Lessons Learned About Peristomal Skin Complications: Secondary Analysis of the ADVOCATE Trial : Journal of Wound Ostomy & Continence Nursing

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Ostomy Care

Lessons Learned About Peristomal Skin Complications

Secondary Analysis of the ADVOCATE Trial

Salvadalena, Ginger; Colwell, Janice C.; Skountrianos, George; Pittman, Joyce

Author Information
Journal of Wound, Ostomy and Continence Nursing 47(4):p 357-363, July/August 2020. | DOI: 10.1097/WON.0000000000000666
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The aims of this study were to (1) describe the demographic and clinical characteristics of the individuals with peristomal skin complications (PSCs); (2) describe the PSCs; (3) examine the relationship of PSC occurrence and severity with possible risk factors, and (4) describe how PSCs were managed clinically.


Secondary analysis of data from randomized controlled study, the ADVOCATE trial.


Study participants (n = 153) were divided into 2 groups: those who did not experience a PSC (n = 80) and those who did (n = 73). A participant was considered to have sustained a PSC during the original study if his or her Discoloration, Erosion, and Tissue score increased above the baseline score.


Demographic and pertinent characteristics of participants with and without PSCs were compared. In addition, data from the 73 participants who sustained PSCs were further analyzed to characterize and describe the PSCs, to investigate potential risk factors associated with the occurrence and severity of a PSC, and for clinical management. Group comparisons were made via t tests for continuous variables, χ2 test or Fisher exact test for categorical variables, and generalized linear models for identification of risk factors.


The majority of the PSCs were mild or moderate in nature, and they were most commonly categorized by the investigators as irritant dermatitis. Two risk factors were associated with an increased likelihood of experiencing a PSC: stoma duration and peristomal skinfold or creases. Within the study period, the odds of sustaining a PSC increased over time and the presence of skinfolds or creases increased the likelihood of PSCs. Peristomal skin complication severity was likely to be worse with an ileostomy and less severe as stoma duration increased. Products used to manage PSCs consisted of barrier rings/seals, skin barrier powder, and paste or paste strips.


Ileostomy is associated with higher risk of a severe PSC and peristomal skin creases or folds. Patient follow-up should be on a structured schedule beyond the first few weeks after surgery because the likelihood of getting a PSC increases over time. This approach may help improve outcomes, particularly for those with an ileostomy and challenging skin contours.


Ostomy surgery can be lifesaving or alleviate severe morbidity associated with multiple conditions, but it can also create difficulties. Up to 80% of patients experience ostomy complications; the most common affect the peristomal skin.1–6 Peristomal skin complications (PSCs) are defined as skin inflammation, injury, or damage that occurs within the 3 to 4 in of skin surface surrounding an abdominal stoma or skin covered by the adhesive portion of the pouching system (skin barrier and tape). Incidence of PSCs has been reported as high as 75%.6–8

Peristomal skin complications can be caused by a variety of factors: mechanical, chemical, infectious, and systemic health conditions.9 A common cause of PSCs is peristomal moisture–associated damage (PMASD), often resulting from exposure of the skin to stoma effluent.10 Mechanical factors include peristomal medical adhesive–related skin injury that occurs with removal of adhesive pouching systems.11,12 Regardless of the cause, PSCs significantly impact patients' lives and can lead to pain, reduced life satisfaction and social interactions, and increased health care costs.1,3,6,9,13–15 The development of PSCs during the 120-day period following stoma formation is associated with hospital readmission and longer lengths of hospital stay.16,17

There are limited prospective studies related to ostomies and even fewer examining PSCs. In 2018, Colwell and colleagues18 reported results of a multicentered, international, double-blinded randomized controlled trial examining the effect of a ceramide-infused skin barrier on cost and PSCs as compared to standard skin barrier (ADVOCATE trial). The ADVOCATE trial enrolled 153 adults from 25 sites from the United States, Canada, and Europe. Participants were seen in hospital and outpatient care settings. Study subjects had normal skin (free of PSC) at baseline and they were followed for up to 12 weeks. Visual assessment of the stoma and peristomal skin was performed at each visit using the Ostomy Skin Tool19,20 evaluating the presence and extent of discoloration, erosion, and tissue overgrowth. Photographs were used to verify visual assessments among the sites and for quality assurance.

