38 OstomyWound Management

FEATURE

How well ostomy patients adapt to their new

life depends, to a great extent, on the preser-

vation of peristomal skin integrity. The inci-

dence of peristomal complications that can compro-

mise that integrity cannot be easily determined; a

review of literature indicates a complication incidence

ranging from 18% to 55%.1 This extreme variability is

related to significant differences in study populations

and parameters assessed — eg, ostomy characteristics,

time of lesion onset post surgery (early, 1 to 15 days,

versus late, >15 days), types of complications, and

types of diversions (eg, intestinal versus urinary). It

appears evident that many patients undergoing uri-

nary or intestinal diversions experience at least one

type of complication after surgery. In the authors’

experience caring for nearly 700 patients per year over

A Proposal for Classifying PeristomalSkin Disorders: Results of a MulticenterObservational Study Giovanna Bosio, RN, ET; Francesco Pisani, MD; Luigi Lucibello, MD; Antonio Fonti, RN, ET; Assunta Scrocca,RN, ET; Christa Morandell, RN, ET; Laura Anselmi, RN, ET; Mario Antonini, RN, ET; Gaetano Militello, RN, ET;Diego Mastronicola, MD; and Stefano Gasperini, MD

The challenges of caring for abdominal ostomy disorders have grown over the years. Because the literature shows no evidence of atool to classify peristomal skin disorders, a study group comprised of seven enterostomal therapy nurses and four surgeons soughtto provide an objective, reproducible, standardized classification instrument. A prospective, observational study was conductedamong eight ostomy centers across Italy. The 339 patient participants (272 men, 67 women, average age 63 [25 to 85] years) weredivided into two groups according to onset of complications (less than or greater than 1 year); 800 digital photographs were takento enhance observation and blood samples were drawn for additional data. From the data obtained, a classification scheme was cre-ated and subsequently tested using four non-study group experts. The resulting instrument facilitated lesion interpretation and detec-tion, including topography. Thus far, this is the first validated classification attempt not based on assessments of lesions attributableto entirely different etiopathogenetic factors. Further research to refine the tool and to correlate the additional data obtained fromblood samples with the classification system is underway.

KEYWORDS: abdominal stomas, peristomal skin disorders, classification, ostomy complication, objective assessment

Ostomy Wound Management 2007;53(9):38–43

Ms. Bosio is an ET nurse, San Giovanni Battista Hospital, Le Molinette, Turin, Italy. Dr. Pisani is a surgeon, San Luigi-Currò HospitalCentre, Catania, Italy. Dr. Lucibello is a surgeon, Piemonte Hospital, Messina, Italy. Mr. Fonti is an ET nurse,Advanced SpecializationHospital, Garibaldi, Catania, Italy. Ms. Scrocca is an ET nurse, Campus Biomedico University Policlinic, Rome, Italy. Ms. Morandelland Ms. Anselmi are ET nurses, Regional Hospital, Bolzano, Italy. Mr. Antonini is an ET nurse, U.S.L. 11 Local Health Agency, SanGiuseppe Hospital, Empoli, Italy. Mr. Militello is an ET nurse, U.S.L. 4 Local Health Agency, Misericordia e Dolce Hospital, Prato,Italy. Dr. Mastronicola and Dr. Gasperini are Scientific Advisor and National Scientific Advisor, respectively, Bristol-Myers SquibbConvaTec Medical Department, Rome Italy. Please address correspondence to: Stefano Gasperini, MD, National Scientific Advisor,ConvaTec Division, Bristol-Myers Squibb, Via V. Maroso, 50-00142, Rome, Italy; email: stefano.gasperini@bms.com.Dr. Diego Mastronicola and Dr. Stefano Gasperini disclose they are employees of ConvaTec, a Bristol-Myers Squibb Company, Rome, Italy.

