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Protease Enzyme Inhibitor Cream for the Prevention of Diaper Dermatitis After Gastrointestinal Surgery in Children: Lessons Learned from a Randomized Controlled Trial

D. Huijgen, I. K. Schokker-van Linschoten, H. Versteegh, J. G. R. Ruseler-van Embden, L. V. van Lieshout, Jon D. Laman, C. Sloots

Children, 2025

30 participants · 1 citation

Abstract

Highlights What are the main findings? Diaper dermatitis occurs in 73.1% of children after gastrointestinal surgery. Diaper dermatitis develops within the first two weeks following surgery. What are the implications of the main findings? Diaper dermatitis is a significant clinical issue that requires increased awareness and attention in both research and practice. Although no superior preventive strategy was identified, the study offers valuable epidemiological and methodological insights to enhance future investigations. Abstract Background: Diaper dermatitis (DD) frequently occurs following pediatric gastrointestinal surgery and may lead to severe morbidity despite preventive measures. This study aims to evaluate the effectiveness of potato-derived protease enzyme inhibitor cream (PPEIC) in preventing DD after gastrointestinal surgery in children. Methods: In this double-blinded, single-center RCT, 30 patients under three years of age undergoing gastrointestinal surgery were randomized 1:1 to prevention using PPEIC or Panthenol cream (PC). The creams were applied after each diaper change for four weeks postoperatively. At two and four weeks, two observers evaluated photographs of the perianal region for the presence and severity of DD. The primary outcome was the severity of DD four weeks after surgery. Results: From November 2020 to March 2023, 30 patients were included. Two patients withdrew directly after randomization, resulting in 13 PPEIC and 15 PC patients. In…

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 30 participants or records.

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