This document proposes revisions to the original SACS Classification for Peristomal Skin Disorders. The authors conducted a multi-center study observing lesions that could not be classified by the original SACS method. They defined a new L5 lesion involving loss of substance beyond the fascial plane. The study aimed to include this new lesion in the classification and classify all lesions present rather than just the most serious lesion. Based on the study findings, the authors propose a revised classification called SACS 2.0 that retains the original classification's objectivity while integrating the new L5 lesion and allowing for classification of multiple concurrent lesions.

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ABSTRACT
About eight years have passed since the publication of the SACS
Classification, the use of which has proved to be essential in
Italy, not only on account of the particular characteristics of this
instrument but also and above all as it is a point of reference for
debate and discussion and aims to facilitate an objective awareness
of peristomal skin lesions.
Many outpatient clinics have adopted it as an indispensable
instrument for communication both in Europe and in the rest of
the world and the SACS Classification has now become a part of
consolidated everyday clinical practice.
In light of the experience that has been acquired a review of the
instrument is proposed, which will also be able to take into account
and classify lesions, albeit rare, which until now could not fall
under the same classification.
We have thus focused on the study and observation of lesions
that are unclassifiable or which may be classified in a manner
that cannot be reproduced with the SACS method, enrolling a
significant number of patients with a view to proposing a new
system that will integrate the newly-defined lesion (L5). As a
tribute to the original name the new instrument has been called
SACS 2.0.
A systematic review of the international literature was carried
out in order to identify articles illustrating work aimed at
improving the SACS Classification. Our search highlighted a
total lack of studies regarding this subject and so, a few years
after the publication of our study, we were convinced of the need
to propose a new classification which would be an improvement
with respect to the previous version. The inclusion of an additional
descriptive clinical picture of a lesion such as L5 and the possibility
to classify any lesion present in the peristomal quadrant makes the
classification more precise for the health professional.
The purpose of this study was the review of the original SACS Scale
for Peristomal Skin Disorders Classification aimed at achieving two
main objectives:
A revised version of the original SACS Scale for
Peristomal Skin Disorders Classification
* Corresponding author
Antonini M*
RN ET
USL 11 Ospedale San Giuseppe
Empoli, Italy
Militello G
RN, ET
USL 4 Ospedale Santo Stefano
Prato, Italy
Manfredda S
RN, ET
ASL della Romagna Ospedale Ceccarini,
Riccione, Italy
Arena R
RN, ET
AO ARNAS Garibaldi, Catania, Italy
Veraldi S
MD, PhD
Department of Pathophysiology and
Transplantation, Università degli Studi di
Milano, I.R.C.C.S. Foundation
Cà Granda Ospedale Maggiore
Policlinico, Milan, Italy
Gasperini S
MD
Medical Advisor