The incidence of PSCs was 47.7% (73 of 153); 40.5% in the ceramide-infused skin barrier, and 55.4% in the control group (P = .069). The purpose of this study was to further examine the ADVOCATE findings and describe more about those PSCs that developed and those that resolved. Specifically, our aims were to (1) describe the demographic and clinical characteristics of the individuals with PSCs; (2) describe the PSCs; (3) examine the relationship between PSC occurrence and severity with possible risk factors, and (4) describe how the PSCs were managed clinically.


Data from all study participants who sustained a PSC during the ADVOCATE trial were used in this post hoc analysis. Participants were enrolled into the ADVOCATE trial within 12 weeks of stoma creation and had healthy skin at the time of enrollment. Full details about the study were described previously.18

Briefly, participants were recruited by WOC nurses at 25 settings in the United States, Canada, and Europe. Participants were randomly allocated to a standard or ceramide-infused skin barrier. Participants were followed over the next 8 to 12 weeks and data collection occurred up to 5 times over the study period: once per month if the skin remained healthy and every 14 days for 2 weeks after a PSC occurred. Study investigators recorded the number and shape of skin barriers worn by study participants and listed all products the participants used for ostomy care. At each study visit, the participant was placed in a sitting position, and a WOC nurse removed the pouching system and evaluated the skin and peristomal contours. The Discoloration, Erosion, and Tissue (DET) score from the Ostomy Skin Tool was used to measure peristomal skin condition. Within each domain (discoloration, erosion, and tissue overgrowth), the percentage of the peristomal skin affected and the severity of the skin change was assigned a score, with the total score ranging from 0 to 15; higher DET scores reflect more skin area affected and higher severity of the PSC.19,20 The severity of a PSC was classified as mild, moderate, or severe based on a taxonomy described by Martins and associates.20 A participant was considered to have sustained a PSC during the study if his or her DET score increased 1 point above the baseline value at any study visit; 3 additional study visits were then scheduled 2 weeks apart to assess the PSC for changes. A PSC was deemed resolved when the DET score returned to the participant's baseline value. The WOC nurse investigators recorded the actions they took to improve product fit (such as changing a patient from flat barriers to convex barriers, or resizing the barrier opening, use of accessory products), as well as recommendation for barrier change frequency and addition of products for topical skin care.

Participants rated their peristomal skin condition on a scale from normal/nonirritated to severely blistered or damaged at their final study visit. Correlating these 2 assessments enabled ranking of levels of agreement between clinicians and participants.

Data Analysis

Continuous variables (eg, participant age, stoma duration, body mass index) were summarized via measures of central tendency (average) and variability (standard deviation). Categorical variables (participant sex, ostomy type, stoma construction) were summarized as frequency counts and percentages. Group differences were analyzed via t tests (for continuous variables), χ2 test or Fisher exact test (for categorical variables), and generalized linear models (for the investigation of risk factors). For the comparison of demographic and stoma characteristics, study participants were divided into 2 groups: those who did not experience a PSC versus those who did. Data from participants who sustained PSCs were then further analyzed to characterize the PSCs and to investigate potential risk factors associated with the occurrence and severity of a PSC.

To investigate potential risk factors associated with the likelihood to experience a PSC, a logistic regression was performed with the occurrence of a PSC as the event of interest controlled for the following participant risk factors: sex, diagnosis of diabetes, age, body mass index, reason for ostomy surgery, ostomy type, stoma protrusion, stoma duration (in weeks), presence of skinfolds/creases in peristomal area, and stoma construction. Furthermore, to control for the effects of the ostomy barrier on the peristomal skin, a barrier variable (ceramide-infused barrier vs control) was included in the regression model. To investigate the association of the aforementioned risk factors with the severity of a PSC, a proportional odds model was used with PSC severity categorized as mild, moderate, and severe.


