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Burn-care in Practice
The necessity for hand therapy interventions for patients with partial
thickness isolated hand/forearm burns: A randomized controlled pilot
trial
Bradley J. Schmitt a,⇑
, Kathy Stiller b
, Kathryn E. Heath a
, Tanja Klotz a
, John E. Greenwood a
a
Adult Burns Service, Royal Adelaide Hospital, Australia
b
Central Adelaide Local Health Network, Australia
a r t i c l e i n f o
Article history:
Received 30 April 2018
Received in revised form 10 September
2018
Accepted 10 September 2018
Available online 15 September 2018
Keywords:
Burns
Skin
Artificial
Physical therapy modalities
Hand
Injuries
a b s t r a c t
Objective: The recovery of patients with partial thickness isolated hand burns managed with an epider-
mal skin substitute appears to be rapid and the necessity for routine hand therapy interventions in this
setting is unknown. This study investigated the need for hand therapy for these patients.
Methods: A randomized controlled trial was undertaken. The Treatment Group received routine hand
therapy provided by a physiotherapist, including assessment, daily range of motion exercises, education
and, if required, edema management and outpatient physiotherapy follow-up. Control Group participants
received no hand therapy input. Outcomes included the Michigan Hand Questionnaire (baseline, 1, 2,
4 weeks and 3 months post-injury), finger total active motion, wrist range, grip strength (1, 2 and
4 weeks) and participant satisfaction (4 weeks).
Results: Twenty-nine participants were recruited over a 2.3 year period. All outcomes significantly
improved over time (p  0.008). No significant between-group differences were observed for any out-
come except the pain subscale of the Michigan Hand Questionnaire. Participants with deeper burns
had significantly poorer outcomes for some Michigan Hand Questionnaire data. Study limitations
included a small sample size, heterogeneity and some loss to follow-up.
Conclusions: While the provision of routine hand therapy interventions for patients with partial thickness
isolated hand/forearm burns that were managed with an epidermal skin substitute did not appear to be
of benefit, study limitations means these results cannot be extrapolated and reinforces the need for
further research. Routine hand therapy input may be of benefit for those with deeper burns.
Ó 2018 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license
(http://creativecommons.org/licenses/by-nc-nd/4.0/).
1. Introduction
Burn injuries result in only a small fraction (1%) of hospitaliza-
tions but can have major consequences on those affected in terms
of their quality of life and return to functional activities [1]. The
hand is particularly susceptible to burn injury, occurring in up to
90 percent of those with major burn injuries and, despite involving
only a relatively small area, hand burns can have a major impact on
function, appearance and quality of life [2–4].
The management of hand burns varies according to the severity
of the burn injury and may include conservative management
(when presentation is delayed or the burns are very small in area)
where natural recovery and spontaneous healing is allowed, the
application of epidermal skin substitutes (e.g. BiobraneÒ
,
AWBATTM
, SuprathelÒ
) if the burns are acute and superficial,
through to excision and split skin grafting of deep burns. A
prospective audit undertaken at our burns unit by Williams et al.
[5], where the outcomes of 52 patients with isolated hand burns
were reviewed, found that patients with superficial or partial
thickness burns had rapid recovery in range, grip strength and
hand function, with normal or near-normal values achieved within
2–4 weeks post-injury. In contrast, those patients with full thick-
ness burns requiring split skin grafting demonstrated more marked
initial deterioration, a slower rate of improvement, but eventually
good recovery by 12 months. All patients included in this study
received standard assessment and interventions by nursing and
allied health staff which, from a hand therapy perspective,
included early assessment, daily range of motion (ROM) exercises
that were supervised/assisted by a physiotherapist, education
and, as required, edema management, scar management and
https://doi.org/10.1016/j.burnso.2018.09.001
2468-9122/Ó 2018 The Authors. Published by Elsevier Ltd.
This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
⇑ Corresponding author at: 7G-170, Royal Adelaide Hospital, Port Road, Adelaide,
South Australia 5000, Australia.
E-mail address: Brad.Schmitt@sa.gov.au (B.J. Schmitt).
Burns Open 2 (2018) 171–177
Contents lists available at ScienceDirect
Burns Open
journal homepage: www.burnsopen.com
outpatient physiotherapy follow-up [5]. Whilst these hand therapy
interventions appear extensive, our clinical experience, both dur-
ing this study and since, is that the majority of patients with partial
thickness burns that are able to be managed with an epidermal
skin substitute require relatively few hand therapy interventions:
after an initial assessment and provision of ROM exercises, most
patients recover quickly and only require brief re-assessment
thereafter.
Given that the recovery of patients with superficial or partial
thickness isolated hand burns, that were able to be managed con-
servatively or with epidermal skin substitute application, was
rapid and the amount of hand therapy required was low, it raises
the question of whether any routine hand therapy interventions
are required for these patients. In a healthcare setting where
resources (e.g. time, staffing) are limited, the ability to focus hand
therapy interventions on those patients who require them is essen-
tial. Therefore, the aim of this study was to compare standard hand
therapy interventions to no hand therapy interventions for
patients with partial thickness isolated hand/forearm burns that
were managed with application of an epidermal skin substitute.
2. Methods
2.1. Design
A randomized controlled trial with intention-to-treat analysis,
assessor blinding and concealed allocation was undertaken. The
study was approved by the Royal Adelaide Hospital Research Ethics
Committee and registered with the Australian New Zealand Clini-
cal Trials Registry (ACTRN 12614000401651).
2.2. Setting and participants
The study was undertaken at the Royal Adelaide Hospital, a
650-bed, tertiary-care, urban, public hospital in Australia from July
2014 until November 2016. The Royal Adelaide Hospital Adult
Burns Service admits approximately 450 patients per year.
Potential participants were adults (18 years) admitted to the
Royal Adelaide Hospital Adult Burns Service for management of a
partial thickness isolated unilateral hand/forearm burn that was
managed with the application of an epidermal skin substitute.
For the purposes of this study, an isolated hand/forearm burn
was defined as a burn affecting the hand alone or the hand and
extending into the distal third of the forearm. Exclusion criteria
were: unwillingness to participate; inability to understand writ-
ten/spoken English, other concomitant major injuries (e.g. major
bony fracture) or a pre-existing condition (e.g. tetraplegia, paraple-
gia) that could adversely affect outcomes, inability to return for
follow-up appointments, or that the circumstances of the burn
injury were considered so traumatic that a request to consider par-
ticipating in the study was deemed inappropriate (e.g. self-inflicted
burn injury or where another person had died).
2.3. Study protocol
Patients were recruited by the principal investigator (BS) and
after providing informed written consent were randomly allocated
to a treatment or control group using randomly permuted blocks of
four. The randomization schedule was generated by an indepen-
dent statistician using the ralloc command in Stata version 13,
with group allocation stored on a password-protected spreadsheet
and revealed by an independent staff member not otherwise
involved in the study.
All participants received usual medical and nursing care as clin-
ically indicated. In our burns unit, physiotherapists routinely pro-
vide hand therapy interventions with occupational therapists
providing scar management if required. All participants received
the epidermal skin substitute (BiobraneÒ
) which was applied
under general anesthetic within 48 h of burn injury and the
affected area immobilized with a boxing glove dressing for 2–
3 days. Hospital discharge usually occurred between day 1–3
post-application of the skin substitute. Patients returned to out-
patients for burn assessment and dressing changes by nursing staff
twice a week until the skin substitute was removed, which was
2 weeks post-burn injury. This out-patient follow-up continued
until the burn was healed and/or full hand function had been
achieved, which usually ranged from 10 days to 4 weeks.
Treatment Group participants received hand therapy interven-
tions from a physiotherapist as per our usual clinical practice. This
comprised: assessment, education, provision and supervision of
exercises for the non-affected joints in the affected limb on the first
day after application of the epidermal skin substitute; daily provi-
sion, supervision and assistance during hospital admission of ROM
exercises for the affected joints once cleared for movement by the
burns surgeon (usually day 2 or 3 post-application [which may
have occurred post-hospital discharge]); provision of a patient
education pamphlet detailing these exercises; provision of an off-
the-shelf compression glove or elasticated tubular bandage (i.e.
