Application and Efficacy Evaluation of a Modified Ostomy Appliance in Managing Peristomal Irritant Contact Dermatitis: A Randomised Controlled Trial

Irritant contact dermatitis is a common peristomal skin complication. Due to the continuous irritation from intestinal fluids and faeces, the healing of this dermatitis is slow and the condition severely impairs patients' quality of life. The study aimed to evaluate the efficacy of a modified insertable ostomy appliance in promoting healing and improving patient outcomes. A randomised controlled trial was conducted from January 2022 to December 2024 in a tertiary hospital. The enrolled patients, all diagnosed with irritant contact dermatitis, were randomly assigned to two groups. The control group wore the conventional two-piece ostomy appliance, while the experimental group wore the modified insertable ostomy appliance. Outcomes were assessed on Days 3, 7, 14 and 28. The primary outcome was the healing rate (Discoloration, Erosion and Tissue overgrowth [DET] score ≤ 2) at Day 28. Secondary outcomes included the DET score, Visual Analogue Scale (VAS) pain score, Stoma Quality of Life questionnaire (Stoma-QOL) score and the incidence of appliance leakage. A total of 89 eligible participants completed the trial. The experimental group showed a significantly higher 28-day healing rate (73.3% vs. 29.5%, p < 0.001), lower DET scores (Day 28: 2.0 vs. 4.5, p < 0.001), reduced VAS scores (Day 28: 1.5 vs. 2.0, p < 0.001), higher Stoma-QOL scores (Day 28: 55.67 vs. 51.64, p < 0.001) and lower leakage rate (13.3% vs. 93.2%, p < 0.001). The modified ostomy appliance significantly improves healing, reduces pain and enhances quality of life, representing a novel solution for clinical practice.