range of products such as low pressure mattresses
overlays, sheepskins, and some ‘higher-tech’ support
faces are effective at preventing pressure ulcers.
ever, the relative merits of some interventions such
higher-tech constant low pressure and alternating
ssure remain unclear. The use of seat cushions has not
n adequately evaluated and the findings of some trials
trials should address the deficiencies discussed above
while adhering to the CONSORT statement and also collect
data on aspects of equipment performance such as
reliability.
Conflict of interest
None declared.
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RePrefElia NuLeveb Coc Ded SchIntern.docx

  • 1. Re Pr ef Eli a Nu Leve b Co c De d Sch International Journal of Nursing Studies 49 (2012) 345–359 A R Artic Rece Rece Acce Keyw Pres Prev Revi
  • 2. Hos Met § pub doi: * 002 doi: view eventing pressure ulcers—Are pressure-redistributing support surfaces fective? A Cochrane systematic review and meta-analysis§ zabeth McInnes a,*, Asmara Jammali-Blasi a, Sally Bell-Syer b, Jo Dumville c, Nicky Cullum d rsing Research Institute – St Vincents and Mater Health Sydney & Australian Catholic University, National Centre for Clinical Outcomes Research (NaCCOR), l 5, Delacy Building, 379 Victoria St Darlinghurst, NSW 2010, Australia chrane Wounds Group, Department of Health Sciences, University of York, Heslington, York YO10 5DD, UK partment of Health Sciences, University of York, Heslington, York YO10 5DD, UK
  • 3. ool of Nursing, Midwifery and Social Work, University of Manchester, Room 6.326, Jean McFarlane Building, Oxford Road, Manchester M13 9PL, UK What is already known about this topic? � Pressure ulcers are areas of localised damage to the skin and underlying tissue due to pressure, shear or friction. � Pressure ulcers may affect those who are medically compromised, obese, pregnant and the elderly. T I C L E I N F O le history: ived 27 July 2011 ived in revised form 11 October 2011 pted 18 October 2011 ords: sure ulcer ention ew pital equipment a-analysis A B S T R A C T
  • 4. Objectives: To undertake a systematic review of the effectiveness of pressure redistributing support surfaces in the prevention of pressure ulcers. Design: Systematic review and meta-analysis. Data sources: Cochrane Wound Group Specialised Register, The Cochrane Central Register of Controlled Trials, Ovid MEDLINE, Ovid EMBASE and EBSCO CINAHL. The reference sections of included trials were searched for further trials. Review methods: Randomised controlled trials and quasi- randomised trials, published or unpublished, which assessed the effects of support surfaces in preventing pressure ulcers (of any grade), in any patient group, in any setting compared to any other support surface, were sought. Two reviewers extracted and summarised details of eligible trials using a standardised form and assessed the methodological quality of each trial using the Cochrane risk of bias tool. Results: Fifty-three eligible trials were identified with a total of 16,285 study participants.
  • 5. Overall the risk of bias in the included trials was high. Pooled analysis showed that: (i) foam alternatives to the standard hospital foam mattress reduce the incidence of pressure ulcers in people at risk (RR 0.40, 95% CI 0.21–0.74) and Australian standard medical sheepskins prevent pressure ulcers compared to standard care (RR 0.48, 95% CI 0.31–0.74). Pressure-redistributing overlays on the operating table compared to standard care reduce postoperative pressure ulcer incidence (RR 0.53, 95% CI 0.33– 0.85). Conclusions: While there is good evidence that higher specification foam mattresses, sheepskins, and that some overlays in the operative setting are effective in preventing pressure ulcers, there is insufficient evidence to draw conclusions on the value of seat cushions, limb protectors and various constant low pressure devices. The relative merits of higher-tech constant low pressure and alternating pressure for prevention are unclear. More robust trials are required to address these research gaps. � 2011 Elsevier Ltd. All rights reserved.
  • 6. This review is an abridged version of a Cochrane Review previously lished in the Cochrane Database of Systematic Reviews 2011, Issue 4, 10.1002/14651858.CD001735. Corresponding author. Tel.: +61 02 8382 3793; fax: +61 02 8382 3792. E-mail address: [email protected] (E. McInnes). Contents lists available at SciVerse ScienceDirect International Journal of Nursing Studies journal homepage: www.elsevier.com/ijns 0-7489/$ – see front matter � 2011 Elsevier Ltd. All rights reserved. 10.1016/j.ijnurstu.2011.10.014 http://dx.doi.org/10.1016/j.ijnurstu.2011.10.014 mailto:[email protected] http://www.sciencedirect.com/science/journal/00207489 http://dx.doi.org/10.1016/j.ijnurstu.2011.10.014 E. McInnes et al. / International Journal of Nursing Studies 49 (2012) 345–359346 � Clinical and non-clinical settings use a variety of support surfaces to prevent the occurrence of pressure ulcers. What this paper adds � Low-tech foam mattresses, sheepskins and operating
  • 7. table overlays are able to prevent pressure ulcers. � There is insufficient evidence to draw conclusions on the value of seat cushions, limb protectors and various constant low pressure devices. � Future trials investigating the effectiveness of support surfaces for preventing pressure ulcers should be robustly designed, paying particular attention to report- ing follow-up times; attrition rates, intention to treat analysis, and giving adequate descriptions of interven- tions, comparators and definitions of pressure ulcer status. 1. Introduction Rationale: Pressure ulcers (also known as pressure sores, bed sores and decubitus ulcers) are chronic wounds involving areas of localised damage to the skin and underlying tissue, which are caused by pressure, or caused by both pressure and shear (European Pressure Ulcer Advisory Panel and National Pressure Ulcer Advisory Panel, 2009). Pressure ulcers may develop in those who are seriously ill, neurologically compromised, or who have impaired mobility (Allman, 1997; Berlowitz et al., 1997; Bianchetti et al., 1993). Poor nutrition (Banks, 1998; Casey, 1998, 1997), obesity (Gallagher, 1997), poor posture and age (Rinda and Falce, 2002; Spoelhof, 2000; Thomas, 2001) have also been reported as increasing the risk of developing pressure ulcers. Studies conducted in health- care facilities in Europe, Canada and the USA, report pressure ulcer prevalence ranges of 8–26% (Vanderwee et al., 2007a; Woodbury and Houghton, 2004). In Australia a national prevalence rate of 5–15% has been reported (Australian Commission for Safety and Quality in Health Care (ACSQHC), 2005). In Europe 58% of pressure ulcers
  • 8. and 70% in the USA are classified as Grade 2 and above (Vanderwee et al., 2007b; Van Gilder et al., 2009). A Grade 2 pressure ulcer involves partial thickness loss of the dermis and a pressure ulcer classified as Grade 2 or greater is a serious pressure injury requiring treatment (European Pressure Ulcer Advisory Panel and National Pressure Ulcer Advisory Panel, 2009). There is some evidence that different grades of ulcer have different aetiologies and it is suggested that Grade 2 ulcers are due to friction and Grades 3 and 4 due to pressure and shearing forces (Lahmann and Kottner, 2011). Pressure ulcers are debilitating, painful and difficult to heal (Girouard et al., 2008). They are also associated with psychological, physical and social problems (Fox, 2002; Franks et al., 2002; Langemo et al., 2000), and have a detrimental impact on quality of life (Essex et al., 2009; Gorecki et al., 2009). The costs of preventing and treating pressure ulcers are high. Total annual costs for treating pressure ulcers in the UK have been estimated at between 1.4 and 2.1 billion pounds (Phillips and Buttery, 2009) and in the USA between 2.2 and 3.6 billion dollars (Van Gilder et al., 2009). In Australia, the predicted number of bed days lost due to pressure ulcers incurred a median opportunity cost of AU$285 million (Graves et al., 2005a) and a median excess length of stay of 4.31 days (Graves et al., 2005b). The management of pressure ulcers is challenging for clinicians (Fox, 2002; Franks et al., 2002; Langemo et al., 2000) and pressure-redistributing support surfaces are commonly used as a means of prevention. Pressure redistributing support surfaces aim to reduce the magni- tude and/or duration of pressure between an individual and the support surface used (interface pressure) in order to prevent or treat the pressure ulcer (European Pressure
  • 9. Ulcer Advisory Panel and National Pressure Ulcer Advisory Panel, 2009). Support surfaces include overlays, mat- tresses, cushions, sheepskins and beds. These can be classified either as ‘low tech’ devices, which are conform- ing support surfaces that mould around the shape of the patient to distribute the body weight over a large area and include constant low-pressure devices such as foam mattresses, or ‘high tech’ dynamic devices, such as alternating support surfaces where inflatable cells alter- nately inflate and deflate (McInnes et al., 2011). Some support surfaces such as turning beds/frames are mechan- ical and work by motor-driven turning and tilting. There are many such support surfaces available and prevention initiatives should be based on the best available evidence of effectiveness. Hence we have undertaken a systematic review of randomised controlled trials (RCTs) with the aim of providing clinicians with information on which to base decisions about choice of support surfaces for the prevention of pressure ulcers. Objective: To examine (1) which pressure-redistributing cushions, beds, mattress overlays and mattress replace- ments reduce the incidence of pressure ulcers compared with standard support surfaces and (2) how effective different pressure-redistributing surfaces are in preventing pressure ulcers, when compared with one another. 2. Methods Protocol and registration: The full Cochrane systematic review on which this article is based can be accessed from the Cochrane Database of Systematic Reviews (report number CD001735) (McInnes et al., 2011). This report adheres to the PRISMA method for reporting on systematic reviews (Moher et al., 2009).