TubigripÒ
) as required; assessment/interventions for follow-up
out-patient physiotherapy as required. Control Group participants
received no hand therapy assessment or interventions from a
physiotherapist and did not receive the patient education pam-
phlet. All participants received assessment/interventions for scar
management (from an occupational therapist) if required (usually
after 2 weeks).
Any participant who failed to improve, primarily based but not
restricted to a total Michigan Hand Questionnaire (MHQ) score
50 at 2 weeks, received hand therapy assessment and interven-
tions as required, irrespective of their group allocation. Their data
were included in analyses. This MHQ cut-off score was based on
data reported by Williams et al. [5] where the mean (standard
deviation [SD]) value for patients with partial thickness isolated
hand burns and managed with an epidermal skin substitute was
70 (21) at 2 weeks and thus a score of 50 was approximately equal
to the mean value minus one SD.
Medical, nursing and occupational therapy staff were not
informed of group allocation.
2.4. Outcomes
The primary outcome was the MHQ which is a hand-specific
instrument comprising 37 core questions measuring outcomes of
patients with conditions or injuries (including burns) to the hand
or wrist [6–9]. It has six scales (overall hand function, single-
handed activities of daily living [ADL], work performance, pain,
aesthetics, and patient satisfaction with hand function), with an
optional extra scale evaluating the ability to undertake two-
handed ADL. Each item has five possible responses (ranging, for
example, from 1 = not at all difficult to 5 = very difficult), and the
raw scores for each scale are converted to a score ranging from 0
to 100. For the pain scale, a higher score indicates greater pain,
whereas for the other five scales higher scores indicate better hand
performance. An overall score (0–100) can also be calculated. The
MHQ is easy to administer, can be self-administered or adminis-
tered by research personnel, takes approximately 15 min to com-
plete and has been shown to be responsive to change with good
psychometric properties, albeit in non-burn injured populations
[5–7]. During the current study, the MHQ was completed by the
participant. If a participant failed to attend an out-patient appoint-
ment, the MHQ was emailed or posted for them to complete inde-
pendently and return via email or in a reply-paid envelope.
172 B.J. Schmitt et al. / Burns Open 2 (2018) 171–177
Active ROM of the hand was measured using a finger goniome-
ter, with the patient simultaneously flexing all finger joints maxi-
mally. The sum of flexion at all joints (metacarpophalangeal,
proximal interphalangeal and distal interphalangeal joints) minus
the sum of any extension deficit at these joints was added to give
total active motion (TAM). This approach provides one functional
composite ROM for each digit (not including the thumb). A mean
TAM was then calculated for the affected hand [10,11]. TAM has
been used extensively in studies evaluating outcomes after hand
injuries, including burn injury, and is quick and easy to use
[5,11–13]. Active wrist ROM (flexion and extension) was also mea-
sured. All ROM measurements were performed using a goniometer
in positions recommended by the American Society of Hand Ther-
apists [14].
Grip strength was used as a global assessment of hand strength
and measured using a calibrated Jamar dynamometer (JA Preston
Corporation, Jackson, MI) on setting two to ensure maximal grip
strength, as per the American Society of Hand Therapist guidelines
[15]. Given the study sample (i.e. hand burns) and the acuity of the
burn injury, we elected to record a single maximal attempt at grip
strength [16] even though the validity of doing this has not been
specifically evaluated in hand burns patients. Grip strength is quick
and easy to perform, reliable when performed in a standardized
fashion [17], reliable and valid in strength assessment for patients
with minor burns [18] and has been previously used as an outcome
measure for patients with burn injuries [5,10,19].
Based on the results of our previous research, MHQ, ROM and
grip strength were recorded for all participants at weeks 1, 2 and
4 post-application of the skin substitute [5]. The MHQ was also
measured for all participants at admission to hospital (with partic-
ipants asked to respond as they were prior to their burn injury) and
at 3 months post-burn injury.
Other outcome data collected included the number and type of
hand therapy interventions from a physiotherapist (Treatment
Group), number of participants requiring occupational therapy
intervention for scar management, and participants’ rating of their
satisfaction with their allocated group intervention (rated at
4 weeks post-injury using a simple verbal analogue scale where
0 = not at all satisfied and 10 = completely satisfied).
The therapist-rated outcomes (i.e. ROM, grip strength) were
measured by a blinded assessor (KH, TK). A training session for
assessors was held before commencement of data collection to
ensure measurements were performed in a standardized manner.
Participants were instructed not to discuss any aspect of the trial
with the assessor to aid maintenance of blinding.
Background data for each participant were collected from med-
ical records and/or personal interview by one of the investigators.
These data included gender, age, past medical history (focussing on
conditions potentially impacting on hand function [e.g. alcohol/
drug use, chronic pain]), handedness, percentage of total body
surface area (TBSA) burned, length of hospital stay and hospital
complications. We also recorded whether the epidermal skin sub-
stitute application was categorized at the time by the treating
burns surgeon as being ‘trial of life’, meaning that the depth of
the burn was deep partial thickness and thus on the borderline
of being able to be managed with an epidermal skin substitute or
necessitating split skin grafting. Time to epithelialization data were
also retrieved from out-patient records.
2.5. Data analyses
Demographic and clinical characteristics of participants were
compared between groups using Chi Square tests and independent
samples t tests for categorical and interval data respectively.
Differences over time and between groups for outcome measures
were analysed using repeated measures analysis of variance
(RM ANOVA). Analyses were conducted on an intention-to-treat
basis, using all available data from randomized participants.
Analyses were performed using SPSS. P values 0.05 were consid-
ered significant.
3. Results
3.1. Study participants
A total of 52 patients were admitted to the Royal Adelaide
Hospital Adult Burns Service for management of a partial thickness
isolated unilateral hand/forearm burn that was managed with the
application of an epidermal skin substitute and thus were screened
for eligibility (Fig. 1). Of these, 29 (56%) met the inclusion criteria
and were randomized. No participants were withdrawn from the
study because of the need for skin grafting. The main reason for
exclusion was an inability to return for follow-up due to residing
in a rural area (Fig. 1). Baseline demographic and admission details
were similar for the two groups (Table 1).
3.2. Compliance with trial
Hand therapy interventions for the Treatment Group were pro-
vided by a physiotherapist as scheduled on 100% of occasions. The
mean (range) total number of physiotherapy visits for the Treat-
ment Group was 4.1 (3–6), with 1.5 (1–2) and 2.7 (1–4) visits pro-
vided as an in-patient and out-patient respectively. The mean
(range) total physiotherapy time per Treatment Group participant
was 116.0 (70–190) min, with 46.3 (20–80) and 69.7 (40–130) min
provided as an in-patient and out-patient respectively. All 15 par-
ticipants in the Treatment Group received assessment, education,
exercises for the affected joints and non-affected ipsilateral joints.
Of the 15 Treatment Group participants, 11 (73%) received an
off-the-shelf compression glove and 3 (20%) were provided with
TubigripÒ
for edema control. No adverse effects resulting from
these physiotherapy interventions were reported.
For the 29 randomized participants, MHQ data were obtained at
baseline, weeks 1, 2, 4 weeks and 3 months for 29 (100%),
29 (100%), 29 (100%), 23 (79%) and 16 (55%) participants respec-
tively. Data for TAM, wrist range of motion and grip strength were
obtained at weeks 1, 2 and 4 for 29 (100%), 28 (97%) and 19 (65%)
participants respectively. Patient satisfaction data were obtained
for 16 (55%) participants. The breakdown of these data by group
allocation can be found in Table 2.
The therapists who acted as independent assessors reported no
episodes of unblinding.
3.3. Main results
Outcome data are summarized in Table 2. There was an
improvement in all outcomes over time, with this improvement
significant for all outcomes. No significant group effect was seen
for any outcome except MHQ pain. No group effect was seen for
patient satisfaction measured at 4 weeks. In total, six participants
(Treatment Group = 5, Control Group = 1) received occupational
therapy intervention, in all cases for scar management (p = 0.082).
