NCT05804136

Duramesh™ vs Polydioxanone Suture for Laparotomy Closure

A Prospective Randomized Controlled Trial Comparing Duramesh™ With Polydioxanone Suture for Laparotomy Closure

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 230 (estimated)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is intended to demonstrate the non-inferiority of a Duramesh closure as compared to a polydioxanone closure for early surgical site events (SSE) (\< 1 month), and Duramesh superiority to polydioxanone for the development of incisional hernia by 1 year for a laparotomy closure.

Detailed description

This clinical investigation is designed to compare laparotomy closure with Duramesh to closure using PDS. The primary outcome is SSE that occurs within 1 month after surgery. Secondary outcomes that will be studied include device performance and technical success of the index-procedure, hernia occurrence/recurrence noted at 12 months after surgery, SSE and re-interventions that occur within 12 months of surgery, pain, implant palpability/sensation, surgeon and patient satisfaction, and quality of life.

Conditions

• Laparotomy Closure After Abdominal Surgery

Interventions

Type	Name	Description
DEVICE	Duramesh	Laparotomy closure with Duramesh
DEVICE	Polydioxanone suture	Laparotomy closure with standard PDS

Timeline

• Start date: 2023-03-31
• Primary completion: 2026-06-30
• Completion: 2027-07-31
• First posted: 2023-04-07
• Last updated: 2025-04-17

Locations

1 site across 1 country: Belgium