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a mean period of 10 years, it is estimated that at least

one third of colostomy patients and up to two thirds

of urostomy and ileostomy patients are affected by at

least one peristomal lesion. A published prospective

audit of numerous stomas to assess risk factors associ-

ated with peristomal skin complications demonstrat-

ed the close correlation between retractions and obe-

sity (P = 0.036), late skin excoriation and diabetes (P

= 0.02), stoma in crease, and ostomies performed as

emergency procedures (P = 0.022).2

After consulting national and international pro-

fessionals and conducting a careful

review of the literature, it became clear

that peristomal skin complications are

one of the least studied postoperative

complications. Skin disorders are gener-

ally recognized dermatologically and

classified as “simple” inflammatory skin

disorders related to mechanical, chemi-

cal, infectious, or allergic factors.3 In

recent years, management/classification

based on the stages of skin lesions bor-

rowed from other fields was attempt-

ed.4,5 Currently, a classification system is

used where complications are subdivid-

ed in terms of the timing of their occur-

rence. Early complications (occurring

within 1 to 15 days after surgery)

include edema, intra- and peristomal bleeding,

ischemia or necrosis, retraction, detachment of

mucocutaneous junction, suppuration and peris-

tomal abscess, complications due to malposition,

acute dermatitis, and skin lesions. Late complications

(occurring more than 15 days after surgery) include

hernia, prolapse, fistula, stenosis, granuloma, folli-

culitis, trauma, hemorrhage, and chronic dermatitis.6

In the authors’ opinions, this approach is not

acceptable for the classification of peristomal compli-

cations. Ostomy care professionals need a peristomal

September 2007 Vol. 53 Issue 9 39

KEY POINTS• Peristomal skin complications are a serious concern because they

affect the ability to manage the stoma and maintain a securepouching system which, in turn, can cause more serious problemsand complications.

• The authors report that, after assessing more than 600 patients dur-ing a 2-year study, more than half of all patients were found to haveperistomal skin problems.

• Using the data collected and photographs obtained, they classifiedthe lesions based on clinical presentation and location.

• The resultant instrument was found to be easy to use and additionalstudies to further refine and validate this standardized instrumentare warranted.

Ostomy Wound Management 2007;53(9):38–43

Figure 1. Data collection form.

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skin lesion stage classification that is universally

recognized and shared to facilitate lesion interpreta-

tion and detection that includes topography. This

classification could be a standardized and objective

tool useful for a proper monitoring and follow-up

of complications. A study group — Studio osser-

vazionale multicentrico sulle alterazioni cutanee

post-enterostomie (Study on Peristomal Skin

Disorders [SACS]) — comprised of seven

Enterostomal Therapy (ET) nurses and four sur-

geons from eight facilities was created to: 1) study

and classify skin disorders secondary to the creation

of an enterostomy and, 2) determine, through the

analysis of blood chemistry and clinical parameters,

if a correlation exists between the severity of peris-

tomal skin lesions and clinical metabolic disorders.

This report shows results relevant to the first study

objective — namely, the classification of peristomal

skin disorders.

Materials and MethodsTime and setting. A prospective, observational

study was conducted between December 2003 and

February 2006. The eight national ostomy centers par-

ticipating in this clinical study were located uniformly

across Italy in order to prevent a possible geographic

or environmental bias.

Patients. All enterostomy patients who accessed the

participating clinics during the observation period

were evaluated. The Ethics Committee of each partic-

ipating hospital approved the study and all patients

read and signed a written informed consent in com-

pliance with privacy regulations.

Patients were assigned to one of two observational

arms of the study according to the time elapsed since

surgery (Group 1: <1 year; Group 2: >1 year) to differ-

entiate between early and late skin lesions. Skin lesions

were examined at set intervals (weeks 0, 4, 12, 24) and

their changes noted over time by clinical observation

40 OstomyWound Management

TABLE 1PATIENT DEMOGRAPHICS GROUP 1

<1 YEAR AFTER SURGERY(N = 380)

VariableGender (%)

Age (years)

Stoma type (%)IleostomyColostomy

Permanent stoma Temporary stoma Chemotherapy Clinical assessment (Number per month)

Time following surgery(months)

Systemic disease

Male: 60Female: 40Mean (SD): 62.99 (13.978)Minimum: 25Maximum: 85

28.671.462.6%37.8%30%Mean (SD): 3.04 (2.295)Minimum: 1Maximum: 12Mean (SD): 3.33 (2.517)Minimum: 1Maximum: 6Cardiopathy: 9.1%Arterial hypertension: 8%Diabetes: 11.2 %

TABLE 2PATIENT DEMOGRAPHICS GROUP 2

>1 YEAR FOLLOWING SURGERY(N = 276)

VariableGender (%)

Age (years)

Stoma type (%)IleostomyColostomy

Permanent stoma Temporary stoma Chemotherapy Clinical assessment (Number per month)

Time following surgery(months)

