Comparing Duramesh Device to Polydioxanone Suture for Closing Laparotomy Incisions to Reduce Surgical Complications and Incisional Hernias

What this Trial Is About

Researchers are comparing two methods for closing the abdomen after laparotomy surgery Duramesh and polydioxanone sutures PDS. The goal is to see if Duramesh is not worse than PDS for early surgical site events within one month after surgery and if it is better at preventing incisional hernias within one year. This study also looks at device performance, technical success of the surgery, pain, implant sensation, satisfaction of both patients and surgeons, and quality of life over 12 months. Participants will have their abdominal incision closed using either Duramesh, a device that combines mesh repair and suturing precision, or standard PDS sutures. Duramesh is designed to reduce surgical site events by distributing forces and allowing tissue growth into the repair. The study uses size 1 Duramesh, which is CE-marked, while the comparison group uses 2-0, 0, or number 1 PDS sutures. The study is randomized, with procedures performed during laparotomy surgery, and follow-up evaluations occur at 1 and 12 months after surgery. During the study, participants will be assessed for surgical site events, including wound problems and hernia occurrence, at various times up to 12 months. Researchers will evaluate pain using a numeric rating scale, implant sensation, and satisfaction from both patients and surgeons using 5-point scales. Quality of life will be measured with a health survey at 12 months. Safety, device performance, and any need for additional surgeries related to the device will also be monitored throughout the year-long follow-up.

Duramesh™ vs Polydioxanone Suture for Laparotomy Closure