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1. Completion of the Classification to include an additional level
of severity (L5).
2. Classification of all types of peristomal skin changes present,
eliminating the notion of “most serious lesion”.
Keywords: SACS Classification, abdominal stomas, peristomal
skin lesions, SACS 2.0, ostomy complication, objective assessment.
INTRODUCTION
During their life, many people who undergo surgical
procedures resulting in the creation of an ostomy have at
least one experience involving peristomal skin complications.
Irritant contact dermatitis is the most common peristomal
skin complication1,2
. In the literature we note an incidence
varying from 18% to 55%3
depending on the difference in the
parameters assessed in the various studies. Inconsistencies
in definition and measurement of complications have been
identified as limitations of prior research in ostomy care4,5
.
Differences in study methodology and samples, plus the lack
of precise measurement of complications, have all contributed
to wide variability in reported prevalence and incidence
rates6
. We trust this difference will be reduced following
publication of the SACS Classification7
. This classification
could be a standardised and objective tool useful for a proper
monitoring and follow-up of complications5
.
Peristomal skin alterations represent a significant problem
both for health care providers, in terms of their professional
duties and required procedures, and for stoma patients
themselves in terms of the quality of life following surgery.
An international study indicates significant facts concerning
the impact of peristomal skin alterations on the quality of life
in ostomates8,9
and peristomal skin alterations are the main
reason for which stoma patients visit outpatient clinics10
with
a considerable increase in both direct and indirect costs. Due
to methodological problems of peristomal skin disorders
(PSD) assessment, the associated health-economic burden
of medium- to long-term complications has been poorly
described. The estimated total average cost for a seven-week
treatment period was €263 for those with PSD compared to
€215 for those without PSD11
. The international literature
moreover refers to an incidence of 63% in relation to such
alterations8
. This appeared to be a rather alarming situation
requiring further investigation, and for this very reason some
years ago a group of Italian physicians and enterostomal
therapy nurses felt the need to classify peristomal skin
changes in order to establish uniformity in the language
adopted by health care workers. The result of this study is
better known as the SACS Classification7
, in which peristomal
skin changes were defined according to their severity. The
SACS study led to the definition of a simple, reproducible
and objective classification. The lesion is subdivided into
five clinical aspects and defined with the letter L, while the
letter T identifies the location of the lesion around the stoma.
This allows the enterostomal therapist to perform a correct
assessment of the lesion and introduce a degree of uniformity
in terminology and language adopted to describe peristomal
cutaneous alterations. This classification was first validated at
the national level and, subsequently, internationally7,12,17
.
Thanks to experience gained in this field, the authors of
the SACS Classification decided that a review of the SACS
instrument should be conducted in order to classify those
lesions, which, although rare, have not yet been identified
by the instrument. In this way the method is integrated and
enhanced with a new possibility to classify lesions which
had hitherto been impossible to categorise. (Figures 1 and
2: examples of lesions not considered in the original SACS
Classification and included in the SACS 2.0 Classification.
These lesions have been defined as L5: Ulcerative involving
planes beyond the fascia.)
A proper description and documentation of peristomal skin
changes and, in particular, the level of involvement of the
skin and underlying tissues is essential for a more precise
and correct form of communication between healthcare
providers13
. In particular, reference is made to that type of
lesion where the loss of substance is massive, where there is
the involvement of structures even below the fascial plane of
the abdominal wall and which, on account of their extension,
have a high production of exudate which is difficult to
manage in an ostomy patient14
(Figures 1 and 2).
MATERIALS AND METHODS
A multi-centre observational study was conducted in Italy
at four rehabilitation centres for ostomates (Empoli, Prato,
Rimini and Catania) involving the observation and recording
of peristomal skin changes and, in particular, those which,
on account of their characteristics, could not be properly
categorised according to the SACS Classification. The study
had an overall duration of two years, from 1 January 2013
to 31 December 2014. The centres involved in the study are
located in the central/southern regions of Italy, while the
study group was composed of four enterostomal therapy
nurses and two physicians. Three members of this group
were also the authors of the original SACS Classification.
To carry out the study, the coordinating centre submitted
an application and received the relevant authorisation from
the Ethics Committee. The other centres were included in
compliance with the corresponding regulations in force.
During the course of the two-year study, all patients
presenting peristomal skin changes and those with
ileostomies, colostomies and urostomies were enrolled.
The patients were asked to authorise their participation
in the study by reading and signing forms relating to the
privacy norms and giving their informed consent. All patients
enrolled in the study read and signed a written informed
consent for the acquisition and utilisation of digital images.
This procedure is a part of this study, but in some clinics,
such as San Giuseppe Hospital in Empoli and Santo Stefano

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Hospital in Prato, is a standard practice and part of a clinical
documentation.
The review of the original SACS study aimed at achieving
two main objectives:
- Completion of the classification to include an additional
level of severity (L5);
- Classification of all types of peristomal skin changes
present, eliminating the notion of “most serious lesion”.
(Figure 3).
The inclusion criteria provided that all patients with
peristomal skin disorders with ileostomies, colostomies and
urostomies would be enlisted in the study. The criteria for
exclusion included patients of minor age.
The peristomal skin disorders were categorised and
photographed according to the criteria of the SACS
Classification with the addition of the new L5 alteration,
at time 0 (T0) and subsequently checks were provided for
according to the following schedule: T1 (1 week); T2 (2
weeks); T3 (one month); T4 (2 months) T5 (3 months) and
T6 (6 months). The collection of data was carried out using
a specific form, in which the following parameters were
recorded at the established periods: body weight, bleeding,
itching, burning sensation, pain according to the VAS Scale15
and the outcome of biopsies. The procedure comprised an
accompanying SACS Classifications table (Figures 4 and 5).
At the end of the two-year study and once the required
sample had been obtained, the new classification was
validated (n = 426). This occurred first of all through three
consensus meetings. During these conferences the expert
panel, composed of 15 health professionals including
enterostomal therapist nurses, wound care nurses,
dermatologists, surgeons and phlebologists, has developed
and unanimously accepted the new SACS Classification
based on clinical observation and knowledge of the
mechanisms of peristomal skin injury. Subsequently, in order
to further improve the reproducibility and objectivity of the
classification, electronic transmission of the digital images
and classification on the part of the study group were added
to the process. This was later followed by blind validation
performed by an external validation team, using basically the
same method that led to the definition of the SACS scale.
RESULTS
Four hundred and twenty-six patients were recruited,
including 220 males and 206 females, presenting an average
age of 63.5 years and standard deviation (SD) of 37.47 (range
37 to 90 years). Forty-five per cent of patients enrolled in
the study had a colostomy, while 65% had an ileostomy.
Depending on initial pathology, 45% of patients were
following a chemotherapy protocol (Table 3).
L4 represents the condition of alteration most frequently
identified during our observation (66%). In our opinion,
this is caused by a series of factors which form part of the
Figures 1 and 2: Examples of lesions not considered in the original SACS categories and included in the SACS 2.0 classification (L5)
Figure 3: SACS Classification: an example in which classification is difficult
on account of the many different types of lesions occurring around the
ostomy: L2 T5 — erosive lesion with a loss of superficial substance (lesions
1, 2 and 3); L4, TII-III-IV — ulcerative fibrinous/necrotic lesion (lesions 5
and 6); LX, TIII-IV — proliferative lesion (lesion 4)

