22

WCET Journal Volume 36 Number 3 – July/September 2016

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 GRN, ET USL 4 Ospedale Santo Stefano Prato, Italy

Manfredda SRN, ET ASL della Romagna Ospedale Ceccarini, Riccione, Italy

Arena RRN, ET AO ARNAS Garibaldi, Catania, Italy

Veraldi SMD, 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 SMD Medical Advisor

23

www.wcetn.org

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

24

WCET Journal Volume 36 Number 3 – July/September 2016

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)

25

www.wcetn.org

Figure 4

Figure 5

26

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

InfectionIntra- and peristomal haemorrhage

Folliculitis or other bacteria

Malpositioning Pseudo-verrucous lesions

ProliferationPoor 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

27

www.wcetn.org

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%

28

WCET Journal Volume 36 Number 3 – July/September 2016

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

29

www.wcetn.org

Roll of Honour Industry 2016

Norma N Gill Foundation

The following companies have generously given donationstowards 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.

REFERENCES1. Ostomy Guidelines Task Force, Goldberg M, Aukett LK et al.

Management of the patient with a fecal ostomy: best practice guideline for clinicians. J Wound Ostomy Continence Nurs 2010; 37: 596–8.

2. Cola B, Farella S, Bacalini GC, Palmerio B & Patrone P. Peristomal dermatitis. Etiopathogenetic, clinical and therapeutic considerations apropos of 102 cases. Minerva Chir 1984; 39:1565–70.

3. Turnbull G. Stomal complications: at what price? Ostomy Wound Manage 2003; 49(4):17–18.

4. Colwell JC & Beitz J. Survey of wound, ostomy and continence (WOC) nurse clinicians on stomal and peristomal complications: a content validation study. J Wound Ostomy Continence Nurs 2007; 34(1):57–69.

5. Szysmanski KM, St-Cyr D, Alam T & Kassouf W. External stoma and peristomal complications following radical cystectomy and ileal conduit diversión: a systematic review. Ostomy Wound Manage 2010; 56(1):28–35.

6. Salvadalena GD. The incidence of stoma and peristomal complications during the first 3 months after ostomy creation. J Wound Ostomy Continence Nurs 2013; 40(4):400–406.

7. Bosio G, Pisani F, Lucibello L et al. A proposal for classifying peristomal skin disorders: results of a multicenter observational study. Ostomy Wound Manage 2007; 53(9):38–43.

8. Nybaek H, Knudsen DB, Laursen TN, Karlsmark T & Jemec GB. Quality of life assessment among patients with peristomal skin disease. Eur J Gastroenterol Hepatol 2010 Feb; 22(2):139–43.

9. Marquis P, Marrell A & Jambon B. Quality of life in patients with stomas: The Montreux Study. Ostomy Wound Manage 2003; 49(2):48–55.

10. Rolstad BS & Erwin-Toth PL. Peristomal skin complications: prevention and management. Ostomy Wound Manage 2004; 50(9):68–77.

11. Meisner S, Lehur P-A, Moran B, Martins L & Jemec GBE. Peristomal skin complications are common, expensive and difficult to manage: a population-based cost modeling study. PLoS ONE 2012; 7(5): e37813. doi: 10.1371/journal.pone.0037813.

12. Beitz J, Gerlach M, Ginsburg P et al. Content validation of a standardized algorithm for ostomy care. Ostomy Wound Manage 2010; 56(10):22–38.

13. Korzendorfer H, Scarborough P & Hettrick H. Tissue destruction classification systems. Adv skin wound care 2013; 26(11):499–503.

14. Lampe KE. The general evaluation. In McCulloch JM, Kloth LC, eds. Wound Healing: evidence-based management. 4th ed. Philadelphia, PA: FA Davis Company, 2010: 65–93.

15. Wewers ME & Lowe NK. A critical review of Visual Analogue Scales in the measurement of clinical phenomena. Res Nurs Health 1990; 13(4):227–36.

16. Hess CT. Clinical Guide: Wound Care. 5th ed. Philadelphia, PA: Lippincott Williams & Wilkins, 2005.

17. Ay A & Bukut H. Assessing the validity and reliability of the Peristomal Skin Lesion Assessment Instrument adapted for use in Turkey. Ostomy Wound Manage 2015; 61(8):26–34.

18. Hodgetts KS, Carville K & Leslie GD. Determining risk factors for surgical wound dehiscence: a literature review. Int Wound J 2013. John Wiley & Sons Ltd and Medicalhelplines.com Inc doi: 10.1111/iwj.12088.

19. C. Dealey. The management of patients with acute wounds. In Dealey C. The Care of Wounds: A Guide for Nurses, 4th edn. John Wiley & Sons Ltd, 2012.