The results are presented in order of the objectives (description of the study participants with PSCs, characteristics of PSCs, followed by risk factors and finally, the methods used to manage PSCs). Table 1 summarizes demographic characteristics of 153 participants. There were no statistical differences in the measured participants demographics and the reasons for ostomy surgery between those who sustained PSCs and those who did not. Table 2 summarizes stoma characteristics and peristomal topography reported for the 2 groups of participants (those who did not experience a PSC [n = 80] and those who did [n = 73]). No statistical differences were found on any of the measured variables between the groups with and without PSCs. The majority of stomas were round or oval in both groups and the mean stoma diameter was 33 mm. Thirty-one subjects (20%) had peristomal skin creases.

TABLE 1. - Demographics of Study Participants
Number of subjects 80 73
Sex, n (%)

49 (61)
31 (39)

44 (60)
29 (40)
Does the subject have diabetes? n (%)

69 (86)
11 (14)

67 (92)
6 (8)
Reason for ostomy surgery n (%)a
Bowel cancer
Bladder cancer
Crohn's disease
Ulcerative colitis
Familial polyposis
Intestinal obstruction and/or perforation

29 (36.3)
8 (10.0)
9 (11.3)
8 (10.0)
1 (1.3)
7 (8.8)
0 (0.0)
8 (10.0)
14 (17.5)

36 (49.3)
4 (5.5)
4 (5.5)
8 (11.0)
0 (0.0)
11 (15.1)
1 (1.4)
5 (6.8)
10 (13.7)
Mean ± SD (Range) Mean ± SD (Range)
Age, y 56.4 ± 16.4
56.2 ± 14.2
BMI 25 ± 6.0
26 ± 6.5
Abbreviations: BMI, body mass index; n/a, not applicable; PSC, peristomal skin complication.
aMultiple responses were allowed.
bP value not calculated; clinical variable was statistically assessed as a risk factor.

TABLE 2. - Stoma Characteristics and Peristomal Topography
Number of subjects 80 73
Ostomy type, n (%)

46 (57.4)
25 (31.3)
9 (11.3)

35 (48.0)
33 (45.2)
5 (6.8)
Stoma construction, n (%)
End/loop or double-barrel

63 (78.8)
14 (17.4)
3 (3.8)

47 (64.4)
21 (28.8)
5 (6.8)
Stoma shape, n (%)

3 (3.8)
34 (42.4)
43 (53.8)

1 (1.4)
37 (50.7)
35 (47.9)
The stoma, n (%)
Is flush/flat
Is protruding/budded
Is recessed or other

13 (16.25)
65 (81.25)
2 (2.50)

6 (8.2)
66 (90.4)
1 (1.4)
Parastomal hernia, n (%)

79 (98.7)
1 (1.3)

71 (97.3)
2 (2.7)
Peristomal topography (when assessed in the sitting position) n (%)a
Skin creases in peristomal skin
Fat folds in peristomal skin
Round abdomen
Flat abdomen
Soft abdomen
Firm abdomen

7 (8.8)
5 (6.3)
35 (43.8)
37 (46.3)
42 (52.5)
6 (7.5)
1 (1.3)

24 (32.9)
7 (9.6)
33 (45.2)
26 (35.6)
33 (45.2)
11 (15.1)
0 (0.0)
Mean ± SD (Range) Mean ± SD (Range)
Stoma duration at baseline, wk 5.6 ± 3.6
4.5 ± 3.4
Diameter of stoma at baseline, mm 33.1 ± 8.2
33.1 ± 11.5
Abbreviations: n/a, not applicable; PSC, peristomal skin complication.
aMultiple responses were allowed.
bP value not calculated; clinical variable was statistically assessed as a risk factor.

Peristomal Skin Complications

On average, participants experienced their PSC 64 days after undergoing stoma surgery (SD = 29.8 days; range: 16-132 days). Furthermore, 19 of 73 participants (26%) had skin creases/fat folds in their peristomal region at the time of PSC occurrence. In addition, more than half of these participants were using convex skin barriers (n = 10, 53%). A description of the PSCs present at the time of the evaluation is presented in Table 3. Site investigators selected from a list of commonly used terms to categorize the PSCs by type, as shown in Table 3; the 3 most common types of PSCs were acute or chronic irritant dermatitis (PMASD), maceration, and mechanical trauma. Table 4 presents PSC severity and time to resolution. Using previously published recommendations, severities were grouped into mild (1-3), moderate (4-6), and severe (7-15).14 Thirty-two subjects experienced a mild PSC (44%), 35 (48%) were moderate, and 6 (8%) were severe. The average DET score for the 73 participants was 3.1 (SD = 1.7; range: 0-9); 50% of the scores were between 2 and 4 (categorized as mild). Representative images are shown in the Figure. Twenty-nine of the 73 (40%) PSCs resolved within the study period. The average time from PSC occurrence to PSC resolution was 23.6 days (SD = 10.3; range: 9-42 days). None of the 6 severe PSCs (DET score: 7-15) resolved prior to the final study visit.

