DuraMesh Laparotomy Closure Following Trauma and Emergency Surgery

This is a multisite randomized control proof-of-concept trial to evaluate the safety of DuraMesh™ laparotomy closure in the trauma and emergency laparotomy setting. Approximately 120 patients will be randomized (2:1) to DuraMesh™ laparotomy closure versus conventional suture closure. #1 DuraMesh™ will be provided for patients assigned to the DuraMesh™ treatment arm. Patients will participate in a one-year follow-up regime (2 weeks,1 month, 3 months, 6 months and 12 months). Primary Laparotomy Closure Treatment 1) Study Group - DuraMesh™ Laparotomy Closure (DLC) Treatment 2) Control Group - Conventional Suture Closure (CSC) Patients undergoing a midline laparotomy for trauma or emergency surgery will be randomized to either #1 DuraMesh™ suture or conventional laparotomy closure using size #1 slowly-absorbing (PDS) single strand or looped suture, based on surgeon preference. All patients will be assessed for post-operative complications at 2 weeks, 1 month, 3 months, 6 months, and 12 months postoperatively. Patients will also be assessed for incisional hernia formation at the same post-operative time points (2 weeks,1 month, 3 months, 6 months, 12 months). Hernia outcomes will be based on physical examination, with ultrasound used for any uncertainties.