Systemic disease

Male: 65Female: 35Mean (SD): 65.19 (13.957)Minimum: 26Maximum: 91

31.9%68.1%87.5%12.5%36%Mean (SD): 1.30 (0.628)Minimum: 1Maximum: 4Mean (SD): 41.91 (44.204)Minimum: 8Maximum: 320Cardiopathy: 4.2%Arterial hypertension: 8%Diabetes: 11%

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and the acquisition of digital images. Blood chemistry

was obtained as part of routine postoperative proce-

dure because the results may be suggestive of tissue

proliferation and regeneration factors. Laboratory val-

ues including blood glucose, iron, and hemoglobin

levels, as well as patient weight and stoma variables

such as burning, itching, pain, and bleeding, were

recorded in the electronic data entry form provided to

participating centers (see Figure 1).

Procedure. At the end of the 24-week observa-

tional period, study group members (the experts

from the eight participating ostomy centers)

attempted to validate the early/late classification

system. During three consensus conferences, the

expert panel developed and unanimously accepted

the classification definitions based on their clinical

observations and knowledge of the mechanisms of

peristomal skin injury.

After the classification definitions were accepted,

the first task was to examine and validate classifica-

tion of the 800 digital images of injuries representa-

tive of all different typologies of injuries and topog-

raphy that were contributed by the participating

centers. After three additional consensus confer-

ences, a common and shared criterion for the classi-

fication of the 800 images was achieved. Each com-

ponent of the study group agreed on how the images

were to be classified and that the classification sys-

tem accurately classified the images. Subsequently,

in order to enhance the reproducibility and objectiv-

ity of the classification, a multiple-choice question-

naire was sent via email to four experts outside the

study group (two surgeons and two ET nurses) with

experience in the field. They were asked to classify 20

images of injuries using the draft classification

scheme accompanying the questionnaire. The results

September 2007 Vol. 53 Issue 9 41

Figure 2. Final classification, definition of each type of lesion, topography, and pictorial representation of lesion.

Definition and Classification of Peristomal Skin DisordersLesion (L)L1 Hyperemic lesion (peristomal skin reddening without loss of substance)L2 Erosive lesion with loss of substance not extending beyond the dermisL3 Ulcerative lesion extending beyond the dermisL4 Ulcerative fibrinous/necrotic lesionLX Proliferative lesions (granulomas, oxalate deposits, neoplasm)

Topography (T)I = upper leftII = upper rightIII = lower rightIV = lower leftV = total

Example:

L1 TV

Topography (T) of peristomal skin disorders

The definition of localization of each quadrant around thestoma in the abdomen region.

Ostomy

I II

IIIIV

L2 TV L3 TIII, IV L3 TIII, IV LX TV

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of the questionnaire were analyzed by a clinician

coordinating responses.

Data analysis. Descriptive statistical analyses were

conducted using the software SPSS 14.0 (SPSS,

Chicago, Ill).

ResultsBy the end of the study period, 656 ostomy patients

had been observed: 380 in Group 1 — early complica-

tions — and 276 in Group 2 — late complications. Of

all patients observed, 70% had colostomies; of these,

65% had undergone a Miles’ procedure.7 The remain-

ing 30% of observed patients had ileostomies. Of all

patients observed, 339 patients (52%, 272 men and 67

women) had peristomal skin disorders and were

therefore included in the study for the development of

the classification scheme. Group 1 comprised 194

patients (51%, average age 63, range 25 to 85) and

group 2 included 145 patients (52%, average age 65,

range 26 to 91). Of all patients observed in Group 1

and Group 2, 30% and 36.1%, respectively, were

receiving adjuvant chemotherapy (see Table 1 and

Table 2). The laboratory data collected are not part of

this report but will be used for the analysis of the sec-

ond endpoint in future report.

After reviewing and classifying all the images,

five lesions (L) were most commonly observed (see

Figure 2).

The peristomal complication classification system

developers agreed to identify the quadrants around

the stoma in a manner similar to the system used for

breast cancer patients to facilitate topographical

description of the lesions (see Figure 2).

Using recurrent clinical manifestations (L) and

topographical location (T), the most frequently

observed lesion in both Groups was L1 (a hyperemic

lesion) followed by L2 (an erosive lesion) (see Table 3

and Table 4). Classification as “intact” indicated the

absence of lesions on peristomal skin.

The subsequent validation study results of the non-

study group members validated the classification sys-

tem. The validity of classification was measured by

reporting agreement among diagnoses; strength of

agreement was rated “very good” (K value = 0.91).