In total, 5 (30%) Treatment Group participants and 3 (21%)
Control Group participants (p = 0.474) had a MHQ total score 50
at 2 weeks and thus received hand therapy assessment and inter-
ventions as required, irrespective of their group allocation. As the
5 Treatment Group participants with a low MHQ total score were
already receiving hand therapy, this therapy continued essentially
unchanged. The 3 Control Group participants with a low MHQ total
score received, as a result of their low MHQ total score, a one-off
hand therapy assessment/interventions at 2 weeks but
B.J. Schmitt et al. / Burns Open 2 (2018) 171–177 173
unfortunately all 3 failed to attend further appointments and were
lost to follow-up at both 1 and 3 months.
3.4. Other influencing factors
We reviewed our data for other clinical factors that may have
affected outcomes (e.g. burn depth [trial of life], whether the burn
injury involved the dominant or non-dominant side). As noted in
Table 1, 4 (27%) and 2 (14%) participants in the Treatment and
Control Groups respectively had deep partial thickness burns and
thus received the epidermal skin substitute as a trial of life. We
also compared time to epithelialization between those participants
with deep partial thickness burns (i.e. trial of life; n = 6) to those
with partial thickness burns (n = 23), finding a significantly longer
time to healing for those with deeper burns (means [SDs] =
31.2 [8.8] and 16.2 [6.8] days respectively; p = 0.000), suggesting
the categorization of burn depth at the time of the burn injury
was accurate.
RM ANOVA, using burn depth (trial of life) as a co-variant
(in addition to group allocation), revealed that this had a signifi-
cant effect on the following outcomes: MHQ total (p = 0.019),
MHQ overall function (p = 0.030), MHQ ADLs single-handed
(p = 0.000), MHQ patient satisfaction (p = 0.033) and MHQ ADLs
two-handed (p = 0.006) and, in all instances was associated with
poorer outcomes. No significant effect was seen for group alloca-
tion whereas, with the exception of MHQ appearance, a significant
effect was seen for time. Even for those outcomes where signifi-
cance was not achieved, outcomes were poorer for those with deep
partial thickness burns where the skin substitute was categorized
as a trial of life compared to those who were not. Burn depth
(i.e. trial of life) also seemed to influence the proportion of partic-
ipants with a MHQ total score 50 at 2 weeks (3 of 8 participants
[37.5%] with a low MHQ total score compared to 3 of 21 [14.3%] for
those without a low MHQ total score). We also compared the hand
therapy input by a physiotherapist for Treatment Group partici-
pants according to burn depth (trial of life), finding that the mean
(SD) total physiotherapy time was significantly greater for the
Fig. 1. Design and flow of participants through the trial.
174 B.J. Schmitt et al. / Burns Open 2 (2018) 171–177
4 participants where epidermal skin substitute application was
categorized as being trial of life compared to the 11 other partici-
pants (155.0 [35.8] vs 101.8 [25.7] min respectively, p = 0.007).
Four of the 6 participants (67%) who received the skin substitute
application as a trial of life required scar management intervention
from occupational therapists once healing had occurred, compared
to 2 of 23 participants (9%) where it was not classified as a trial of
life. Hand dominance did not have a significant effect on outcomes.
In view of the significant influence that burn depth (trial of life)
had on MHQ outcomes, we also analyzed our outcome data sepa-
rating our sample according to depth of burn (i.e. partial thickness
burns or deep partial thickness burns [where the skin substitute
was categorized as a trial of life]) and then compared intervention
groups (RM ANOVA) within each sub-group. In summary, for the
partial thickness burns sub-group, no significant difference was
seen between intervention groups for any outcome (p  0.106).
Similarly, for the deep partial thickness burns sub-group, where
the number of participants available for analyses was low, no
significant difference was seen between intervention groups
(p  0.094).
4. Discussion
This randomized, controlled, single-blinded trial compared the
effectiveness of standard hand therapy treatment to no hand ther-
apy treatment for patients with partial thickness isolated hand/-
forearm burns that were managed with an epidermal skin
substitute. Significant improvements in all outcomes were seen
over time, but no significant differences between groups were
detected except for MHQ pain. Deep partial thickness burns, where
the application of the skin substitute was classified as a trial of life,
was associated with significantly poorer outcomes for some MHQ
data. However, given the nature of our study, with a relatively
small sample, some heterogeneity and loss to follow-up (especially
after 4 weeks), these results cannot be extrapolated and further
research is required.
Our results were similar to those of Williams et al with respect
to MHQ data, although grip strength in our study (means of 30
and 32 kg at 2 and 4 weeks) was lower than that reported by Wil-
liams et al (medians of 41 and 46 kg at 2 and 4 weeks), most likely
reflecting the greater proportion of males in their sample [5]. Also
similar to Williams et al, we found that patients with deeper hand
burn injuries (i.e. deep partial thickness) had slower recovery of
hand function [5]. Other studies have also reported a slower recov-
ery of hand function for deeper hand burn injuries [20–22]. Inter-
estingly, length of hospital stay for patients reduced from a mean
of 4 days in the study by Williams et al to 2 days in the current
study, which most likely reflects recent clinical practice whereby
earlier discharge is sought [5]. Our results for MHQ, which was
the only outcome measure where we were able to obtain a quasi
pre-injury measurement, showed a steady increase over time and
return to near baseline values at 3 months for all MHQ scales
except aesthetics. We believe these results reflect acceptable
recovery.
Our findings are important as this study is one of the first, if not
the first, randomized controlled trial evaluating the effectiveness of
hand therapy after burn injury. Other strengths of our study
include the wide range of outcome measures used, covering both
therapist-measured and patient-reported outcomes and including
measures of function and satisfaction. The significant improve-
ments seen over time using these outcome measures reflects their
Table 1
Demographic and clinical characteristics of participants by treatment group.
Treatment Group
n = 15
Control Group
n = 14
P values*
Gender, n (%)
Male 8 (53) 9 (64) 0.413
Female 7 (47) 5 (36)
Age, years, mean (SD) 35.5 (17.4) 43.2 (12.4) 0.186
Past medical history, yes, n (%)
Alcohol/drug 5 (33) 1 (7) 0.082
Smoker 3 (20) 3 (21) 0.924
Diabetes 1 (7) 0 (0) 0.326
Previous hand/wrist injury 0 (0) 2 (14) 0.129
Mechanism of burn injury, n (%)
Scald 8 (53) 7 (50) 0.674
Flame 3 (20) 5 (36)
Flash 1 (7) 1 (7)
Contact 3 (20) 1 (7)
TBSA, mean (SD) 1.5 (1.0) 1.6 (0.7) 0.768
Affected hand, n (%)
Dominant 9 (60) 9 (64) 0.812
Non-dominant 6 (40) 5 (36)
Area burnt, n (%)
Fingers 9 (60) 13 (93) 0.039
Palmar hand 1 (7) 3 (21) 0.249
Dorsum hand 12 (80) 9 (64) 0.344
Forearm 9 (60) 9 (64) 0.812
Depth of burn, n (%)
Superficial partial thickness/mid dermal 11 (73) 12 (86) 0.651
Deep partial thickness (trial of life) 4 (27) 2 (14)
Hospital length of stay, days, mean (SD) 2.9 (1.4) 2.1 (0.6) 0.055
SD, standard deviation; TBSA, total body surface area.
*
Categorical data were compared using Chi Square analyses: for those data where only one response was possible one Chi Square
result has been provided, whereas for those data where multiple responses were possible Chi Square analyses were done for each
response (i.e. comparing the number of yes/no responses). Interval data were compared using Independent Samples t tests.
B.J. Schmitt et al. / Burns Open 2 (2018) 171–177 175
Table 2
Outcome data of participants by treatment group.