  • 10. Eligibility criteria: RCTs and quasi-randomised trials comparing beds, mattresses, mattress overlays and cush- ions in any setting, on any clinical population, of any age, with any condition, which measured the incidence of new pressure ulcers. Trials which used only subjective mea- sures of outcome (e.g. skin condition ‘‘better’’ or ‘‘worse’’) were excluded, as were trials which reported only proxy outcome measures such as interface pressure. Search Strategy (including information sources): We searched, without language, publication status or date restriction, the Cochrane Wounds Group Specialised Register (searched 8 December 2010); The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 4, 2010); Ovid MEDLINE (1950 to November Week 3, 2010); Ovid MEDLINE In-Process and Oth EM to com Stra sen sion CIN dev wo 200 Coc pre we pub
  • 13. # E. McInnes et al. / International Journal of Nursing Studies 49 (2012) 345–359 347 er Non-Indexed Citations (December 07, 2010); Ovid BASE (1980–2010 Week 48) and EBSCO CINAHL (1982 3 December 2010). The Ovid MEDLINE search was bined with the Cochrane Highly Sensitive Search tegy for identifying randomised trials in MEDLINE: sitivity- and precision-maximising version (2008 revi- ) (Lefebvre et al., 2009). The Ovid EMBASE and EBSCO AHL searches were combined with the trial filters eloped by the Scottish Intercollegiate Guidelines Net- rk (SIGN) (Scottish Intercollegiate Guidelines Network, 9). The full electronic search strategy used in The hrane Central Register of Controlled Trials (CENTRAL) is sented in Box 1. Prior to conducting the electronic searches, experts re contacted to enquire about ongoing and recently lished trials in the area of wound care. Citations within ained reviews and relevant papers were scrutinised to ntify additional trials. Study selection: The titles and abstracts of the search ults were independently assessed for eligibility and vance by two authors and the full copies of all entially relevant trials were obtained. Decisions on l inclusion after full text assessment was made by one hor and checked by a second; disagreements were resolved by discussion with a third author. Rejected trials were checked by a third author. Data collection process (including data items): Details of
  • 14. eligible trials were extracted by two review authors independently and summarised using a data extraction sheet. Disagreements were resolved by discussion with a third author. Data extracted from each study included patient characteristics, care setting, key baseline variables (age, sex, baseline risk, baseline area of existing ulcers), description of the interventions, number of patients randomised to each intervention, description of any co- interventions/standard care, follow-up period, outcomes and acceptability/reliability of equipment if reported. If data were missing from reports, attempts were made to contact the study author to complete the information necessary for the analysis and risk of bias assessment. If trials were published more than once, they were maxi- mally data extracted and a primary reference cited. Risk of bias in individual trials: The methodological and reporting quality of each trial was assessed by a single author and checked by a second using a risk of bias assessment tool which addressed the fulfilment criteria as ‘low risk of bias’, ‘high risk of bias’ or ‘unsure’ (Higgins et al., 2009). This involved examining whether there was evidence of true randomisation; allocation concealment; baseline comparability of groups; blinded outcome assessment and intention-to-treat analysis. Eligible trials were also assessed for incomplete outcome data; drop-out rates and whether the study was free of selective outcome reporting. Dis- agreements were resolved by discussion with a third author. Summary measures (including synthesis of results): Analysis was conducted using RevMan software (Review Manager (RevMan) Version 5.0, 2008). If appropriate data were available from included trials, dichotomous variables of new pressure ulcers developed are presented as risk ratio (RR) with 95% confidence intervals (CIs). When continuous outcome variables, such as change in pressure
  • 15. ulcer size or time of pressure ulcer development, were measured, they were summarised using the mean difference (MD). Where possible, Grade 1 pressure ulcers (that is, those which resulted in non-blanchable redness of the skin) were separated from Grade 2 or higher pressure ulcers (Grade 2 generally refers to partial thickness loss of dermis and higher Grades 3 and 4, respectively, refer to full thickness tissue loss and full thickness tissue loss with exposed bone, tendon or muscle (EPUAP-NPUAP 2009)) in order to report on important clinical outcomes. Of the trials that included people with pre-existing pressure ulcers, only the incidence of new pressure ulcers was reported. Trials with similar patients, comparisons and outcomes were considered for pooled analysis. When there was more than one trial comparing similar devices using the same outcome measure (though possibly differing lengths of follow up), statistical heterogeneity was assessed using I2 and tested for by chi-squared test. A value of I2 greater than 50% indicated substantial heterogeneity and was consid- ered significant where p < 0.10 (Higgins et al., 2003). In the absence of significant statistical heterogeneity, trials with similar comparisons were pooled using a fixed effect model (Higgins et al., 2011). Where there was substantial statistical heterogeneity we pooled the data using the ox 1. Search strategy used in The Cochrane Central egister of Controlled Trials (CENTRAL). 1 MeSH descriptor Beds explode all trees 2 mattress* 3 cushion*
  • 16. 4 ‘‘foam’’ or transfoam 5 overlay* 6 ‘‘pad’’ or ‘‘pads’’ 7 ‘‘gel’’ 8 pressure NEXT relie* 9 pressure NEXT reduc* 10 pressure NEXT alleviat* 11 ‘‘low pressure’’ NEAR/2 device* 12 ‘‘low pressure’’ NEAR/2 support 13 constant NEAR/2 pressure 14 ‘‘static air’’ 15 alternat* NEXT pressure 16 air NEXT suspension* 17 air NEXT bag* 18 water NEXT suspension* 19 elevation NEAR/2 device* 20 clinifloat or maxifloat or vaperm or therarest or sheepskin or hammock or ‘‘foot waffle’’ or silicore
  • 17. or Pegasus or cairwave 21 (turn* or tilt*) NEXT (bed* or frame*) 22 kinetic NEXT (therapy or table*) 23 net NEXT bed* 24 ‘‘positioning’’ or ‘‘repositioning’’ 25 (#1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8 OR #9 OR #10 OR #11 OR #12 OR #13 OR #14 OR #15 OR #16 OR #17 OR #18 OR #19 OR #20 OR #21 OR #22 OR #23 OR #24) 26 MeSH descriptor Pressure Ulcer explode all trees 27 pressure NEXT (ulcer* or sore*) 28 decubitus NEXT (ulcer or sore*) 29 (bed NEXT sore*) or bedsore* 30 (#26 OR #27 OR #28 OR #29) 31 (#25 AND #30) E. McInnes et al. / International Journal of Nursing Studies 49 (2012) 345–359348 random-effects model (Higgins et al., 2011). For the purpose of meta-analysis it was assumed that risk ratio
