Duramesh™ vs Polydioxanone Suture for Laparotomy Closure
Recruiting
N/A
Interventional Study
Laparotomy Closure After Abdominal Surgery
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 230 (estimated)
- Sponsor
- University Hospital, Ghent · Other
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About This Trial
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 inform…
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