Treatment Group
n = 15
Mean (SD) [n]
Control Group
n = 14
Mean (SD) [n]
P values*
MHQ total (0–100)
Admission (baseline) 99.0 (2.5) [15] 96.4 (6.1) [14] 0.000 time
1 week 38.8 (18.4) [15] 46.4 (19.5) [14] 0.131 group
2 weeks 62.8 (20.7) [15] 67.8 (22.8) [14]
4 weeks 76.5 (15.1) [13] 89.6 (11.5) [10]
3 months 95.1 (3.0) [9] 95.1 (3.2) [7]
MHQ overall hand function
Admission (baseline) 99.0 (2.1) [15] 93.8 (9.2) [14] 0.000 time
1 week 42.3 (19.4) [15] 53.9 (19.8) [14] 0.402 group
2 weeks 70.3 (22.9) [15] 70.4 (20.0) [14]
4 weeks 85.0 (14.7) [13] 88.0 (14.0) [10]
3 months 94.4 (9.2) [9] 95.7 (7.3) [7]
MHQ ADLs (single-handed)
Admission (baseline) 99.3 (1.8) [15] 95.0 (9.8) [14] 0.000 time
1 week 33.0 (30.3) [15] 35.4 (25.9) [14] 0.621 group
2 weeks 67.7 (32.9) [15] 74.3 (20.7) [14]
4 weeks 88.5 (12.8) [13] 93.5 (7.8) [10]
3 months 99.4 (1.7) [9] 96.1 (6.1) [7]
MHQ work performance
Admission (baseline) 99.0 (2.8) [15] 94.6 (11.7) [14] 0.000 time
1 week 35.7 (38.8) [15] 30.4 (29.4) [14] 0.190 group
2 weeks 43.3 (36.9) [15] 56.8 (35.6) [14]
4 weeks 59.2 (31.7) [13] 88.0 (27.9) [10]
3 months 96.7 (7.1) [9] 98.6 (3.8) [7]
MHQ pain
Admission (baseline) 0.7 (2.6) [15] 3.2 (8.2) [14] 0.000 time
1 week 61.3 (20.1) [15] 48.9 (25.4) [14] 0.038 group
2 weeks 31.7 (23.8) [15] 26.1 (25.3) [14]
4 weeks 17.7 (15.8) [13] 8.5 (14.5) [10]
3 months 0.0 (0.0) [9] 0.0 (0.0) [7]
MHQ aesthetics
Admission (baseline) 97.5 (9.7) [15] 98.2 (4.5) [14] 0.000 time
1 week 43.3 (28.5) [15] 56.8 (23.2) [14] 0.070 group
2 weeks 49.2 (27.5) [15] 63.4 (26.3) [14]
4 weeks 56.7 (28.7) [13] 83.1 (17.9) [10]
3 months 77.8 (21.7) [9] 80.4 (22.9) [7]
MHQ patient satisfaction
Admission (baseline) 99.4 (1.5) [15] 98.2 (4.6) [14] 0.000 time
1 week 38.1 (30.3) [15] 47.0 (24.6) [14] 0.646 group
2 weeks 72.5 (25.1) [15] 67.6 (30.8) [14]
4 weeks 86.5 (14.6) [13] 92.9 (9.6) [10]
3 months 99.5 (1.4) [9] 98.2 (3.3) [7]
MHQ ADLs (two-handed)
Admission (baseline) 99.7 (1.0) [15] 98.0 (5.0) [14] 0.000 time
1 week 36.9 (29.0) [15] 43.4 (27.7) [14] 0.710 group
2 weeks 68.8 (29.6) [15] 75.5 (23.9) [14]
4 weeks 85.2 (18.0) [13] 94.3 (10.9) [10]
3 months 99.6 (1.2) [9] 99.0 (1.8) [7]
Total active motion (degrees)
1 week 226.5 (77.9) [15] 213.2 (31.9) [14] 0.008 time
2 weeks 265.4 (34.6) [15] 250.1 (29.1) [13] 0.772 group
1 month 285.9 (25.4) [12] 257.7 (30.3) [7]
Wrist extension
1 week 57.7 (13.9) [15] 51.1 (24.9) [14] 0.005 time
2 weeks 65.5 (9.2) [15] 60.9 (17.2) [13] 0.731 group
1 month 69.8 (10.2) [12] 61.6 (13.3) [7]
Wrist flexion
1 week 66.3 (9.8) [15] 53.6 (17.0) [14] 0.001 time
2 weeks 78.2 (8.9) [15] 66.1 (15.5) [13] 0.786 group
1 month 80.6 (8.8) [12] 65.3 (13.4) [7]
Grip strength (kg)
1 week 20.8 (13.8) [15] 23.5 (13.0) [14] 0.000 time
2 weeks 28.9 (10.2) [15] 31.3 (11.4) [13] 0.712 group
1 month 32.3 (10.2) [12] 33.0 (11.6) [7]
Patient satisfaction (VAS) 9.6 (0.5) [10] 7.5 (3.3) [6] 0.167
ADLs, activities of daily living; MHQ, Michigan Hand Questionnaire; VAS, verbal analogue scale.
*
P values are shown for the effect of time and group allocation.
176 B.J. Schmitt et al. / Burns Open 2 (2018) 171–177
sensitivity for this cohort. One of the main limitations of our study
was the relatively small sample size despite recruitment lasting
2 years due to our tight inclusion criteria. Another main limitation
was that despite our best attempts to recruit a homogenous sam-
ple (by limiting recruitment to patients admitted with partial
thickness isolated hand burns that were managed with an epider-
mal skin substitute), our sample still exhibited some heterogeneity
(e.g. burn depth), which in turn impacted on outcomes. These lim-
itations highlight the difficulty of conducting research in a burns
population. Our study was single-site only and, because of the need
to return for follow-up, most patients recruited to the study
resided in a metropolitan area, which could potentially have influ-
enced our results. Our choice of using the MHQ as our main out-
come measure could be questioned, however we chose it given
our previous positive experience of using it with a similar patient
population [5], even though its psychometric properties have not
been formally measured in this setting. Our decision to record a
single maximal attempt at grip strength could also be questioned
and means we were unable to quantify any learned effect for this
outcome. There was some loss to follow-up over time, particularly
the 3 month MHQ data and the therapist-rated outcomes, however
retention up to 4 weeks was reasonably good. It is also acknowl-
edged that whilst therapist-rated outcomes were measured by
blinded assessors, nursing and medical staff may have become
aware of participants’ group allocation. Nursing staff may also have
encouraged hand movement and function as part of their routine
clinical practice.
Further research is required to confirm and extend the results of
this study. In particular, randomized, controlled trials with larger
sample sizes would be beneficial and multi-centred trials would
allow the results to be more generalizable. Similar randomized
controlled trials could be undertaken with other smaller TBSA
burns and with different management protocols.
In conclusion, this randomized, controlled, single-blinded trial
involving patients with isolated hand/forearm burns that were
managed with the application of an epidermal skin substitute,
found no significant difference between those who did or did not
receive routine hand therapy, whereas routine hand therapy may
be of benefit for those with deep partial thickness burns. However,
the limitations of our study means these results cannot be extrap-
olated and further research with larger samples is required to con-
firm and extend our findings.
Conflicts of interest and source of funding
None declared.
References
[1] AIHW: Pointer S, Tovell A. 2016. Hospitalised burn injuries, Australia, 2013-14.
Canberra: AIHW. https://www.aihw.gov.au/reports/injury/hospitalised-burn-
injuries-australia-2013-14. (Accessed Oct 2017). Injury research and statistics
series no.102. Cat. No. INJCAT 178.
[2] Cowan AC, Stegink-Jansen CW. Rehabilitation of hand burn injuries: current
updates. Injury 2013;44:391–6.
[3] Richards WT, Vergara E, Dalaly DG, Coady-Fariborzian L, Mozingo DW. Acute
surgical management of hand burns. J Hand Surg Am 2014;39:2075–85.
[4] Williams T, Berenz T. Postburn upper extremity occupational therapy. Hand
Clin 2017;33:293–304.
[5] Williams N, Stiller K, Greenwood J, Calvert P, Masters M, Kavanagh S. Physical
and quality of life outcomes of patients with isolated hand burns – a
prospective audit. J Burn Care Res 2012;33:188–98.
[6] Chung KC, Pillsbury MS, Walters MR, Hayward RA. Reliability and validity
testing of the Michigan Hand Outcomes Questionnaire. J Hand Surg Am
1998;23:575–87.
[7] Chung KC, Hamill JB, Walters MR, Hayward RA. The Michigan Hand Outcomes
Questionnaire (MHQ): assessment of responsiveness to clinical change. Ann
Plast Surg 1999;42:619–22.
[8] Medical School University of Michigan, MHQ Michigan Hand Outcomes
Questionnaire; available from http://mhq.lab.medicine.umich.edu/home.
Accessed October 9, 2017.
[9] Umraw N, Chan Y, Gomez M, Cartotto RC, Fish JS. Effective hand function
assessment after burn injuries. J Burn Care Rehabil 2004;25:134–9.