  • 18. remained constant for different lengths of follow up, hence we pooled trials which followed participants for different lengths of time. Where pooling was inappropriate, the results of the trials were reported narratively. 3. Results Fifty-three eligible randomised trials were identified with a total of 16,285 study participants. Fig. 1 shows the study selection process. Of the 112 full-text articles assessed for eligibility, 59 were excluded for a variety of reasons as detailed in Fig. 1. The trials were conducted in a variety of settings including operating theatres, intensive care units, ortho- paedic hospital units, accident and emergency units, extended care facilities and nursing homes. Sample sizes ranged from 12 to 1972 participants and the reported follow-up periods for trials ranged from one day to 12 months. Similar timing of outcome assessment between groups under investigation was reported in 34 trials and these ranged from daily to weekly. The methodological quality of the included trials is presented in Table 1. Use of a randomly generated allocation sequence was evident in 24 trials (Bennett et al., 1998; Cadue et al., 2008; Cooper et al., 1998; Economides et al., 1995; Gentilello et al., 1988; Geyer et al., 2001; Gilcreast et al., 2005; Kemp et al., 1993; Keogh and Dealey, 2001; Lazzara and Buschmann, 1991; McGowan et al., 2000; Mistiaen et al., 2009; Nixon et al., 2006, 1998; Price et al., 1999; Russell and Lichtenstein, 2000; Russell et al., 2003; Sanada et al., 2003; Santy et al., 1994; Schultz et al., 1999; Summer et al., 1989; Tymec et al., 1997; Vanderwee et al., 2005; Vyhlidal et al., 1997). Methods of randomisation used
  • 19. included table of random numbers, automated phone systems and computerised random number generators. Adequate allocation concealment – defined as those involved in enrolling participants not being able to foresee allocation through the use of central allocation, including telephone or web-based randomisation, or sequentially numbered, opaque, sealed envelopes – was evident in 16 Recor ds identified throu gh database searching (n = 184) Sc re en in g In cl ud ed E lig ib ili ty
  • 20. Id en ti fi ca ti on Additional records ide ntifie d through other sources (n = 11) Records afte r duplicates re mov ed (n =19 5 ) Recor ds screened (n = 19 5) Reco rds ex clud ed (n = 83) Full-te xt article s as sessed for eligibility (n = 112) Full-text articles excluded, wit h reason s (n = 59) Literatur e revi ews (n=2)
  • 21. Incomple te data (n=8) Did not report clinical outcome (n=20) Not a trial (n=11) Different intervention (n=9) Other inc lusion criteria not met (n=9 ) Total trials in review (n = 53) Fig. 1. PRISMA flow diagram of study selection. tria 199 199 et a Tay Wh rep et a Gra Tab Risk St An Ar Be
  • 24. Ru Sa Sa Sc Sid St Su Ta Ta Th Ty Va Vy W E. McInnes et al. / International Journal of Nursing Studies 49 (2012) 345–359 349 ls (Cadue et al., 2008; Cobb et al., 1997; Cooper et al., 8; Economides et al., 1995; Geyer et al., 2001; Gray et al., 8; Jolley et al., 2004; Keogh and Dealey, 2001; Mistiaen l., 2009; Nixon et al., 2006, 1998; Sanada et al., 2003; lor, 1999; Theaker et al., 2005; Vanderwee et al., 2005; itney et al., 1984). Blinding of outcome assessment was
  • 25. orted in 10 trials (Cavicchioli and Carella, 2007; Conine l., 1990, 1994; Feuchtinger et al., 2006; Geyer et al., 2001; y et al., 1998; Nixon et al., 1998; Russell et al., 2000; Schultz, 1998; Theaker et al., 2005). Twenty-five trials adequately addressed incomplete outcome data, for exam- ple, by either having balanced or no missing outcome data, or having missing data that have been imputed using appropriate methods (Aronovitch et al., 1999; Bennett et al., 1998; Cadue et al., 2008; Cavicchioli and Carella, 2007; Cobb et al., 1997; Conine et al., 1990, 1993, 1994; Cooper et al., 1998; Gebhardt et al., 1996; Geyer et al., 2001; Gilcreast et al., 2005; Laurent, 1997; Lim et al., 1988; McGowan et al., le 1 of bias of included trials. udy Adequate sequence generation Allocation concealment Blinding Incomplete outcome data addressed Free of
  • 26. selective reporting Groups similar at baseline Timing of outcome assessment similar in all groups dersen et al. (1982) Unclear Unclear Unclear Unclear Low risk Low risk Low risk onovitch et al. (1999) Unclear Unclear Unclear Low risk Low risk Low risk Low risk nnett et al. (1998) Low risk Unclear Unclear Low risk High risk Low risk High risk due et al. (2008) Low risk Low risk Unclear Low risk Unclear Low risk Low risk vicchioli and Carella (2007) Unclear Unclear Low risk Low risk Low risk High risk Low risk bb et al. (1997) Unclear Low risk Unclear Low risk Low risk
  • 27. High risk High risk llier (1996) Unclear Unclear High risk Unclear Low risk Unclear High risk nine et al. (1990) Unclear Unclear Low risk Low risk Unclear Low risk Unclear nine et al. (1993) Unclear Unclear Unclear Low risk Low risk Low risk Low risk nine et al. (1994) Unclear Unclear Low risk Low risk Low risk Low risk Low risk oper et al. (1998) Low risk Low risk Unclear Low risk Low risk Low risk Low risk echsel and Conine (1985) Unclear Unclear Unclear Unclear Low risk Low risk Low risk onomides et al. (1995) Low risk Low risk Unclear Unclear Low risk Low risk Low risk ing et al. (1964) Unclear Unclear Unclear Unclear Low risk Unclear Low risk ton-Smith et al. (1982) High risk Unclear Unclear Unclear High risk Low risk High risk uchtinger et al. (2006) Unclear Unclear Low risk Unclear Low risk Low risk Low risk bhardt et al. (1996) Unclear Unclear Unclear Low risk Unclear Low risk Unclear ntilello et al. (1988) Low risk Unclear Unclear Unclear Unclear
  • 28. Low risk High risk yer et al. (2001) Low risk Low risk Low risk Low risk Low risk Low risk Low risk lcreast et al. (2005) Low risk High risk High risk Low risk Unclear Unclear Low risk ldstone et al. (1982) Unclear Unclear Unclear High risk Low risk Low risk Low risk ay and Campbell (1994) Unclear Unclear Unclear Unclear Unclear Unclear High risk ay et al. (1998) Unclear Low risk Low risk Unclear Unclear Unclear Low risk nningberg et al. (2000) Unclear Unclear Unclear Unclear High risk Low risk Unclear mpton (1997) Unclear Unclear Unclear Unclear Unclear Unclear Unclear fman et al. (1994) Unclear Unclear High risk Unclear High risk Low risk Low risk man et al. (1993) Unclear Unclear Unclear High risk High risk Low risk Low risk lley et al. (2004) Unclear Low risk High risk High risk High risk Unclear Low risk mp et al. (1993) Low risk Unclear Unclear High risk High risk Unclear Low risk ogh and Dealey (2001) Low risk Low risk Unclear High risk
  • 29. High risk Low risk Low risk urent (1997) Unclear Unclear High risk Low risk Low risk Low risk Low risk zzara and Buschmann (1991) Low risk Unclear Unclear Unclear Low risk Low risk Low risk et al. (1988) Unclear Unclear Unclear Low risk Low risk Low risk Low risk cGowan et al. (2000) Low risk Unclear High risk Low risk Low risk Low risk Low risk istiaen et al. (2009) Low risk Low risk High risk Unclear Unclear Low risk Low risk xon et al. (1998) Low risk Low risk Low risk Low risk Low risk High risk Low risk xon et al. (2006) Low risk Low risk High risk Low risk Low risk Low risk Low risk ice et al. (1999) Low risk Unclear High risk Unclear Low risk Low risk Low risk ssell et al. (2000) Low risk Unclear Low risk Low risk Low risk Low risk Low risk ssell et al. (2003) Low risk Unclear High risk Low risk Low risk Low risk Low risk nada et al. (2003) Low risk Low risk Unclear High risk Low risk Low risk Low risk nty et al. (1994) Low risk Unclear Unclear Unclear Low risk
  • 30. Low risk Low risk hultz et al. (1999) Low risk High risk Low risk Low risk Low risk Low risk Low risk eranko et al. (1992) Unclear Unclear Unclear Unclear Low risk Unclear Unclear apleton (1986) Unclear Unclear Unclear Low risk Unclear Low risk Unclear mmer et al. (1989) Low risk Unclear Unclear Low risk Low risk Unclear Unclear kala et al. (1996) Unclear High risk Unclear Low risk Low risk Low risk Unclear ylor (1999) Unclear Low risk Unclear Unclear High risk Low risk Unclear eaker et al. (2005) Unclear Low risk Low risk Unclear Low risk Low risk Unclear mec et al. (1997) Low risk Unclear Unclear Unclear Low risk Unclear Unclear nderwee et al. (2005) Low risk Low risk Unclear Unclear Unclear Low risk Unclear hlidal et al. (1997) Low risk Unclear Unclear Low risk Low risk High risk Unclear hitney et al. (1984) Unclear Low risk Unclear Low risk Low risk Unclear Low risk
