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

<b>Background</b>: 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. <b>Methods</b>: 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. <b>Results</b>: 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 total, nineteen patients (73.1%) developed DD-eight (66.7%) in the PPEIC group and 11 (78.6%) in the PC group (<i>p</i> = 0.665)-of whom twelve (63.2%) suffered severe DD. All DD cases developed within the first two weeks, resulting in half of the patients discontinuing the preventive cream before the four-week endpoint. <b>Conclusions</b>: This study highlights the significant issue of DD after gastrointestinal surgery, which affects 73.1% of diapered children despite prevention with PPEIC or PC. Although the study was unable to identify a superior preventive method, it offers valuable insights and goals for future research.