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RECRUITING
NCT05804136
NA

Duramesh™ vs Polydioxanone Suture for Laparotomy Closure

Sponsor: University Hospital, Ghent

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

230

Start Date

2023-03-31

Completion Date

2027-07-31

Last Updated

2025-04-17

Healthy Volunteers

No

Interventions

DEVICE

Duramesh

Laparotomy closure with Duramesh

DEVICE

Polydioxanone suture

Laparotomy closure with standard PDS

Locations (1)

UZ Gent

Ghent, Oost-Vlaanderen, Belgium