  • 31. E. McInnes et al. / International Journal of Nursing Studies 49 (2012) 345–359350 2000; Nixon et al., 2006, 1998; Russell and Lichtenstein, 2000; Russell et al., 2003; Schultz et al., 1999; Stapleton, 1986; Summer et al., 1989; Takala et al., 1996; Vyhlidal et al., 1997; Whitney et al., 1984). Thirty-three trials were judged to be free of selective outcome reporting (Andersen et al., 1982; Aronovitch et al., 1999; Cavicchioli and Carella, 2007; Cobb et al., 1997; Collier, 1996; Conine et al., 1993, 1994; Cooper et al., 1998; Daechsel and Conine, 1985; Economides et al., 1995; Ewing et al., 1964; Feuchtinger et al., 2006; Geyer et al., 2001; Goldstone et al., 1982; Laurent, 1997; Lazzara and Buschmann, 1991; Lim et al., 1988; McGowan et al., 2000; Nixon et al., 2006, 1998; Price et al., 1999; Russell and Lichtenstein, 2000; Russell et al., 2003; Sanada et al., 2003; Santy et al., 1994; Schultz et al., 1999; Sideranko et al., 1992; Summer et al., 1989; Takala et al., 1996; Taylor, 1999; Theaker et al., 2005; Tymec et al., 1997; Vyhlidal et al., 1997; Whitney et al., 1984). Thirty-seven trials reported that participant groups under investigation were similar regard- ing prognostic factors (including age, sex, continence and/or reasons for immobility) (Andersen et al., 1982; Aronovitch et al., 1999; Bennett et al., 1998; Cadue et al., 2008; Conine et al., 1990, 1993, 1994; Cooper et al., 1998; Daechsel and Conine, 1985; Economides et al., 1995; Exton-Smith et al., 1982; Feuchtinger et al., 2006; Gebhardt et al., 1996; Gentilello et al., 1988; Geyer et al., 2001; Goldstone et al., 1982; Gunningberg et al., 2000; Hofman et al., 1994; Inman et al., 1993; Keogh and Dealey, 2001; Laurent, 1997; Lazzara and Buschmann, 1991; Lim et al., 1988; McGowan et al., 2000; Mistiaen et al., 2009; Nixon et al., 2006; Price et al., 1999; Russell and Lichtenstein, 2000; Russell et al., 2003; Sanada et al., 2003; Santy et al., 1994; Schultz et al., 1999; Stapleton, 1986; Takala et al., 1996; Taylor, 1999; Theaker et al., 2005; Vanderwee et al., 2005).
  • 32. Thirteen trials included patients with pre-existing pressure ulcers. Of these, seven included only those with Grade 1 pressure ulcers (Cavicchioli and Carella, 2007; Exton-Smith et al., 1982; Hofman et al., 1994; Keogh and Dealey, 2001; Mistiaen et al., 2009; Nixon et al., 1998; Vanderwee et al., 2005), three included Grades 1 and 2 (Bennett et al., 1998; Nixon et al., 2006; Santy et al., 1994), and one study included only those that were Grade 4 (Economides et al., 1995). For two trials it was not clear what grades of pressure ulcer were included (Feuchtinger et al., 2006; Lazzara and Buschmann, 1991) and for 14 trials it was unclear or unstated whether pre-existing pressure ulcers were included. Trials were classified into those that evaluated ‘low- tech’ devices, ‘high-tech’ devices and other types of support surfaces. This classification system is commonly used, for example in national clinical guidelines (National Institute for Clinical Excellence, 2003). Twenty-three trials evaluated low-tech constant low- pressure support surfaces (foam body supports, sheep- skin overlay, heel devices and mattresses). Twenty-one trials evaluated high tech support surfaces (alternating pressure redistribution devices, low-air-loss beds and air fluidised beds). Other support surfaces included kinetic turning tables (two trials), profiling beds (one study), operating table overlays (six trials) and seat cushions (four trials). Characteristics of the included Tables 1 and 2, respectively. Table 3 shows the results of analyses. 4. Comparisons: ‘low-tech’ constant low pressure support surfaces
  • 33. 4.1. Comparisons between ‘low-tech’ constant low pressure support surfaces and standard foam surfaces Nine trials evaluated a standard foam hospital mat- tress compared with a ‘low-tech’ constant low pressure support surface, including: water-filled mattresses (Andersen et al., 1982); alternative foam mattresses (Collier, 1996; Gray and Campbell, 1994; Hofman et al., 1994; Russell et al., 2003; Santy et al., 1994); bead beds (Goldstone et al., 1982); visco-elastic mattresses (Gun- ningberg et al., 2000) and other low-tech mattresses (Takala et al., 1996). The five trials (Collier, 1996; Gray and Campbell, 1994; Hofman et al., 1994; Russell et al., 2003; Santy et al., 1994) comparing foam alternatives with the standard hospital mattress were pooled using a random effects model (I2 = 77%, x2 13.24, df = 3, p = 0.004). This analysis yielded a pooled risk ratio of 0.40 (95% CI 0.21–0.74) or a relative reduction of pressure ulcer incidence of 60% (95% CI 26– 79%), favouring the use of the foam alternative support surfaces. The high heterogeneity in standard hospital mattresses amongst these trials led to a separate meta- analysis of four UK-based trials (Collier, 1996; Gray and Campbell, 1994; Russell et al., 2003; Santy et al., 1994) as variation in the standard hospital mattress is likely to be lower in the UK. This analysis showed a significant benefit of alternative foam over standard foam being maintained (RR 0.41, 95% CI 0.19–0.87). As heterogeneity in this pooled group was high (I2 = 84%, x2 12.41, df = 2, p = 0.002), Russell et al. (2003) was removed as it was an outlier. Hetero- geneity was reduced (I2 = 39%) and the pooled results maintained a significant effect in favour of the alternative foam support over the standard support surface (RR 0.29, 95% CI 0.16–0.52).
  • 34. The four remaining trials in this category evaluated a range of products against the standard hospital mattresses. The incidence and severity of pressure ulcers in patients deemed at ‘high risk’ were reduced when patients were placed on either a bead filled mattress (Goldstone et al., 1982) (RR 0.32, 95% CI 0.14–0.76), a water-filled mattress (Andersen et al., 1982) (RR 0.35, 95% CI 0.15–0.79) or a constant low-pressure mattress (Takala et al., 1996) (RR 0.06, 95% 0–0.99). Gunningberg et al. (2000) did not find any significant difference in pressure ulcer incidence for those allocated to a visco-elastic foam trolley mattress (in ED) and standard mattress (on the ward) (4/48, 8%) compared with those assigned to a standard trolley mattress (in ED) and standard mattress (on the ward) (8/53, 15%) (p = 0.36). 4.2. Comparisons between alternative foam support surfaces Three trials (Gray et al., 1998; Kemp et al., 1993; Vyhlidal et al., 1997) compared different foam alternatives trials and risk of bias assessment of the trials appear in Table 2 Reported follow-up alternating air
  • 35. ess (n = 155) 10 days col (n = 35) vs. 30 days 8) Unclear otation mattress 7 days 18) 6 months 6) vs. foot waffle Unclear (n = 50) 10 days s (n = 50) 10 days upports (43) Unclear isco-elastic foam ttress (A&E) and 14 days or until discharge rd mattress 14 days . standard care Mean: 7 days (experimental group), 7.9 days
  • 36. (control group) lid foam overlay 1 month ss (n = 33) 6 months eepskin overlay, tandard hospital devices as Until discharge or transfer = 272) Unclear attress and and cushion Median: 8–14 days (experimental group), 9–17 days (control group) (n = 441) vs. NHS 14 days air mattress Mean: 9.4 days E .
