Actively Recruiting
Duramesh™ vs Polydioxanone Suture for Laparotomy Closure
Led by University Hospital, Ghent · Updated on 2025-04-17
230
Participants Needed
1
Research Sites
226 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Duramesh™ vs Polydioxanone Suture for Laparotomy Closure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
UZ Gent
Ghent, Oost-Vlaanderen, Belgium, 9000
Actively Recruiting
Research Team
D
Dorien Haesen, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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