Examples of peristomal skin complications categorized by the DET score as mild, moderate, and severe. DET indicates Discoloration, Erosion, and Tissue.
TABLE 3. - Peristomal Skin Complicationsa
n (%)
Irritant dermatitis 37 (50.7)
Maceration 15 (20.5)
Mechanical trauma 12 (16.4)
Folliculitis 3 (4.1)
Mucocutaneous separation 3 (4.1)
Suture granuloma 1 (1.4)
Excess tissue 1 (1.4)
Pressure injury 1 (1.4)
Pyoderma gangrenosum 1 (1.4)
Unknown 1 (1.4)
Fungal rash/infection 1 (1.4)
Skin infection 1 (1.4)
Product sensitivity/allergy 0 (0.0)
aMore than 1 response allowed.

TABLE 4. - PSC Severity and Resolution
PSC Severity No. PSCs Occurred No. PSCs Resolved Days to PSC Resolution (From Occurrence)
Mean SD Median 25th Quartile 75th Quartile
Mild (1-3) 32 11 23.0 10.2 22.0 14.0 34.0
Moderate (4-6) 35 18 23.9 10.7 21.0 14.0 33.0
Severe (7-15) 6 0 ... ... ... ... ...
Overall 73 29 23.6 10.3 21.0 14.0 33.0
Abbreviation: PSC, peristomal skin complication.

One hundred fourteen of 153 subjects (75%) provided self-assessments of their peristomal skin at their final study visit; 39 discontinued the study prior to the final visit without providing a self-assessment. The majority of participants (81 of 114 or 71%) indicated that their peristomal skin appeared normal. Twenty-nine participants (29 of 114, 25%) reported their skin as slightly reddened and the remaining 4 participants indicated that their peristomal skin was severely reddened or slightly blistered. None of the participants reported that their skin was severely blistered. We observed no apparent differences between participants' self-assessment and that provided by their WOC nurses. Specifically, participants who reported normal/nonirritated skin had an average DET score of 0.65 and participants reporting slight redness had an average DET score of 2.3. The mean DET score was 6 to 6.5 for those reporting severely reddened or slightly blistered peristomal skin.

Risk Factors

Logistic regression analysis found 2 factors associated with a higher likelihood of a PSC: peristomal creases and/or fat folds and time since stoma creation. Participants with skin creases in their peristomal area were approximately 3 times more likely to experience a PSC than those who had no creases (odds ratio [OR] = 2.9, 95% confidence interval [CI]: 1.3-8.1). Furthermore, the likelihood of experiencing a PSC increased by 24% for every 1-week increase in stoma duration (OR = 1.24, 95% CI: 1.13-1.39).

Peristomal skin complication severity was associated with stoma type and stoma duration. Participants with an ileostomy were approximately 10 times more likely to experience a more severe PSC than participants with a colostomy (OR = 9.8, 95% CI: 2.2-43.7). There were no differences between other stoma types. The severity of new PSCs, regardless of ostomy type, changed inversely with time, that is, the longer it had been since surgery, the less severe the PSC when it did occur.

Management of PSCs

The protocol for the ADVOCATE trial incorporated 2 follow-up visits 2 weeks apart following a PSC. Twenty-nine participants (40%) experienced resolution of their PSC within 4 weeks of occurrence; the PSCs in the remaining 44 (60%) participants did not resolve within the 4-week follow-up period. Table 5 presents the health care resources (products and services) used by participants with a PSC. The 3 most common accessories used in PSC management were barrier rings, skin barrier powder, and adhesive remover. The majority of participants remained in the same barrier shape after PSC occurrence. Five participants were switched from a convex barrier to a flat barrier; 7 participants were switched from flat to convex.

