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Duramesh™ vs Polydioxanone Suture for Laparotomy Closure

NCT05804136 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2025-04-17

No results posted yet for this study

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.

Conditions

  • Laparotomy Closure After Abdominal Surgery

Interventions

DEVICE

Duramesh

Laparotomy closure with Duramesh

DEVICE

Polydioxanone suture

Laparotomy closure with standard PDS

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-31
Primary Completion
2026-06-30
Completion
2027-07-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05804136 on ClinicalTrials.gov