Duramesh™ vs Polydioxanone Suture for Laparotomy Closure

Recruiting now · Not applicable

Conditions studied: Laparotomy Closure After Abdominal Surgery

In brief

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.

Key facts

Study ID

NCT05804136

Run by

University Hospital, Ghent

People needed

230

Starts

2023-03-31

Expected to finish

2027-07-31

Last updated by the study team

2025-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 or greater
• Abdominal laparotomy 5 cm in length or greater, either midline or non-midline
• Isolated ostomy site takedown with or without parastomal hernia
• Patient accepts participation and gives informed consent
• Patient and investigator signed and dated the informed consent form prior to the index-procedure

You may not qualify if…

• Pregnancy
• Presence of clinically recognized hernia at laparotomy site (parastomal hernia noted at time of ostomy site takedown is not an exclusion criterion. Subclinical incidental small hernia < 1 cm in greatest dimension found at the time of a laparotomy is not an automatic exclusion criterion)
• Prior hernia repair at laparotomy site
• Use of planar mesh in addition to sutures for closure
• CDC IV dirty or infected wound that causes the surgeon to leave the abdominal wall or skin incision open
• Life expectancy less than 1 year
• Patient is unable / unwilling to provide informed consent
• Patient is unable to comply with the protocol or proposed follow-up visits
• Patient is enrolled in another abdominal wall study

Where it is running

• UZ Gent — Ghent, Oost-Vlaanderen, Belgium (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.