Once it was ascertained that the classification system

was a helpful tool, a pocket ruler guide for the classifi-

cation was created to provide a brief summary and

practical explanation on the classification system to be

used by ET nurses in daily work.

As mentioned previously, the information obtained

from the blood samples includes 10,848 bits of clinical

and blood chemistry data and will be used by the

SACS study group to investigate the possible correla-

tion of blood test results with the severity of peristom-

al skin lesions. This study is ongoing.

DiscussionAlthough relevant literature was replete with

descriptions of clinical pictures of irritative manifesta-

tions of the peristomal skin,9,10 an objective, clinical,

easy-to-interpret classification of peristomal lesions

was lacking. This is the first large-sample study to

identify a simplistic, rapid way to document peristom-

al lesion change over time and provide an ability for

healthcare personnel to compare and discuss lesion

change. This classification instrument was not only

developed but also validated to allow future use and

42 OstomyWound Management

TABLE 3PERCENTAGE OF LESIONS IDENTIFIED GROUP 1: <1 YEAR FROM SURGERY

Type of lesionintact1234x

N1319161182212

%39%27%18%5%7%4%

TABLE 4PERCENTAGE OF LESIONS IDENTIFIEDGROUP 2: >1 YEAR FROM SURGERY

Type of lesionintact1234x

N12579454

1016

%45%28%16%1%4%6%

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September 2007 Vol. 53 Issue 9 43

study, as well as results, to be repeated by other clini-

cians. The parameters for classification (L and T) facil-

itate postsurgical assessment of lesions in a non-sub-

jective, reproducible way. Incidentally, study data

include a large sample of incidence and prevalence

data of peristomal skin conditions. The study repre-

sents the first-time availability of a standardized clas-

sification system that is not based on individual opin-

ion. Having a universal definition of peristomal com-

plications offers clinicians a way to report and moni-

tor complications — an important and effective tool

for enterostomal therapists playing a pivotal role in

the management of peristomal disorders.

ConclusionsImproving and maintaining the integrity of peris-

tomal skin is an important objective for both ostomy

patients and ostomy care professionals. Peristomal skin

integrity plays a fundamental role in the improvement

of quality of life of a patient with an abdominal ostomy.

Having a way to classify peristomal skin disorders pro-

vides a tool for an objective assessment that, in turn,

offers a new guideline for the correct interpretation and

diagnosis of skin disorders. Additionally, the pocket

ruler guide for peristomal skin disorder classification

enhances the practicability of the guidelines.

The quality of professional service always must be

supported by scientific research and professional

ethics. An objective classification system is fundamen-

tal to proper diagnosis and characterization of peris-

tomal skin disorders, standardization of terminology,

and incidence or prevalence studies.

Furthermore, this classification scheme could be

used to help identify mechanisms and biomarkers

associated with the various classes of peristomal skin

complications — topics for further research. - OWM

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standard diversion. J WOCN. 2001;28(1):6–17.2. Arumugam PJ, Bevan L, Macdonald L, et al. A

prospective audit of stomas-analysis of risk factorsand complications and their management. ColorectalDis. 2003; 5(1):49–52.

3. Hampton B. Peristomal and stomal complications.In: Hampton B, Bryant R, eds. Ostomies andContinent Diversions: Nursing Management. St.Louis, Mo.: Mosby;1992:105–123.

4. Lyon CC, Beck MH. Dermatological problems instoma patients. Br J Dermatol. 1999;140:536.

5. Rolstad BS, Erwin-Toth PL. Peristomal skin compli-cations: prevention and management. OstomyWound Manage. 2004;50 (9):68–77.

6. Lyon CC, Smith AJ. Abdominal Stomas and TheirSkin Disorders. An Atlas of Diagnosis andManagement. London, UK. Martin Dunitz Ltd; 2001.

7. Miles WE. A method of performing abdominoper-ineal excision for carcinoma of the rectum and theterminal portion of the pelvic colon. Brit Med J.1908;2:1812–1814.

8. Veronesi U, Saccozzi R, Del Vecchio M, et al.Comparing radical mastectomy with quadrantecto-my, axillary dissection, and radiotherapy in patientswith small cancers of the breast. N Engl J Med.1981;305(1):6–11.

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

10. Marquis P, Marrel A, Jambon B. Quality of life inpatients with stomas: the Montreux study. OstomyWound Manage. 2003;49(2):48–55.

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