[10] Barillo DJ, Harvey KD, Hobbs CL, Mozingo DW, Cioffi WG, Pruitt Jr BA.
Prospective outcome analysis of a protocol for the surgical and rehabilitative
management of burns to the hands. Plast Reconstr Surg 1997;100:1442–51.
[11] Richards R, Parry IS, Santos A, Dewey WS. Burn hand or finger goniometric
measurements: sum of the isolate parts and the composite whole. J Burn Care
Res 2017;38:e960–5.
[12] Johnson C, Engrav LH, Heimbach DM, Marvin JA. Evaluating functional hand
results after deep dermal bums with total active motion measurements. J Burn
Care Res 1980;1:19–21.
[13] Holavanahalli RK, Helm PA, Gorman AR, Kowalske KJ. Outcomes after deep
full-thickness hand burns. Arch Phys Med Rehabil 2007;88:S30–5.
[14] Adams LS, Green LW, Topoozian E. Range of motion. In: Clinical assessment
recommendations. Chicago, IL: American Society of Hand Therapists; 1992. p.
55–69.
[15] Firrell JC. Which settings of the dynamometer provides the maximal grip
strength? J Hand Surg Am 1996;21A:397–401.
[16] Coldham F, Lewis J, Lee H. The reliability of one vs three grip trials in
symptomatic and asymptomatic subjects. J Hand Ther 2006;19:318–27.
[17] Innes E. Handgrip strength testing: a review of the literature. Aust Occup Ther J
1999;46:120–40.
[18] Gittings P, Salet M, Burrows S, Ruettermann M, Wood FM, Edgar D. Grip and
muscle strength dynamometry are reliable and valid in patients with unhealed
minor burn wounds. J Burn Care Res 2016;37:388–96.
[19] Jarrett M, McMahon M, Stiller K. Physical outcomes of patients with burn
injuries - a 12 month follow-up. J Burn Care Res 2008;29:975–84.
[20] Schneider JC, Holavanahalli R, Helm P, O’Neil C, Goldstein R, Kowalske K.
Contractures in burn injury part II: investigating joints of the hand. J Burn Care
Res 2008;29:606–13.
[21] Sheridan RL, Hurly J, Smith MA, Ryan CM, Bondoc CC, Quinby WC, et al. The
acutely burned hand: management and outcome based on a ten-year
experience with 1047 acute hand burns. J Trauma 1995;38:406–11.
[22] van Zuijlen PPM, Kreis RW, Vloemans AFPM, Groenevelt F, Mackie DP. The
prognostic factors regarding long-term functional outcome of full-thickness
hand burns. Burns 1999;25:709–14.
B.J. Schmitt et al. / Burns Open 2 (2018) 171–177 177

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Pengaruh intrapartum Perawatan Pendukung pada Takut Pengiriman dan Hasil Kerja: A Single-Blind Acak Terkendali Percobaan

  • 1. Burn-care in Practice The necessity for hand therapy interventions for patients with partial thickness isolated hand/forearm burns: A randomized controlled pilot trial Bradley J. Schmitt a,⇑ , Kathy Stiller b , Kathryn E. Heath a , Tanja Klotz a , John E. Greenwood a a Adult Burns Service, Royal Adelaide Hospital, Australia b Central Adelaide Local Health Network, Australia a r t i c l e i n f o Article history: Received 30 April 2018 Received in revised form 10 September 2018 Accepted 10 September 2018 Available online 15 September 2018 Keywords: Burns Skin Artificial Physical therapy modalities Hand Injuries a b s t r a c t Objective: The recovery of patients with partial thickness isolated hand burns managed with an epider- mal skin substitute appears to be rapid and the necessity for routine hand therapy interventions in this setting is unknown. This study investigated the need for hand therapy for these patients. Methods: A randomized controlled trial was undertaken. The Treatment Group received routine hand therapy provided by a physiotherapist, including assessment, daily range of motion exercises, education and, if required, edema management and outpatient physiotherapy follow-up. Control Group participants received no hand therapy input. Outcomes included the Michigan Hand Questionnaire (baseline, 1, 2, 4 weeks and 3 months post-injury), finger total active motion, wrist range, grip strength (1, 2 and 4 weeks) and participant satisfaction (4 weeks). Results: Twenty-nine participants were recruited over a 2.3 year period. All outcomes significantly improved over time (p 0.008). No significant between-group differences were observed for any out- come except the pain subscale of the Michigan Hand Questionnaire. Participants with deeper burns had significantly poorer outcomes for some Michigan Hand Questionnaire data. Study limitations included a small sample size, heterogeneity and some loss to follow-up. Conclusions: While the provision of routine hand therapy interventions for patients with partial thickness isolated hand/forearm burns that were managed with an epidermal skin substitute did not appear to be of benefit, study limitations means these results cannot be extrapolated and reinforces the need for further research. Routine hand therapy input may be of benefit for those with deeper burns. Ó 2018 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). 1. Introduction Burn injuries result in only a small fraction (1%) of hospitaliza- tions but can have major consequences on those affected in terms of their quality of life and return to functional activities [1]. The hand is particularly susceptible to burn injury, occurring in up to 90 percent of those with major burn injuries and, despite involving only a relatively small area, hand burns can have a major impact on function, appearance and quality of life [2–4]. The management of hand burns varies according to the severity of the burn injury and may include conservative management (when presentation is delayed or the burns are very small in area) where natural recovery and spontaneous healing is allowed, the application of epidermal skin substitutes (e.g. BiobraneÒ , AWBATTM , SuprathelÒ ) if the burns are acute and superficial, through to excision and split skin grafting of deep burns. A prospective audit undertaken at our burns unit by Williams et al. [5], where the outcomes of 52 patients with isolated hand burns were reviewed, found that patients with superficial or partial thickness burns had rapid recovery in range, grip strength and hand function, with normal or near-normal values achieved within 2–4 weeks post-injury. In contrast, those patients with full thick- ness burns requiring split skin grafting demonstrated more marked initial deterioration, a slower rate of improvement, but eventually good recovery by 12 months. All patients included in this study received standard assessment and interventions by nursing and allied health staff which, from a hand therapy perspective, included early assessment, daily range of motion (ROM) exercises that were supervised/assisted by a physiotherapist, education and, as required, edema management, scar management and https://doi.org/10.1016/j.burnso.2018.09.001 2468-9122/Ó 2018 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). ⇑ Corresponding author at: 7G-170, Royal Adelaide Hospital, Port Road, Adelaide, South Australia 5000, Australia. E-mail address: Brad.Schmitt@sa.gov.au (B.J. Schmitt). Burns Open 2 (2018) 171–177 Contents lists available at ScienceDirect Burns Open journal homepage: www.burnsopen.com
  • 2. outpatient physiotherapy follow-up [5]. Whilst these hand therapy interventions appear extensive, our clinical experience, both dur- ing this study and since, is that the majority of patients with partial thickness burns that are able to be managed with an epidermal skin substitute require relatively few hand therapy interventions: after an initial assessment and provision of ROM exercises, most patients recover quickly and only require brief re-assessment thereafter. Given that the recovery of patients with superficial or partial thickness isolated hand burns, that were able to be managed con- servatively or with epidermal skin substitute application, was rapid and the amount of hand therapy required was low, it raises the question of whether any routine hand therapy interventions are required for these patients. In a healthcare setting where resources (e.g. time, staffing) are limited, the ability to focus hand therapy interventions on those patients who require them is essen- tial. Therefore, the aim of this study was to compare standard hand therapy interventions to no hand therapy interventions for patients with partial thickness isolated hand/forearm burns that were managed with application of an epidermal skin substitute. 2. Methods 2.1. Design A randomized controlled trial with intention-to-treat analysis, assessor blinding and concealed allocation was undertaken. The study was approved by the Royal Adelaide Hospital Research Ethics Committee and registered with the Australian New Zealand Clini- cal Trials Registry (ACTRN 12614000401651). 