Lessons Learned About Peristomal Skin Complications: Secondary Analysis of the ADVOCATE Trial

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, χ 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.