  • 39. 3 5 1 Characteristics of included trials. Study (year) Participants Grade 1 pressure ulcers included Intervention (sample size) ‘Low tech’ constant low pressure support surfaces (n = 23)a Andersen et al. (1982)b Patients from the acute setting at high risk of pressure ulcer development (Anderson Scale) No Standard hospital mattress (n = 161) vs. mattress (n = 166) vs. water filled mattr Cadue et al. (2008) Patients from ICU, aged > 18 years. Waterlow score > 10 Nod Foam body support with standard proto Standard protocol (n = 35) Collier (1996) Patients from a general medical ward No Comparison of 8 foam mattresses (n = 7
  • 40. Cooper et al. (1998) Patients aged > 65 years from mixed emergency and orthopaedic trauma wards Nod Dry flotation mattress (n = 49) vs. dry fl (n = 51) Ewing et al. (1964) Elderly patients confined to bed, with reduced mobility as a result of neurological disorders, fixed joints or peripheral vascular disease Unclear Sheepskin (n = 18) vs. No sheepskin (n = Gilcreast et al. (2005) Participants from military tertiary academic medical centres, moderate-high risk of pressure ulcer development No Heel protector (n = 77) vs. egg crate (n = 8 (n = 76) Gray and Campbell (1994) Patients from orthopaedic trauma, vascular and medical oncology units, with no breaks in the skin. Waterlow score > 15
  • 41. Nod Mattress (n = 50) vs. standard mattress Gray et al. (1998) Patients admitted to a district general hospital, weight < 160 kg Nod Foam mattress (n = 50) vs. foam mattres Goldstone et al. (1982) Patients aged > 60 years with a femur fracture Unclear Bead bed system (n = 32) vs. standard s Gunningberg et al. (2000) c Patients aged > 65 years with a suspected hip fracture, admitted via A&E Nod Visco-elastic foam mattress (A&E) and v overlay (ward) (n = 48) vs. standard ma standard overlay (ward) (n = 53) Hofman et al. (1994) Patients with a fractures neck of femur. Dutch consensus risk scale score > 8 Yes Cubed foam mattress (n = 21) vs. standa (n = 23) Jolley et al. (2004) Patients aged > 18 years, low – moderate risk of developing a pressure ulcer
  • 42. No Sheepskin mattress overlay (n = 270) vs (n = 269) Kemp et al. (1993) Patients aged > 65 from general medical, acute geriatric, long-term care wards. Braden score > 16 Nod Convoluted foam overlay (n = 45) vs. so (39) Lazzara and Buschmann (1991) Nursing home residents at risk of pressure ulcer development. Norton score > 15 Unclear Air-filled overlay (n = 33) vs. gel mattre McGowan et al. (2000) Patients aged > 60 years from an extended care facility, at risk of developing a pressure ulcer, use of a wheelchair � 3 h a day. Norton score � 14 Nod Standard hospital mattress and sheets, sh heel and elbow protectors (n = 155) vs. s mattress and sheets and other low-tech required (n = 142)
  • 43. Mistiaen et al. (2009) Patients from an aged care facility and rehabilitation centre Yes Sheepskin (n = 271) vs. standard care (n Russell et al. (2003) Patients from acute elderly, orthopaedic and rehabilitation units, aged > 60 years Unclear Visco-polymer energy absorbing foam m cushion (n = 562) vs. standard mattress (n = 604) Santy et al. (1994) Patients aged > 55 years with a hip fracture or pressure ulcers Yes Comparison between 4 foam mattresses standard mattress (n = 64) Sideranko et al. (1992) b Patients from ICU > 48 h Nod Alternating air overlay (n = 20) vs. Static (n = 20) vs. Water mattress (n = 17) Reported
  • 44. follow-up olyether foam pad 34) Unclear = 21) vs. standard 14 days pillow (n = unclear) Unclear ss replacement Range: 10 – 21 days r – SSI/Hillrom] Range: 1–60 days w-pressure setting tinuous low- – Hill Rom] 2 weeks 2) vs. Static air = 61) 40 days s. Silicore fibre 3 months
  • 45. ) vs. Silicore fibre 3 months uidised bed (n = 6) 2 weeks ) vs. large cell ripple 2 weeks ys/mattresses/beds) pports (overlays/ Unclear vs. Alternating 20 days (maximum) d ICU bed (n = 49) Mean: 17 days ) vs. Alternating 60 days mattress (post-op) ress (ICU) and s. standard mattress attress (post-op) tress (ICU) and ost-op) (n = 77) Unclear = 40) vs. alternating
  • 46. 0) 14 days . Single layer air cell mattress (n = 35) Unclear ressure ernative alternating ributing cushion Until discharge lternating pressure 2 weeks post-ICU discharge E . M cIn n e s e t a
  • 48. ie s 4 9 (2 0 1 2 ) 3 4 5 – 3 5 9 3 5 2 Table 2 (Continued ) Study (year) Participants Grade 1 pressure ulcers included Intervention (sample size)
  • 49. Stapleton (1986) b Female elderly patients with a fractured neck of femur. Norton score < 14. Nod Large cell ripple overlay (n = 32) vs. p (n = 34) vs. Silicore fibre overlay (n = Takala et al. (1996) Patients from ICU with an expected length of stay > 5 days Unclear Continuous low-pressure mattress (n hospital foam mattress (n = 19) Tymec et al. (1997) Patients from large hospital. Braden score < 16 Nod Foot waffle (n = unclear) vs. hospital Vyhlidal et al. (1997) Newly admitted patients to a skilled nursing facility with an estimated stay � 10 days. Braden score < 18 Nod Foam overlay (n = 20) vs. fibre mattre (n = 20) ‘High tech’ pressure support surfaces (n = 18)a Bennett et al. (1998) Acute and long term incontinent patients. In bed > 16 h a day Yes Low-air-loss hydrotherapy [Clensicai (n = 42) vs. standard care (n = 56)
  • 50. Cavicchioli and Carella (2007) Acute and long-term care patients at risk of pressure ulcers and an expected admission � 2 weeks. Braden score < 17 or mobility or subscales < 3 respectively Yes High-tech mattress on alternating lo (n = 86) vs. high-tech mattress on con pressure setting (n = 84) [both due 2 Cobb et al. (1997) Patients aged > 18 years from hospital wards and ICU. Expected length of stay 1–2 weeks. Nod Low-air-loss bed [KinAir – KCI] (n = 6 mattress overlay [Waffle – EHOB] (n Conine et al. (1990) Patients aged 18–55 years with evidence of chronic neurological disease Nod Alternating pressure overlay(n = 72) v overlay (n = 76) Daechsel and Conine (1985) Patients from a long-term care hospital with chronic neurological conditions and considered at high risk of
  • 51. pressure ulcers Nod Alternating pressure mattress (n = 16 overlay (n = 16) Economides et al. (1995) Patients with stage 4 pressure ulcers requiring myocutaneous flap closure No Dry flotation mattress (n = 6) vs. air-fl Exton-Smith et al. (1982) Newly admitted geriatric patients with a fractured neck of femur Yes Alternating pressure mattress (n = 31 mattress (n = 31) Gebhardt et al. (1996) ICU patients with an admission > 3 days. Norton score < 1 Nod Alternating pressure supports (overla (n = 23) vs. constant low pressure su mattresses/beds) (n = 20) Hampton (1997) No details provided Unclear Alternating pressure mattress (n-36) pressure mattress (n = 39) Inman et al. (1993) Patients aged > 17 years, APACHE score > 15. ICU