2.2. Setting and participants The study was undertaken at the Royal Adelaide Hospital, a 650-bed, tertiary-care, urban, public hospital in Australia from July 2014 until November 2016. The Royal Adelaide Hospital Adult Burns Service admits approximately 450 patients per year. Potential participants were adults (18 years) admitted to the Royal Adelaide Hospital Adult Burns Service for management of a partial thickness isolated unilateral hand/forearm burn that was managed with the application of an epidermal skin substitute. For the purposes of this study, an isolated hand/forearm burn was defined as a burn affecting the hand alone or the hand and extending into the distal third of the forearm. Exclusion criteria were: unwillingness to participate; inability to understand writ- ten/spoken English, other concomitant major injuries (e.g. major bony fracture) or a pre-existing condition (e.g. tetraplegia, paraple- gia) that could adversely affect outcomes, inability to return for follow-up appointments, or that the circumstances of the burn injury were considered so traumatic that a request to consider par- ticipating in the study was deemed inappropriate (e.g. self-inflicted burn injury or where another person had died). 2.3. Study protocol Patients were recruited by the principal investigator (BS) and after providing informed written consent were randomly allocated to a treatment or control group using randomly permuted blocks of four. The randomization schedule was generated by an indepen- dent statistician using the ralloc command in Stata version 13, with group allocation stored on a password-protected spreadsheet and revealed by an independent staff member not otherwise involved in the study. All participants received usual medical and nursing care as clin- ically indicated. In our burns unit, physiotherapists routinely pro- vide hand therapy interventions with occupational therapists providing scar management if required. All participants received the epidermal skin substitute (BiobraneÒ ) which was applied under general anesthetic within 48 h of burn injury and the affected area immobilized with a boxing glove dressing for 2– 3 days. Hospital discharge usually occurred between day 1–3 post-application of the skin substitute. Patients returned to out- patients for burn assessment and dressing changes by nursing staff twice a week until the skin substitute was removed, which was 2 weeks post-burn injury. This out-patient follow-up continued until the burn was healed and/or full hand function had been achieved, which usually ranged from 10 days to 4 weeks. Treatment Group participants received hand therapy interven- tions from a physiotherapist as per our usual clinical practice. This comprised: assessment, education, provision and supervision of exercises for the non-affected joints in the affected limb on the first day after application of the epidermal skin substitute; daily provi- sion, supervision and assistance during hospital admission of ROM exercises for the affected joints once cleared for movement by the burns surgeon (usually day 2 or 3 post-application [which may have occurred post-hospital discharge]); provision of a patient education pamphlet detailing these exercises; provision of an off- the-shelf compression glove or elasticated tubular bandage (i.e. TubigripÒ ) as required; assessment/interventions for follow-up out-patient physiotherapy as required. Control Group participants received no hand therapy assessment or interventions from a physiotherapist and did not receive the patient education pam- phlet. All participants received assessment/interventions for scar management (from an occupational therapist) if required (usually after 2 weeks). Any participant who failed to improve, primarily based but not restricted to a total Michigan Hand Questionnaire (MHQ) score 50 at 2 weeks, received hand therapy assessment and interven- tions as required, irrespective of their group allocation. Their data were included in analyses. This MHQ cut-off score was based on data reported by Williams et al. [5] where the mean (standard deviation [SD]) value for patients with partial thickness isolated hand burns and managed with an epidermal skin substitute was 70 (21) at 2 weeks and thus a score of 50 was approximately equal to the mean value minus one SD. Medical, nursing and occupational therapy staff were not informed of group allocation. 2.4. Outcomes The primary outcome was the MHQ which is a hand-specific instrument comprising 37 core questions measuring outcomes of patients with conditions or injuries (including burns) to the hand or wrist [6–9]. It has six scales (overall hand function, single- handed activities of daily living [ADL], work performance, pain, aesthetics, and patient satisfaction with hand function), with an optional extra scale evaluating the ability to undertake two- handed ADL. Each item has five possible responses (ranging, for example, from 1 = not at all difficult to 5 = very difficult), and the raw scores for each scale are converted to a score ranging from 0 to 100. For the pain scale, a higher score indicates greater pain, whereas for the other five scales higher scores indicate better hand performance. An overall score (0–100) can also be calculated. The MHQ is easy to administer, can be self-administered or adminis- tered by research personnel, takes approximately 15 min to com- plete and has been shown to be responsive to change with good psychometric properties, albeit in non-burn injured populations [5–7]. During the current study, the MHQ was completed by the participant. If a participant failed to attend an out-patient appoint- ment, the MHQ was emailed or posted for them to complete inde- pendently and return via email or in a reply-paid envelope. 172 B.J. Schmitt et al. / Burns Open 2 (2018) 171–177
  • 3. Active ROM of the hand was measured using a finger goniome- ter, with the patient simultaneously flexing all finger joints maxi- mally. The sum of flexion at all joints (metacarpophalangeal, proximal interphalangeal and distal interphalangeal joints) minus the sum of any extension deficit at these joints was added to give total active motion (TAM). This approach provides one functional composite ROM for each digit (not including the thumb). A mean TAM was then calculated for the affected hand [10,11]. TAM has been used extensively in studies evaluating outcomes after hand injuries, including burn injury, and is quick and easy to use [5,11–13]. Active wrist ROM (flexion and extension) was also mea- sured. All ROM measurements were performed using a goniometer in positions recommended by the American Society of Hand Ther- apists [14]. Grip strength was used as a global assessment of hand strength and measured using a calibrated Jamar dynamometer (JA Preston Corporation, Jackson, MI) on setting two to ensure maximal grip strength, as per the American Society of Hand Therapist guidelines [15]. Given the study sample (i.e. hand burns) and the acuity of the burn injury, we elected to record a single maximal attempt at grip strength [16] even though the validity of doing this has not been specifically evaluated in hand burns patients. Grip strength is quick and easy to perform, reliable when performed in a standardized fashion [17], reliable and valid in strength assessment for patients with minor burns [18] and has been previously used as an outcome measure for patients with burn injuries [5,10,19]. Based on the results of our previous research, MHQ, ROM and grip strength were recorded for all participants at weeks 1, 2 and 4 post-application of the skin substitute [5]. The MHQ was also measured for all participants at admission to hospital (with partic- ipants asked to respond as they were prior to their burn injury) and at 3 months post-burn injury. Other outcome data collected included the number and type of hand therapy interventions from a physiotherapist (Treatment Group), number of participants requiring occupational therapy intervention for scar management, and participants’ rating of their satisfaction with their allocated group intervention (rated at 4 weeks post-injury using a simple verbal analogue scale where 0 = not at all satisfied and 10 = completely satisfied). The therapist-rated outcomes (i.e. ROM, grip strength) were measured by a blinded assessor (KH, TK). A training session for assessors was held before commencement of data collection to ensure measurements were performed in a standardized manner. Participants were instructed not to discuss any aspect of the trial with the assessor to aid maintenance of blinding. Background data for each participant were collected from med- ical records and/or personal interview by one of the investigators. These data included gender, age, past medical history (focussing on conditions potentially impacting on hand function [e.g. alcohol/ drug use, chronic pain]), handedness, percentage of total body surface area (TBSA) burned, length of hospital stay and hospital complications. We also recorded whether the epidermal skin sub- stitute application was categorized at the time by the treating burns surgeon as being ‘trial of life’, meaning that the depth of the burn was deep partial thickness and thus on the borderline of being able to be managed with an epidermal skin substitute or necessitating split skin grafting. Time to epithelialization data were also retrieved from out-patient records. 