Evaluation of Off-Label Use of Sucralfate Suspension for the Treatment of Irritant Contact Dermatitis in Patients with Stoma

Abstract

Irritant Contact Dermatitis (ICD) is a common complication among stoma patients. Sucralfate has been shown to form a protective barrier over irritated skin and stimulate the production of growth factors such as Fibroblast Growth Factor (FGF) and Epidermal Growth Factor (EGF), thereby accelerating tissue regeneration. In Indonesia, sucralfate suspension is frequently used off-label as a topical agent for ICD management. This study aimed to evaluate the effectiveness of topical sucralfate suspension + NaCl 0.9% therapy compared with NaCl 0.9% only in improving clinical outcomes in stoma patients with ICD. A retrospective study was conducted using medical records from RSPAU dr. Suhardi Hardjolukito, Yogyakarta, between March 2023 and March 2025. Among 66 stoma patients identified, 50 met the inclusion criteria (25 received sucralfate + NaCl 0.9% and 25 received NaCl 0.9% only). Clinical outcomes included changes in skin irritation and pain reduction (ΔVAS) from day 1 to day 3. Additional variables such as age, sex, comorbidities, type of stoma, albumin level, and leukocyte count were analyzed using Chi-Square tests. The sucralfate group demonstrated significantly greater pain reduction (ΔVAS = 0.88 ± 0.881; p = 0.003) and a higher rate of irritation improvement (84% vs 56%; p = 0.031; COR = 4.125; 95% CI: 1.092–15.585). In conclusion, off-label sucralfate provides better clinical outcomes in treating ICD, so it can be considered as an alternative therapy for patients.