TABLE 5. - Health Care Resources (Products and Services) Used to Manage PSCs
Resource PSC, n (%)
Rings/seals (flat or convex) 43 (58.9)
Ostomy powder 36 (49.3)
Adhesive remover 27 (37.0)
Paste/paste strips 26 (35.6)
Skin film wipe or spray 25 (34.2)
Other (eg, adhesive spray) 19 (26.0)
Ostomy belt 13 (17.8)
Health care provider visits 15 (20.5)
Antibiotic (oral, intravenous, or topical) 7 (9.6)
Antifungal powder usage 3 (4.1)
Ostomy tape 3 (4.1)
Topical steroid 2 (2.7)
Flange extenders 1 (1.4)
Abbreviation: PSC, peristomal skin complication.

The most common clinician recommendation for the management of a new ostomy was to change the skin barrier every 3 to 4 days, regardless of whether a PSC was present. These recommendations did not change during subsequent study visits, even if a PSC occurred. Participants without PSCs wore an average of 3.2 barriers per week (2.2 days between changes). Similarly, the 73 subjects in the PSC group wore an average of 3.0 barriers per week (2.3 days). In both groups, participants wore barriers for a shorter period than the wear time recommended by their clinician.


Findings from this secondary analysis add to our knowledge of the characteristics of PSC in patients with new ostomies, their severity, and the potential to design preventive interventions based on research-based risk factors. In the original trial, the rate of PSC was lower in the group using the ceramide-infused skin barrier versus the standard skin barrier (40.5% vs 55.4%).18 Several prior authors have reported higher PSC rates. Pittman and colleagues1 reported a 50% PSC prevalence in follow-up visits conducted 30 to 60 days after surgery. In another prospective study, PSCs developed in 27 (63%) of patients; most occurred 21 to 40 days after ostomy surgery.5 Using a retrospective design, Nagano and colleagues21 found that 51% of 89 subjects developed PMASD (the most common category of PSC) 8 weeks after surgery for colorectal cancer. In a cross-sectional survey of 38 respondents, 76% reported having experienced peristomal skin irritation.4

The timing of PSC occurrence was 64 days in our analysis, longer than prior reports; however, because enrollment was allowed up to 12 weeks after surgery, it is possible that some participants had already experienced (and resolved) a PSC before their first visit. All investigators were skilled in ostomy care from carefully selected sites, trained in study procedures, and monitored regularly for adherence to study procedures. The investigators provided evidence-based practices with regard to product fit, sizing, and frequency of participant follow-up. Despite excellent care and structured follow-up, PSCs occurred in about half of the study participants, justifying the need for WOC nursing care beyond the period of hospitalization.

The most commonly occurring peristomal complication was irritant dermatitis, reported in 50.7% of individuals (n = 37) who developed a PSC. A form of PMASD, irritant dermatitis is damage resulting from skin exposure to fecal or urinary drainage or chemical preparations. It has been previously reported as the most common type of PSC.22 Similarly, mechanical trauma (peristomal medical adhesive–related skin injury) was found in 16.4% (n = 12) of the subjects with PSCs, consistent with findings in prior reports.11,12 The authors of 2 recent studies presented comparative analyses of the impact of removal of adhesive skin barriers on the condition of the epidermis underscoring the importance of intentional barrier selection to reduce peristomal medical adhesive–related skin injury risk.23,24

Analysis revealed that 29 of 73 participants (40%) experienced resolution of their PSC within 4 weeks. Nevertheless, the average time to resolution (23.6 days) was longer than anticipated, given the mild to moderate categories of DET skin scores. Limited research has been conducted on interventions for PSCs; the existing information comes from clinical practice and anecdotal experience. Investigators in the original study used a variety of products to manage PSCs. The most common accessory product usage was rings/seals used in 43 (59%). Skin barrier powder was second most common, consistent with current practices of using powder to absorb moisture from the injured area.2 An adhesive remover was used with 37.0% of individuals, followed by paste and paste strips (35.6%); these measures are commonly used to help secure an appropriate fit for the pouching system. Liquid skin barrier products were used in 34.2% of the treatment of PSC, consistent with the practice of using it over barrier powder or to provide a protective covering to the peristomal skin.