2.5. Data analyses Demographic and clinical characteristics of participants were compared between groups using Chi Square tests and independent samples t tests for categorical and interval data respectively. Differences over time and between groups for outcome measures were analysed using repeated measures analysis of variance (RM ANOVA). Analyses were conducted on an intention-to-treat basis, using all available data from randomized participants. Analyses were performed using SPSS. P values 0.05 were consid- ered significant. 3. Results 3.1. Study participants A total of 52 patients were admitted to the Royal Adelaide Hospital Adult Burns Service for management of a partial thickness isolated unilateral hand/forearm burn that was managed with the application of an epidermal skin substitute and thus were screened for eligibility (Fig. 1). Of these, 29 (56%) met the inclusion criteria and were randomized. No participants were withdrawn from the study because of the need for skin grafting. The main reason for exclusion was an inability to return for follow-up due to residing in a rural area (Fig. 1). Baseline demographic and admission details were similar for the two groups (Table 1). 3.2. Compliance with trial Hand therapy interventions for the Treatment Group were pro- vided by a physiotherapist as scheduled on 100% of occasions. The mean (range) total number of physiotherapy visits for the Treat- ment Group was 4.1 (3–6), with 1.5 (1–2) and 2.7 (1–4) visits pro- vided as an in-patient and out-patient respectively. The mean (range) total physiotherapy time per Treatment Group participant was 116.0 (70–190) min, with 46.3 (20–80) and 69.7 (40–130) min provided as an in-patient and out-patient respectively. All 15 par- ticipants in the Treatment Group received assessment, education, exercises for the affected joints and non-affected ipsilateral joints. Of the 15 Treatment Group participants, 11 (73%) received an off-the-shelf compression glove and 3 (20%) were provided with TubigripÒ for edema control. No adverse effects resulting from these physiotherapy interventions were reported. For the 29 randomized participants, MHQ data were obtained at baseline, weeks 1, 2, 4 weeks and 3 months for 29 (100%), 29 (100%), 29 (100%), 23 (79%) and 16 (55%) participants respec- tively. Data for TAM, wrist range of motion and grip strength were obtained at weeks 1, 2 and 4 for 29 (100%), 28 (97%) and 19 (65%) participants respectively. Patient satisfaction data were obtained for 16 (55%) participants. The breakdown of these data by group allocation can be found in Table 2. The therapists who acted as independent assessors reported no episodes of unblinding. 3.3. Main results Outcome data are summarized in Table 2. There was an improvement in all outcomes over time, with this improvement significant for all outcomes. No significant group effect was seen for any outcome except MHQ pain. No group effect was seen for patient satisfaction measured at 4 weeks. In total, six participants (Treatment Group = 5, Control Group = 1) received occupational therapy intervention, in all cases for scar management (p = 0.082). In total, 5 (30%) Treatment Group participants and 3 (21%) Control Group participants (p = 0.474) had a MHQ total score 50 at 2 weeks and thus received hand therapy assessment and inter- ventions as required, irrespective of their group allocation. As the 5 Treatment Group participants with a low MHQ total score were already receiving hand therapy, this therapy continued essentially unchanged. The 3 Control Group participants with a low MHQ total score received, as a result of their low MHQ total score, a one-off hand therapy assessment/interventions at 2 weeks but B.J. Schmitt et al. / Burns Open 2 (2018) 171–177 173
  • 4. unfortunately all 3 failed to attend further appointments and were lost to follow-up at both 1 and 3 months. 3.4. Other influencing factors We reviewed our data for other clinical factors that may have affected outcomes (e.g. burn depth [trial of life], whether the burn injury involved the dominant or non-dominant side). As noted in Table 1, 4 (27%) and 2 (14%) participants in the Treatment and Control Groups respectively had deep partial thickness burns and thus received the epidermal skin substitute as a trial of life. We also compared time to epithelialization between those participants with deep partial thickness burns (i.e. trial of life; n = 6) to those with partial thickness burns (n = 23), finding a significantly longer time to healing for those with deeper burns (means [SDs] = 31.2 [8.8] and 16.2 [6.8] days respectively; p = 0.000), suggesting the categorization of burn depth at the time of the burn injury was accurate. RM ANOVA, using burn depth (trial of life) as a co-variant (in addition to group allocation), revealed that this had a signifi- cant effect on the following outcomes: MHQ total (p = 0.019), MHQ overall function (p = 0.030), MHQ ADLs single-handed (p = 0.000), MHQ patient satisfaction (p = 0.033) and MHQ ADLs two-handed (p = 0.006) and, in all instances was associated with poorer outcomes. No significant effect was seen for group alloca- tion whereas, with the exception of MHQ appearance, a significant effect was seen for time. Even for those outcomes where signifi- cance was not achieved, outcomes were poorer for those with deep partial thickness burns where the skin substitute was categorized as a trial of life compared to those who were not. Burn depth (i.e. trial of life) also seemed to influence the proportion of partic- ipants with a MHQ total score 50 at 2 weeks (3 of 8 participants [37.5%] with a low MHQ total score compared to 3 of 21 [14.3%] for those without a low MHQ total score). We also compared the hand therapy input by a physiotherapist for Treatment Group partici- pants according to burn depth (trial of life), finding that the mean (SD) total physiotherapy time was significantly greater for the Fig. 1. Design and flow of participants through the trial. 174 B.J. Schmitt et al. / Burns Open 2 (2018) 171–177
  • 5. 4 participants where epidermal skin substitute application was categorized as being trial of life compared to the 11 other partici- pants (155.0 [35.8] vs 101.8 [25.7] min respectively, p = 0.007). Four of the 6 participants (67%) who received the skin substitute application as a trial of life required scar management intervention from occupational therapists once healing had occurred, compared to 2 of 23 participants (9%) where it was not classified as a trial of life. Hand dominance did not have a significant effect on outcomes. In view of the significant influence that burn depth (trial of life) had on MHQ outcomes, we also analyzed our outcome data sepa- rating our sample according to depth of burn (i.e. partial thickness burns or deep partial thickness burns [where the skin substitute was categorized as a trial of life]) and then compared intervention groups (RM ANOVA) within each sub-group. In summary, for the partial thickness burns sub-group, no significant difference was seen between intervention groups for any outcome (p 0.106). Similarly, for the deep partial thickness burns sub-group, where the number of participants available for analyses was low, no significant difference was seen between intervention groups (p 0.094). 