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Figure 4
Figure 5

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WCET Journal Volume 36 Number 3 – July/September 2016
Table 1
Primary stomal pathology Secondary stomal pathology Special pathology
Malposition Portal hypertension Psychic disorders
Oedema Neoplastic replication Metabolic alterations
Retraction Inflammatory colopathy Urogenital dysfunction
Peristomal suppuration Infective and parasitic diseases
Fistula Pharmaceutically-caused lesions
Stenosis
Prolapse
Peristomal hernia
Granulomas
Trauma
Cutaneous lesions
Table 2
TIME Ostomy complications Peristomal complications Cutaneous signs
Immediate post-operative
complications
(0–72 hours)
Oedema Peristomal skin disorders
(PSD)
Cutaneous alterations
Ischaemia and necrosis Candidiasis
Infection
Intra- and peristomal
haemorrhage
Folliculitis or other bacteria
Malpositioning Pseudo-verrucous lesions
Proliferation
Poor creation of the
colostomy
Oxalates deposit
Late post-operative
complications
Retraction Neoplasia
Prolapse Mucocutaneous
detachment
Ulcer
Fistula Pressure ulcers
Stenosis CID
Hernia Pyoderma gangrenosum
Trauma Trauma
Pseudo-inflammatory
polyps
Dermatitis artefacta
Psoriasis
Dermatological disease
at a different anatomical
location
Eczema
Seborrheic dermatitis

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general picture of complications. The creation of an ostomy,
often performed as an urgent intervention, or the length of
the loop to be externalised, the diameter of the orifice and
the extroversion of the opening from the surface of the skin
may in fact later determine problems in the management
of the ostomy with the appearance of severe lesions which
may have a serious effect on the quality of life of the
patient. These complications may be categorised as primary,
secondary or special (Table 1) or, as we prefer to identify
them, as complications that are peristomal or relating to the
ostomy. A record is made identifying whether they occur as
an immediate or delayed complication, together with the
cutaneous sign (Table 2).
The objective of the study group was mainly to ensure that
the fundamental characteristics of the SACS Classification
would remain intact: objectivity, reproducibility and ease of
use. We therefore proposed the sole inclusion of the condition
relating to the detection of a new non-classifiable lesion (L5)
— even though it has a low presence in our study (5%) —
while maintaining the other clinical pictures unaltered and
preserving the topography (T), simultaneously identifying
its location within a diameter of 15 cm (Table 4) and the
classification of numerous lesions. The sole classification
of the prevailing sign (most serious lesion) is reductive in
most cases and not explanatory for the health professional.
For example, ‘redness’ may exist as a single lesion (simple
redness — L1) or co-exist together with an ulcerative
fibrinous/necrotic lesion (L4) as a sign of inflammation/
infection, but may also not be present in an ulcerative lesion
(L3) as it is in the healing phase. In literature such situations
may be referred to as primary skin lesions present at the
onset of the disorder or as secondary skin lesions as a result
of modifications over time caused by the progression of
the disorder, manipulation, medications or the healing
process16
. During the course of the development of consensus
it was thus decided that each lesion present in the peristomal
quadrant should be classified (Figure 3: This is an example
of multiple Peristomal Skin Disorders classified with a new
SACS tool).
TOPOGRAPHY (T)
Legend: TI; TII; TIII; TIV; TV
I = upper right
II = upper left
III = lower left
IV = lower right
V = total
DISCUSSION
A systematic review of the international literature was carried
out in order to identify articles illustrating work aimed at
improving the SACS Classification. Our search highlighted
a total lack of studies regarding this subject and so, a few
years after the publication of our study, we were convinced
of the need to propose a new classification which would be
an improvement with respect to the previous version. The
Table 3
Population (patients enrolled) 426
Population (patients with lesion) 255 60%
Males 120 47%
Females 135 53%
Age range 37–90 years
DS (standard deviation) 37.47
Average 63.5
Colostomy 110 43%
Ileostomy 102 40%
Urostomy 43 17%
L1: Erythematous lesion 61 24%
L2: Erosive lesion 74 29%
L3: Ulcerative lesion 23 9%
L4: Ulcerative with fibrin/necrotic lesion 66 66%
L5: Ulcerative involving planes beyond the fascia 13 5%
LX: Proliferative lesion 18 7%