Peristomal topography (specifically, peristomal creases) and stoma duration were associated with an increased likelihood to develop a PSC. Based on this finding, we recommend a thorough assessment of the peristomal skin in sitting and standing positions to determine the need for a convex product or accessories to enhance the skin barrier seal by exposing folds and creases not easily seen when the patient is supine. Findings also suggest that the likelihood for PSCs increases over time; we, therefore, recommend patient follow-up on a structured schedule beyond the first few weeks after surgery. We also recommend additional study to determine the best times for structured follow-up following ostomy surgery.

We examined a variety of other factors (sex, concurrent diabetes mellitus, age, body mass index, reason for ostomy surgery, stoma protrusion, and stoma construction) but none emerged as risk factors for PSC on multivariate analysis. However, analysis did reveal that participants with an ileostomy were at greater risk to experience more severe PSCs than participants with a colostomy; this finding is consistent with the premise that moisture-associated skin damage occurs most commonly with exposure to liquid fecal effluent from ileostomy.10,22 Few also observed that as stoma duration increased, the risk of experiencing a more severe PSC decreased. While the 2 findings on stoma duration may seem contradictory, the data suggest that the longer the participants were followed, the more likely they were to experience a PSC but when one occurred, it would be less severe in nature. Participants in the original study had an ostomy created less than 12 weeks at baseline assessment; thus, generalizability to a broader population is limited.

Our findings are similar in part to those reported by Nagano's group.21 By applying the logistic regression model they reported, participants who underwent chemotherapy during study follow-up were 2.9 times more likely to experience a PSC (OR = 2.9, 95% CI: 1.3-6.8). We did not find an association between ostomy types (fecal and urinary) and PSC occurrence. This may be because a PSC in the current analysis was more generally defined (eg, PMASD was one of many complications). For patients undergoing chemotherapy, the plan of care should include patient education about PMASD and the need to follow up with their health care provider for ongoing assessment of peristomal skin integrity.

Several findings were unique to this analysis and warrant further study. The wear time (time between pouch application and removal) recommended by site investigators in the original study varied based on site location.18 It was 3 to 4 days in North America while European recommendations were equally split between 1- and 2-day wear times versus 3- and 4-day times. Regardless of recommendations, study participants wore their pouching systems for less time than recommended by their providers. The reason for this discrepancy is unknown and deserves additional study.

We found that the majority of participants and providers rated the condition of their peristomal skin similarly when we compared patient self-assessment and clinician DET scores during the final study visit. This is in contrast to the findings of Herlufsen and collegues,25 who found an agreement level of just 36%. These disparate results may be due to the differences between the 2 study methods and the timing of the assessments. Participants who described their skin as “normal” often had peristomal redness as assessed by the study investigators. This suggests that participants expect redness perhaps and underscores the importance of patient education about peristomal skin health.


The ADVOCATE trial was powered to detect differences in PSC-related costs in patients randomly allocated to use of a ceramide-infused versus standard faceplate. As a result, findings from this secondary analysis cannot be used to conclusively evaluate the efficacy of specific interventions for prevention or treatment of PSCs. In addition, our sample size does not allow a robust study of the epidemiology of PSC following ostomy surgery. Additional studies evaluating the efficacy of preventive and management interventions for PSC are needed.


We found 2 risk factors significantly correlated with the likelihood of developing a PSC: stoma duration and peristomal creases. Findings from this secondary analysis suggest that multiple interventions are important for the prevention of PSC. For example, careful selection of an optimal location for the stoma is essential to help prevent placement in a skinfold. Study findings also clearly point out the need for routine postoperative follow-up by a skilled stoma care nurse; our results indicate that the risk of PSC continues beyond the first few months, albeit with lowered PSC severity over time. An individualized plan of follow-up for patients, prompt intervention for those with pouching fit problems, and the addition of specific protective measures with ileostomy will help ensure early problem identification and treatment.


This work was made possible by the many clinical investigators and participants in the ADVOCATE Study.


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Colostomy; Ileostomy; Ostomy; Peristomal skin complications; Peristomal topography; Risk factors and stoma duration; Stoma; Urostomy

© 2020 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the Wound, Ostomy and Continence Nurses Society