4. Discussion This randomized, controlled, single-blinded trial compared the effectiveness of standard hand therapy treatment to no hand ther- apy treatment for patients with partial thickness isolated hand/- forearm burns that were managed with an epidermal skin substitute. Significant improvements in all outcomes were seen over time, but no significant differences between groups were detected except for MHQ pain. Deep partial thickness burns, where the application of the skin substitute was classified as a trial of life, was associated with significantly poorer outcomes for some MHQ data. However, given the nature of our study, with a relatively small sample, some heterogeneity and loss to follow-up (especially after 4 weeks), these results cannot be extrapolated and further research is required. Our results were similar to those of Williams et al with respect to MHQ data, although grip strength in our study (means of 30 and 32 kg at 2 and 4 weeks) was lower than that reported by Wil- liams et al (medians of 41 and 46 kg at 2 and 4 weeks), most likely reflecting the greater proportion of males in their sample [5]. Also similar to Williams et al, we found that patients with deeper hand burn injuries (i.e. deep partial thickness) had slower recovery of hand function [5]. Other studies have also reported a slower recov- ery of hand function for deeper hand burn injuries [20–22]. Inter- estingly, length of hospital stay for patients reduced from a mean of 4 days in the study by Williams et al to 2 days in the current study, which most likely reflects recent clinical practice whereby earlier discharge is sought [5]. Our results for MHQ, which was the only outcome measure where we were able to obtain a quasi pre-injury measurement, showed a steady increase over time and return to near baseline values at 3 months for all MHQ scales except aesthetics. We believe these results reflect acceptable recovery. Our findings are important as this study is one of the first, if not the first, randomized controlled trial evaluating the effectiveness of hand therapy after burn injury. Other strengths of our study include the wide range of outcome measures used, covering both therapist-measured and patient-reported outcomes and including measures of function and satisfaction. The significant improve- ments seen over time using these outcome measures reflects their Table 1 Demographic and clinical characteristics of participants by treatment group. Treatment Group n = 15 Control Group n = 14 P values* Gender, n (%) Male 8 (53) 9 (64) 0.413 Female 7 (47) 5 (36) Age, years, mean (SD) 35.5 (17.4) 43.2 (12.4) 0.186 Past medical history, yes, n (%) Alcohol/drug 5 (33) 1 (7) 0.082 Smoker 3 (20) 3 (21) 0.924 Diabetes 1 (7) 0 (0) 0.326 Previous hand/wrist injury 0 (0) 2 (14) 0.129 Mechanism of burn injury, n (%) Scald 8 (53) 7 (50) 0.674 Flame 3 (20) 5 (36) Flash 1 (7) 1 (7) Contact 3 (20) 1 (7) TBSA, mean (SD) 1.5 (1.0) 1.6 (0.7) 0.768 Affected hand, n (%) Dominant 9 (60) 9 (64) 0.812 Non-dominant 6 (40) 5 (36) Area burnt, n (%) Fingers 9 (60) 13 (93) 0.039 Palmar hand 1 (7) 3 (21) 0.249 Dorsum hand 12 (80) 9 (64) 0.344 Forearm 9 (60) 9 (64) 0.812 Depth of burn, n (%) Superficial partial thickness/mid dermal 11 (73) 12 (86) 0.651 Deep partial thickness (trial of life) 4 (27) 2 (14) Hospital length of stay, days, mean (SD) 2.9 (1.4) 2.1 (0.6) 0.055 SD, standard deviation; TBSA, total body surface area. * Categorical data were compared using Chi Square analyses: for those data where only one response was possible one Chi Square result has been provided, whereas for those data where multiple responses were possible Chi Square analyses were done for each response (i.e. comparing the number of yes/no responses). Interval data were compared using Independent Samples t tests. B.J. Schmitt et al. / Burns Open 2 (2018) 171–177 175
  • 6. Table 2 Outcome data of participants by treatment group. Treatment Group n = 15 Mean (SD) [n] Control Group n = 14 Mean (SD) [n] P values* MHQ total (0–100) Admission (baseline) 99.0 (2.5) [15] 96.4 (6.1) [14] 0.000 time 1 week 38.8 (18.4) [15] 46.4 (19.5) [14] 0.131 group 2 weeks 62.8 (20.7) [15] 67.8 (22.8) [14] 4 weeks 76.5 (15.1) [13] 89.6 (11.5) [10] 3 months 95.1 (3.0) [9] 95.1 (3.2) [7] MHQ overall hand function Admission (baseline) 99.0 (2.1) [15] 93.8 (9.2) [14] 0.000 time 1 week 42.3 (19.4) [15] 53.9 (19.8) [14] 0.402 group 2 weeks 70.3 (22.9) [15] 70.4 (20.0) [14] 4 weeks 85.0 (14.7) [13] 88.0 (14.0) [10] 3 months 94.4 (9.2) [9] 95.7 (7.3) [7] MHQ ADLs (single-handed) Admission (baseline) 99.3 (1.8) [15] 95.0 (9.8) [14] 0.000 time 1 week 33.0 (30.3) [15] 35.4 (25.9) [14] 0.621 group 2 weeks 67.7 (32.9) [15] 74.3 (20.7) [14] 4 weeks 88.5 (12.8) [13] 93.5 (7.8) [10] 3 months 99.4 (1.7) [9] 96.1 (6.1) [7] MHQ work performance Admission (baseline) 99.0 (2.8) [15] 94.6 (11.7) [14] 0.000 time 1 week 35.7 (38.8) [15] 30.4 (29.4) [14] 0.190 group 2 weeks 43.3 (36.9) [15] 56.8 (35.6) [14] 4 weeks 59.2 (31.7) [13] 88.0 (27.9) [10] 3 months 96.7 (7.1) [9] 98.6 (3.8) [7] MHQ pain Admission (baseline) 0.7 (2.6) [15] 3.2 (8.2) [14] 0.000 time 1 week 61.3 (20.1) [15] 48.9 (25.4) [14] 0.038 group 2 weeks 31.7 (23.8) [15] 26.1 (25.3) [14] 4 weeks 17.7 (15.8) [13] 8.5 (14.5) [10] 3 months 0.0 (0.0) [9] 0.0 (0.0) [7] MHQ aesthetics Admission (baseline) 97.5 (9.7) [15] 98.2 (4.5) [14] 0.000 time 1 week 43.3 (28.5) [15] 56.8 (23.2) [14] 0.070 group 2 weeks 49.2 (27.5) [15] 63.4 (26.3) [14] 4 weeks 56.7 (28.7) [13] 83.1 (17.9) [10] 3 months 77.8 (21.7) [9] 80.4 (22.9) [7] MHQ patient satisfaction Admission (baseline) 99.4 (1.5) [15] 98.2 (4.6) [14] 0.000 time 1 week 38.1 (30.3) [15] 47.0 (24.6) [14] 0.646 group 2 weeks 72.5 (25.1) [15] 67.6 (30.8) [14] 4 weeks 86.5 (14.6) [13] 92.9 (9.6) [10] 3 months 99.5 (1.4) [9] 98.2 (3.3) [7] MHQ ADLs (two-handed) Admission (baseline) 99.7 (1.0) [15] 98.0 (5.0) [14] 0.000 time 1 week 36.9 (29.0) [15] 43.4 (27.7) [14] 0.710 group 2 weeks 68.8 (29.6) [15] 75.5 (23.9) [14] 4 weeks 85.2 (18.0) [13] 94.3 (10.9) [10] 3 months 99.6 (1.2) [9] 99.0 (1.8) [7] Total active motion (degrees) 1 week 226.5 (77.9) [15] 213.2 (31.9) [14] 0.008 time 2 weeks 265.4 (34.6) [15] 250.1 (29.1) [13] 0.772 group 1 month 285.9 (25.4) [12] 257.7 (30.3) [7] Wrist extension 1 week 57.7 (13.9) [15] 51.1 (24.9) [14] 0.005 time 2 weeks 65.5 (9.2) [15] 60.9 (17.2) [13] 0.731 group 1 month 69.8 (10.2) [12] 61.6 (13.3) [7] Wrist flexion 1 week 66.3 (9.8) [15] 53.6 (17.0) [14] 0.001 time 2 weeks 78.2 (8.9) [15] 66.1 (15.5) [13] 0.786 group 1 month 80.6 (8.8) [12] 65.3 (13.4) [7] Grip strength (kg) 1 week 20.8 (13.8) [15] 23.5 (13.0) [14] 0.000 time 2 weeks 28.9 (10.2) [15] 31.3 (11.4) [13] 0.712 group 1 month 32.3 (10.2) [12] 33.0 (11.6) [7] Patient satisfaction (VAS) 9.6 (0.5) [10] 7.5 (3.3) [6] 0.167 ADLs, activities of daily living; MHQ, Michigan Hand Questionnaire; VAS, verbal analogue scale. * P values are shown for the effect of time and group allocation. 176 B.J. Schmitt et al. / Burns Open 2 (2018) 171–177
  • 7. sensitivity for this cohort. One of the main limitations of our study was the relatively small sample size despite recruitment lasting 2 years due to our tight inclusion criteria. Another main limitation was that despite our best attempts to recruit a homogenous sam- ple (by limiting recruitment to patients admitted with partial thickness isolated hand burns that were managed with an epider- mal skin substitute), our sample still exhibited some heterogeneity (e.g. burn depth), which in turn impacted on outcomes. These lim- itations highlight the difficulty of conducting research in a burns population. Our study was single-site only and, because of the need to return for follow-up, most patients recruited to the study resided in a metropolitan area, which could potentially have influ- enced our results. Our choice of using the MHQ as our main out- come measure could be questioned, however we chose it given our previous positive experience of using it with a similar patient population [5], even though its psychometric properties have not been formally measured in this setting. Our decision to record a single maximal attempt at grip strength could also be questioned and means we were unable to quantify any learned effect for this outcome. There was some loss to follow-up over time, particularly the 3 month MHQ data and the therapist-rated outcomes, however retention up to 4 weeks was reasonably good. It is also acknowl- edged that whilst therapist-rated outcomes were measured by blinded assessors, nursing and medical staff may have become aware of participants’ group allocation. Nursing staff may also have encouraged hand movement and function as part of their routine clinical practice. Further research is required to confirm and extend the results of this study. In particular, randomized, controlled trials with larger sample sizes would be beneficial and multi-centred trials would allow the results to be more generalizable. Similar randomized controlled trials could be undertaken with other smaller TBSA burns and with different management protocols. In conclusion, this randomized, controlled, single-blinded trial involving patients with isolated hand/forearm burns that were managed with the application of an epidermal skin substitute, found no significant difference between those who did or did not receive routine hand therapy, whereas routine hand therapy may be of benefit for those with deep partial thickness burns. However, the limitations of our study means these results cannot be extrap- olated and further research with larger samples is required to con- firm and extend our findings. Conflicts of interest and source of funding None declared. References [1] AIHW: Pointer S, Tovell A. 2016. Hospitalised burn injuries, Australia, 2013-14. 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