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Table 4
Lesion (L) Definition
L1 Erythematous lesion (peristomal erythema without loss of substance)
L2 Erosive lesion with loss of substance as far as and not beyond the basal membrane
L3 Ulcerative lesion beyond the basal membrane
L4 Ulcerative fibrinous/necrotic lesion
L5 Ulcerative lesion involving planes beyond the muscular fascia (with or without fibrin, necrosis,
pus or fistula)
LX Proliferative lesion (neoplasia, granulomas, oxalate deposit)
L1: Erythematous
lesion (peristomal
erythema without
loss of substance)
L2: Erosive
lesion with loss
of substance as
far as and not
beyond the basal
membrane
L3 Ulcerative
lesion beyond the
basal membrane
L4 Ulcerative
fibrinous/
necrotic lesion
L5: Ulcerative
lesion involving
planes beyond the
muscular fascia
(with or without
fibrin, necrosis,
pus or fistula)
LX:
Proliferative
lesion
(neoplasia,
granulomas,
oxalate deposit)
inclusion of an additional descriptive clinical picture of a
lesion such as L5 and the possibility to classify any lesion
present in the peristomal quadrant makes the classification
more precise for the health professional.
We have maintained the basic characteristics of the original
SACS Study, on the basis of which it is objective, reproducible
and easy to use. We have also kept the L and T parameters
as essential cornerstones of the classification. This upgrade
tool offers, for all clinicians, a complete guideline for a correct
interpretation and diagnosis of skin disorders, characteristics
not present in other types of classification.
The use of the SACS instrument is important in terms of
determining and documenting skin lesions, in that it would
contribute to the exact measurement of the prevalence and
incidence of skin lesions, and that it would provide assistance
in clinical decision making17
.
In addition to the necessary modifications to the original
classification it should be noted that the study group is
currently working on a new diagnostic proposal for each ‘L’
condition, which, in all likelihood, we will refer to as ‘Ld’
(lesion diagnosis) and to which will necessarily correspond
to a topical or systemic therapeutic proposal referred to as
‘R’ (resolution). This additional contribution will probably be
presented during 2016.
LIMITATIONS
The low rate of lesion L5 is a limitation of this study, but only
for the numerosity of the sample. However, the numerosity
of this type of lesion is strongly influenced by risk factors
such as: abdominal operative procedure, operative time,
emergency procedure and clean wound classification18
.
Dehiscence of peristomal suture means the breaking down,
or splitting open, of all or part of a wound healing by first
intention19
. Consequently the need to implement the existing
classification with a type of clinical picture that interested the
abdominal structures beyond the dermis.
However, we need to replicate data collection at
the international level in order to have a more accurate
clinical description of the prevalence and incidence of this
complication.
CONCLUSIONS
The SACS Classification has unquestionably achieved its
goal by placing at the disposal of professionals who
follow ostomy patients a useful tool in everyday clinical
practice, and guiding them towards a holistic approach
with respect to peristomal lesions, providing the attention
they deserve and defining their main characteristics. We
support and wholeheartedly advocate such an objective and
have thus proposed an amendment to the Classification,
adding a lesion that was missing and suggesting a multilevel

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Roll of Honour Industry 2016
Norma N Gill Foundation
The following companies have generously given donations
towards the NNGF scholarships
reading whenever necessary. We believe that this may
render more practical, reproducible and objective the work
of enterostomal therapists, and will in any case result in
enhanced treatment procedures for patients.
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