  • 52. stay > 3 days Unclear Low-air-loss beds (n = 49) vs. standar Nixon et al. (2006) Patients aged > 55 years with an expected length of hospital stay � 7 days. Braden score = 1–2 Yes Alternating pressure overlay (n = 990 pressure mattress (n = 982) Laurent (1997) Patients aged > 15 years and admitted for major cardiovascular surgery. Hospital stay � 5 days with an ICU admission Unclear Standard mattress (ICU) and standard (n = 80) vs. Alternating pressure matt standard mattress (post-op) (n = 80) v (ICU) vs. Continuous low-pressure m (n = 75) vs. Alternating-pressure mat continuous low-pressure mattress (p Price et al. (1999) Patients aged > 60 years with a fractured neck of femur. Medley score > 25 Unclear Low pressure mattress and cushion (n
  • 53. pressure mattress and cushion (n = 4 Sanada et al. (2003) Patients from an acute care unit. Bed bound and requiring head elevations. Braden score � 16. Nod Double layer air cell overlay (n = 37) vs overlay (n = 36) vs. standard hospital Taylor (1999) Patients aged > 16 years Nod Alternating pressure mattress with p redistributing cushion (n = 22) vs. alt pressure system with pressure redist (n = 22) Theaker et al. (2005) Patients aged > 80 years from ICU. At high risk of pressure ulcer development Nod Alternating pressure bed (n = 30) vs. a mattress (n = 32) Vanderwee et al. (2005) Patients aged > 18 years from surgical, internal medicine Yes Alternating pressure mattress with air cushion for sitting and air cushion
  • 54. Unclear convoluted foam 8 days e] (n = 112) vs. 7 days m cushion 3 months = 73) 3 months ing mattress and (n = 85) vs. ng mattress 5 days entional bed Unclear tandard foam 12 months (n = 50) Range: 5 – 10 days d foam cushion 5 months ard mattress 8 days Conventional 7 days vs. usual care 6 days ntional bed with Unclear
  • 57. 5 9 3 5 3 or geriatric hospital wards. An expected hospital stay of � 3 days. Braden score < 17. (n = 222) vs. visco-elastic foam mattress for sitting (n = 225) Whitney et al. (1984) Patients from medical-surgical wards in bed for � 20 h a day Unclear Alternating pressure mattress (n-25) vs. bed (n = 26) ‘Other’ pressure support surfaces (n = 12)a Aronovitch et al. (1999) Patients aged > 18 years, undergoing surgery (>3 h) under general anaesthesia Nod Alternating pressure system [MicroPuls conventional management (n = 105) Conine et al. (1993) Patients aged > 60 years from an extended
  • 58. care facility and high risk of a pressure ulcer. Sitting in a wheelchair for � 4 h/day No Slab cushion (n = 144) vs. contoured foa (n = 144) Conine et al. (1994) Elderly patients in an extended care hospital and at high risk of pressure ulcers. Sitting in a wheelchair for � 4 h/ day. Norton score < 14. Unclear Gel cushion (n = 68) vs. foam cushion (n Feuchtinger et al. (2006) Patients aged > 18 years, scheduled for cardiac surgery with extracorporeal circulation Unclear Operating table with water filled warm thermoactive visco elastic foam overlay operating table with water filled warmi (n = 90) Gentilello et al. (1988) Critically ill patients in a surgical ICU, immobilised due to head injury, spinal injuries or traction
  • 59. Unclear Kinetic treatment table (n = 27) vs. conv (n = 38) Geyer et al. (2001) Patients aged > 65 years, in a wheelchair. Tolerance of sitting in a wheelchair � 6 h, weight > 250 lbs. Braden score � 18 No Pressure reducing cushion (n = 15) vs. s cushion (n = 17) Keogh and Dealey (2001) Patients aged > 18 years, from surgical and medical wards. Waterlow score = 15–25 Yes Profiling bed (n = 50) vs. flat-based bed Lim et al. (1988) Patients aged > 60 years from an extended care facility. Use of a wheelchair � 3 h/day. Norton score � 14 No Foam slab cushion (n = 26) vs. contoure (n = 26) Nixon et al. (1998) Patients aged > 55 years, admitted for major general, gynaecological or vascular surgery in supine or lithotomy position
  • 60. Yes Dry visco elastic pad (n = 222) vs. stand (n = 224) Russell et al. (2000) Patients aged > 18 years, undergoing scheduled cardiothoracic surgery under general anaesthesia and � long Nod Alternating pressure overlay (n = 98) vs. care (n = 100) Schultz et al. (1999) Patients aged > 18 years, admitted for surgery � 2 h in lithotomy position Nod Experimental mattress overlay (n = 206) (n = 207) Summer et al. (1989) Patients from ICU with sepsis, pneumonia, respiratory failure, drug overdose, metabolic coma, stroke, neuromuscular disease or ARDS Unclear Kinetic treatment table (n = 43) vs. conve 2-hourly turning (n = 43) a Does not include trials appearing under another subheading. b Paper is also considered under ‘low-tech constant low
  • 61. pressure support surfaces’. c Paper is also considered under ‘other pressure support surfaces’. d Existing pressure ulcers part of exclusion criteria. Table 3 Results of analyses – pressure ulcer incidence. Comparison Number of trials (authors) Participants Risk ratio (95% CI) p-Value* ‘Low tech’ constant low pressure support surfaces Comparison between low-tech CLP and SFM supports Bead bed system vs. Standard supports 1 (Goldstone et al.) 75 0.32 (0.14, 0.76) – Water filled mattress vs. Standard hospital mattress 1 (Andersen et al.) 316 0.35 (0.15, 0.79) – Constant low pressure mattress vs. Standard support 1 (Takala et al.) 40 0.06 (0 to 0.99) – Pooled trials Foam alternatives vs. Standard hospital mattress 5 (Collier, Gray 94, Hofman, Russell 03, Santy) 2016 0.40 (0.21, 0.74) p = 0.004
  • 62. Foam alternatives vs. Standard hospital mattress (UK trials only) 4 (Collier, Gray 94, Russell 03, Santy) 1980 0.41 (0.19, 0.87) p = 0.020 Foam alternatives vs. Standard hospital mattress (Russell et al., 2002 excluded) 3 (Collier. Gray 94. Santy) 814 0.29 (0.16, 0.52) p < 0.0001 Comparisons between AFM supports Standard mattress vs. 4 foam mattresses 1 (Santy et al.) 505 0.36 (0.22, 0.59) – Fibre mattress replace vs. foam overlay 1 (Vyhlidal et al.) 40 0.42 (0.18, 0.96) – Convoluted foam overlay vs. Solid foam overlay 1 (Kemp et al.) 84 0.66 (0.37, 1.16) – Foam body support (+standard protocol) vs. Standard protocol 1 (Cadue et al.) 70 0.16 (0.05, 0.49) – Comparison between dry flotation mattresses 1 (Cooper et al.) 84 0.63 (0.16, 2.47) –
  • 63. Air filled overlay vs. Gel mattress 1 (Lazzara) 66 0.80 (0.24, 2.72) – Pooled trials: Comparison between sheepskins (all pressure ulcer grades) 3 (Jolley, McGowan, Mistaein) 1281 0.48 (0.31, 0.74) p = 0.0008 Comparison between sheepskins (pressure ulcers Grade 2 and above) 3 (Jolley, McGowan, Mistaein) 1281 Fixed effect: p = 0.04 0.56 (0.32, 0.97) Random effect: p = 0.09 0.60 (0.34, 1.08) ‘High tech’ pressure support surfaces AP: Comparison between AP and SFM supports Pooled trials: Alternating air-mattress vs. Overlay 2 (Andersen, Sanada) 409 0.31 (0.17, 0.58) p = 0.0002 AP: Comparison between AP and CLP supports Pooled trials:
  • 64. Silicore vs. foam overlays 4 (Conine 90, Daeschel, Stapleton, Whitney) 31 0.91 (0.72, 1.16) p = 0.46 Alternating pressure device vs. static water/ air mattresses 3 (Andersen, Sideranko, Price) 458 1.31 (0.51, 3.35) p = 0.57 Alternating pressure devices vs. constant low-pressure support 10 (Andersen, Cavicchioli, Conine 90, Daeschel, Gebhardt, Price, Sideranko, Stapleton, Vanderwee, Whitney) 1606 0.85 (0.64, 1.13) p = 0.28 LAL beds Alternating pressure device vs. static water/ air mattresses 1 (Bennett et al.) 98 2.67 (0.86, 8.27) – Pooled trials: Comparison between LAL beds 2 (Inman, Cobb) 221 0.33 (0.16,
  • 65. 0.67) p = 0.002 Air-fluidised beds Air fluidised bed vs. dry flotation mattress 1 (Economides et al.) 12 1.00 (0.20, 4.95) – Other pressure supports Kinetic turning tables Pooled trials: Comparison between kinetic turning table and conventional bed 2 (Gentillelo, Summer) 151 1.23 (0.57, 2.65) p = 0.59 Operating table overlays Water filled warming mattress and overlay vs. water filled warming mattress 1 (Feuchtinger et al.) 175 1.53 (0.69, 3.39) – Dry visco-elastic pad vs. standard mattress 1 (Nixon et al., 98) 65 0.53 (0.33, 0.85) – Pooled trials: Alternating pressure system intraoperatively vs. conventional care
  • 66. 2 (Aronovitch, Russell 00) 368 0.21 (0.06, 0.70) p = 0.01 Seat cushions Slab cushion vs. contoured foam cushion 1 (Conine et al., 93) 248 1.00 (0.84, 1.18) – E. McInnes et al. / International Journal of Nursing Studies 49 (2012) 345–359354 and eva pre ma (RR pre ing 0.6 com Gra (Gr 4.3. com to s et a wa 4.2 pre she tria
  • 68. * E. McInnes et al. / International Journal of Nursing Studies 49 (2012) 345–359 355 are reported as individual results below as the luated interventions are heterogeneous. Vyhlidal et al. (1997) found a significant reduction in ssure ulcer incidence in people randomised to a fibre ttress replacement when compared with a foam overlay 0.42, 95% CI 0.18–0.96). No significant differences in ssure ulcer incidence rates were found when compar- a convoluted foam overlay and a solid foam overlay (RR 6, 95% CI 0.37–1.16) (Kemp et al., 1993) or in parison of two foam mattresses, Transfoam (one de 4 ulcer) and Transfoamwave (one Grade 2 ulcer) ay et al., 1998). Other ‘low-tech’ support surfaces with various parisons Three trials evaluating the use of sheepskins compared tandard care were pooled (Jolley et al., 2004; McGowan l., 2000; Mistiaen et al., 2009). A random effects model s used as heterogeneity was substantial (I2 = 52%, x2 0, df = 2, p = 0.12). There were significantly fewer ssure ulcers of any grade amongst those allocated to epskins (RR 0.48, 95% CI 0.31–0.74). Across the three ls, out of 1281 participants, 51 ulcers were Grade 2 and her (3 participants developed an ulcer of Grades 3 or 4)
  • 69. most ulcers were Grade 1. An analysis examining de 2 and higher pressure ulcers yielded significant ults (RR 0.56, 95% CI 0.32–0.97) using a fixed effects lysis as (I2 = 3%, x2 2.06, df = 2, p = 0.36). However, a dom effects analysis was also undertaken due to the thodological heterogeneity (in terms of the participants quality of the trials), and this was not significant (RR 0, 95% CI 0.34–1.08). A significant reduction in pressure ulcer incidence s found in a study comparing a foam body support h a standard care protocol which included a water ttress, half seated position and massages (RR 0.16, CI 0.05–0.49) (Cadue et al., 2008). A comparison of a l support surface (foot waffle) with elevation of heels ng a hospital pillow, reported the incidence of ssure ulcers in the foot waffle group (n = 6) to be le that of the comparison group (n = 2) (study group bers were not specified) (Tymec et al., 1997). ther evaluation of a foot waffle (5/76), egg crate 87) and bunny boot (3/77) showed no differences, ever, it was not clear whether the results related to number of ulcers or the number of people with ers (Gilcreast et al., 2005). Comparisons of two dry flotation mattresses (Cooper l., 1998); a gel mattress and an air filled overlay (Lazzara Buschmann, 1991); alternating air overlay, static air ttress and a water mattress (Sideranko et al., 1992)
  • 70. and a large cell ripple mattress, polyether foam bed and a Spenco pad (Stapleton, 1986), found no significant differences. 5. Comparisons: ‘high-tech’ pressure support surfaces 5.1. Comparisons between alternating pressure supports and standard hospital mattress Two trials which compared alternative pressure sup- ports compared with a standard hospital mattress (Andersen et al., 1982; Sanada et al., 2003) were pooled using a fixed effect model (I2 = 0%, x2 0.02, df = 1, p = 0.0002). There was a significant reduction in pressure ulcer development favouring the alternating pressure surface (RR 0.31, 95% CI 0.17–0.58). 5.2. Comparisons between alternating pressure supports and constant low pressure supports No significant differences were found between Silicore or foam overlays and alternating pressure devices when pooling four studies (RR 0.91; 95% CI 0.72–1.16) (Conine et al., 1990; Daechsel and Conine, 1985; Stapleton, 1986; Whitney et al., 1984). Nor were significant differences found in a pooled analysis comparing alternating pressure devices and static water or static air mattresses (Andersen et al., 1982; Price et al., 1999; Sideranko et al., 1992) (RR 1.31, 95% CI 0.51–3.35). A pooled random effects analysis of 10 RCT’s comparing various constant low-pressure devices and alternating- pressure devices (Andersen et al., 1982; Cavicchioli and Carella, 2007; Conine et al., 1990; Daechsel and Conine,
  • 71. 1985; Gebhardt et al., 1996; Price et al., 1999; Sideranko et al., 1992; Stapleton, 1986; Vanderwee et al., 2005; Whitney et al., 1984) found no significant difference between the devices (RR 0.85; 95% CI 0.64–1.13). A comparison of various combinations of standard, constant low-pressure and alternating pressure mattresses showed no significant benefits of using alternating pressure in surgical intensive care patients intra- and post-ICU (Laurent, 1997). 5.3. Comparisons between different alternating pressure devices A two-layer large cell ripple alternating pressure device was found to be significantly more effective in preventing pressure ulcers compared with another alternating-pres- sure device (16% vs. 34%, p > 0.05) (Exton-Smith et al., 1982). No other significant differences were observed in any of the other four trials in this group. le 3 (Continued ) mparison Number of trials (authors) Participants Risk ratio (95% CI) p-Value* 1 (Lim et al.) 52 1.06 (0.75, 1.49) – at cushion vs. standard cushion 1 (Geyer et al.) 32 0.68 (0.33, 1.42) – y cushion vs. foam cushion 1 (Conine et al., 94) 141 0.61 (0.37, 1.00) – p-values only reported for pooled analyses.
