Duramesh™ vs Polydioxanone Suture for Laparotomy Closure

NCT ID: NCT05804136

Last Updated: 2025-04-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-31
• Study Completion Date: 2027-07-31

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.

Detailed Description

This clinical investigation is designed to compare laparotomy closure with Duramesh to closure using PDS. The primary outcome is SSE that occurs within 1 month after surgery. Secondary outcomes that will be studied include device performance and technical success of the index-procedure, hernia occurrence/recurrence noted at 12 months after surgery, SSE and re-interventions that occur within 12 months of surgery, pain, implant palpability/sensation, surgeon and patient satisfaction, and quality of life.

Conditions

Laparotomy Closure After Abdominal Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Duramesh

Laparotomy closure is associated with the occurrence of Surgical Site Events (SSEs) such as wound dehiscence and incisional hernias. Abdominal wall closure can also cause pain and discomfort, or can lead to intestinal obstruction.

Standard sutures can cut through otherwise intact tissue due to the presence of a sharp leading edge leading to repair failure. Meshes distribute forces and allow for tissue ingrowth. Duramesh combines the desirable principles of a mesh repair with the placement precision of a suture. It is the world's first device that both approximates tissue and allows ingrowth for a strong early repair.

Consequently, the expected clinical benefit is the reduced occurrence of Surgical Site Events such as incisional hernias. Additional benefits may include reduced pain and improved quality of life due to durable closure of the abdominal wall with Duramesh. This will be evaluated in this randomized study.

Size 1 Duramesh is used in this RCT. Duramesh is CE-marked.

Group Type: OTHER

Duramesh

Intervention Type: DEVICE

Laparotomy closure with Duramesh

Standard suture

2-0, 0, or Number 1 polydioxanone suture (PDS) is used as comparator.

Group Type: OTHER

Polydioxanone suture

Intervention Type: DEVICE

Laparotomy closure with standard PDS

Interventions

Duramesh

Laparotomy closure with Duramesh

Intervention Type: DEVICE

Polydioxanone suture

Laparotomy closure with standard PDS

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UZ Gent

Ghent, Oost-Vlaanderen, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Dorien Haesen, PhD

Role: CONTACT

dorien.haesen@archerresearch.eu

+32 11 28 69 48

Facility Contacts

Frederik Berrevoet, Prof. Dr.

Role: primary

Other Identifiers

MOMENTUM RCT ONZ-2022-0507

Identifier Type: -

Identifier Source: org_study_id