Dehydrated Human Amnion-Chorion Membrane for Incisional Hernia Prophylaxis in High-Risk Laparotomy Patients: A Randomized Clinical Trial

Background Incisional hernias (IHs) represent a major, recurring burden on patients and the health care system. No standard of care for the prevention of IH has been widely adopted in the United States. This study aimed to quantify the efficacy of dehydrated human amnion-chorion membrane (dHACM) in IH prophylaxis (IHP). Methods This prospective, double-blinded, multicentered randomized controlled trial enrolled patients across five sites from June 10, 2020, to September 7, 2023. Eligibility criteria included patients over 18 years old undergoing elective laparotomy with a predicted IH risk ≥150% of average. Screening was conducted using the University of Pennsylvania Incisional Hernia Risk Calculator. Enrolled participants were randomized 1:1 to standard fascial closure with onlay dHACM or standard fascial closure alone. Follow-up was conducted 6 months post-laparotomy. Primary outcomes were IH formation rate within 6 months of laparotomy and IH size. Results A total of 530 participants were screened: 234 were enrolled and 296 were excluded. Blinded assessment of IH formation 6 months postoperatively was obtained in 128 (54.7%) enrolled participants (mean age, 55.5 years [SD, 13.5 years]). Incisional hernia occurred in 14 (12.1%) control arm participants (n = 116) and 10 (8.5%) treatment arm participants (n = 118) (22.0% relative reduction, P = .345). Median IH size between the study arms was not statistically significant (9.2 vs 7.2, P = .881). Discussion Inadequate enrollment resulted in this trial being underpowered. Although a lower IH rate was observed with prophylactic onlay dHACM, this difference was not statistically significant. These findings warrant further evaluation in adequately powered studies.