  • 72. E. McInnes et al. / International Journal of Nursing Studies 49 (2012) 345–359356 5.4. Low-air-loss and air-fluidised beds Three trials evaluated the use of low-air-loss beds in preventing pressure ulcers (Bennett et al., 1998; Cobb et al., 1997; Inman et al., 1993). Of these, two that compared low-air-loss beds with a bed and overlay were pooled using random effects (I2 = 26%) (Cobb et al., 1997; Inman et al., 1993). A significant difference in favour of the low-air-loss beds was found (RR 0.33, 95% CI 0.16–0.67). The comparison between low-air-loss hydrotherapy and standard care (Bennett et al., 1998) found that there was a higher pressure ulcer incidence amongst those study participants cared for on a the low-air-loss hydro support surface (19%) compared to those who received standard care (7%) (RR 2.67, 95% CI 0.86–8.27). No significant differences were found between an air-fluidised bed and a dry flotation mattress (Economides et al., 1995). 6. Comparisons between other pressure supports 6.1. Operating table overlays Two trials compared the Micropulse system with a gel pad during surgery and a standard mattress post- operatively (Aronovitch et al., 1999, Russell and Lichten- stein, 2000). These two trials were pooled (fixed effect model I2 = 0%, x2 0.40, df = 1, p = 0.01) and the Micropulse system was found to be significantly better at preventing pressure ulcers (RR 0.21, 95% CI 0.06–0.70). There was a significant reduction in the incidence of
  • 73. post-operative pressure ulcers in participants allocated a dry visco-elastic pad compared to standard care (RR 0.53, 95% CI 0.33–0.85) (Nixon et al., 1998). Schultz et al. (1999) reported a higher incidence of pressure ulcers in patients in the overlay group (26.6%) compared with 16.4% in the standard care group (16.4%). More details about this study was sought from the author but were not forthcoming. The study by Feuchtinger et al. (2006) was terminated because more people in the thermoactive viscoelastic foam overlay group developed pressure ulcers (2 compared to one in the group allocated a water-filled warming mattress without the overlay). 6.2. Kinetic turning tables and profiling beds Using a fixed effect model (I2 = 0%, x2 0.35, df = 1, p = 0.59), there was no evidence of a significant difference between kinetic turning tables compared with conven- tional beds (Gentilello et al., 1988, Summer et al., 1989) (RR 1.23, 95% CI 0.57–2.65). Keogh et al. reported that no pressure ulcers occurred in those cared for on a profiling bed or on a flat-based bed. 6.3. Seat cushions Four trials (Conine et al., 1993, 1994; Geyer et al., 2001; Lim et al., 1988) evaluated the use of seat cushions. No significant differences were found in the two trials that compared slab and contoured foam cushions (Conine et al., 1993; Lim et al., 1988) (RR 1.00, 95% CI 0.84–1.18) and (RR 1.06, 95% 0.75–1.49). Nor were differences found between a pressure redistribution seat cushion compared with a standard cushion (Geyer et al., 2001: RR 0.68, 95% CI 0.33– 1.42) or between a Jay cushion and foam cushion (Conine
  • 74. et al., 1994: RR 0.61, 95% CI 0.37–1.00). 7. Discussion This systematic review shows that a range of foam- based, low pressure mattresses and overlays, sheepskins, and also some ‘higher-tech’ support surfaces are more effective than either standard hospital mattresses or standard care in preventing pressure ulcers. In terms of operating theatre support surfaces, Nixon et al. (1998) found a gel-filled overlay to be significantly better than a standard operating table. However, in two other trials a gel-filled overlay on the operating table was less effective than an alternating pressure overlay (the Micropulse system) intra- and post-operatively (Aronovitch et al., 1999; Russell and Lichtenstein, 2000). However in these two trials it is not clear whether this is the result of better postoperative pressure relief. Two other trials (Feuchtinger et al., 2006; Schultz et al., 1999) reported post-operative skin changes as a result of different operating theatre overlays. However, the clinical importance of these results is difficult to ascertain in the absence of details from the authors such as pressure ulcer grading and comprehensive descriptions of products evaluated. In addition, it is difficult to separate out the role of postoperative care and concomitant interventions; either of which may have caused the skin changes (mainly found on buttock and coccyx). There are indications that two other interventions may also be harmful. Firstly, Foot Waffle heel elevators were associated with a non-significant trebling in the incidence of pressure ulcers in a small trial (Tymec et al., 1997). In another small trial over double the number of those cared for on a low-air-loss hydro support surface developed pressure ulcers compared to those allocated standard care
  • 75. (Bennett et al., 1998). However, neither of these trials provided clear information to indicate that the groups were similar at baseline in relation to the most important prognostic factors. Despite the number of comparisons and different products evaluated there remain gaps in the knowledge base for which a rational research agenda could be developed. For example, air fluidised therapy as a prevention strategy has only been compared with dry flotation, and low-air-loss only with standard care. The results of meta-analyses of trials of sheepskins are sensitive to the outcome measure selected. When analysis is confined to Grade 2 and higher pressure ulcers, any significant reduction in pressure ulcer incidence associated with sheepskin disappears. The results reported in the three studies are based predominantly on Grades 1 and 2 pressure ulcers, so the effects of sheepskins on preventing more severe ulcers is uncertain. The estimates obtained when analysing only Grade 2 and higher pressure ulcers varied whether using a fixed effects (results significant) or random effects (results not significant) model. While there is some evidence that sheepskin reduced overall ulceration incidence, once we sample the evidence using Grade 2 and hig het the act and Gra Fur she Gra
  • 77. rev 200 effe et a 8. C and sur How as pre bee are E. McInnes et al. / International Journal of Nursing Studies 49 (2012) 345–359 357 her pressure ulcers, the power is reduced and the erogeneity means that we cannot be fully confident of results. It can be postulated that the likely mode of ion of sheepskin will reduce friction but not pressure therefore would be likely to impact on the incidence of de 2 ulcers but not on more severe pressure damage. ther evaluations are therefore required of medical epskins of sufficient power to identify an effect on de 2 ulcer incidence versus Grade 3 and higher. Strengths and limitations Generally, the risk of bias in the included trials was h. While recent trials have improved reporting of some dy details, common methodological flaws included lack llocation concealment, lack of baseline comparability, h attrition rates, lack of intention to treat analysis, lack
  • 78. blind or independently verified outcome assessment. s than half of the trials included sample size estimates small sample size was a limitation in many. Other flaws include failure to report on pressure ulcer us on study entry. In many trials the definitions of ssure ulcer free’, ‘low-risk’, ‘moderate-risk’ and ‘high- ’ varied widely and in some trials we were unable to ertain whether study participants with Grade 1 ulcers re accepted into the sample and included in the lyses. ‘Standard care’ was poorly described in many ls and clear descriptions of interventions were also n lacking. Many of the trials reviewed did not provide rmation about co-interventions, such as repositioning, whether these were provided equally to each study . In terms of publication bias, it is important to note that ny of the published trials identified had received some ding from manufacturers. It is also important for the der to be aware that in the older trials the materials d in the production of support surfaces may no longer used. The strengths of our systematic review are the rigorous rching and sifting methods, double data extraction and ble assessment of risk of bias using a standardised tool that we made attempts to contact study authors to ain additional information when needed. Our findings also consistent with a systematic review of RCT’s and si-randomised trials investigating the prevention of l pressure ulcers (Junkin and Gray, 2009) a systematic iew on general pressure ulcer prevention (Reddy et al.,
  • 79. 6) and a review of three trials investigating the ctiveness of Australian Medical Sheepskins (Mistiaen l., 2010). onclusion A range of products such as low pressure mattresses overlays, sheepskins, and some ‘higher-tech’ support faces are effective at preventing pressure ulcers. ever, the relative merits of some interventions such higher-tech constant low pressure and alternating ssure remain unclear. The use of seat cushions has not n adequately evaluated and the findings of some trials trials should address the deficiencies discussed above while adhering to the CONSORT statement and also collect data on aspects of equipment performance such as reliability. Conflict of interest None declared. References Allman, R.M., 1997. Pressure ulcer prevalence, incidence, risk factors, and impact. Clinical Geriatric Medicine 13 (3), 421–436. Andersen, K.E., Jensen, O., Kvorning, S.A., Bach, E., 1982. Decubitus pro- phylaxis: a prospective trial on the efficiency of alternating pressure air mattresses and water mattresses. Acta Dermato- Venereologica
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  • 96. the incidence of pressure ulcers. Applied Nursing Research 10 (3), 111–120. Whitney, J.D., Fellows, B.J., Larson, E., 1984. Do mattresses make a difference? Journal of Gerontological Nursing 10 (9), 20–25. Woodbury, M., Houghton, P., 2004. Prevalence of pressure ulcers in Canadian healthcare settings. Ostomy/Wound Management 50 (10) pp. 22–24, 26, 28, 30, 32, 34, 36–28. http://www.sign.ac.uk/methodology/filters.html http://www.sign.ac.uk/methodology/filters.htmlPreventing pressure ulcers-Are pressure-redistributing support surfaces effective? A Cochrane systematic review and meta- analysisIntroductionMethodsResultsComparisons: ‘low-tech’ constant low pressure support surfacesComparisons between ‘low-tech’ constant low pressure support surfaces and standard foam surfacesComparisons between alternative foam support surfacesOther ‘low-tech’ support surfaces with various comparisonsComparisons: ‘high-tech’ pressure support surfacesComparisons between alternating pressure supports and standard hospital mattressComparisons between alternating pressure supports and constant low pressure supportsComparisons between different alternating pressure devicesLow-air-loss and air-fluidised bedsComparisons between other pressure supportsOperating table overlaysKinetic turning tables and profiling bedsSeat cushionsDiscussionStrengths and limitationsConclusionReferences