NCT05804136 Duramesh™ vs Polydioxanone Suture for Laparotomy Closure
| NCT ID | NCT05804136 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Ghent |
| Condition | Laparotomy Closure After Abdominal Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 230 participants |
| Start Date | 2023-03-31 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 230 participants in total. It began in 2023-03-31 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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 informed consent form prior to the index-procedure Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05804136 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Laparotomy Closure After Abdominal Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05804136 currently recruiting?
Yes, NCT05804136 is actively recruiting participants. Contact the research team at dorien.haesen@archerresearch.eu for enrollment information.
Where is the NCT05804136 trial being conducted?
This trial is being conducted at Ghent, Belgium.
Who is sponsoring the NCT05804136 clinical trial?
NCT05804136 is sponsored by University Hospital, Ghent. The trial plans to enroll 230 participants.