Duramesh™ vs Polydioxanone Suture for Laparotomy Closure

NCT05804136 | Recruiting DMC

• 1 other identifier: MOMENTUM RCT ONZ-2022-0507
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparotomy Closure After Abdominal Surgery

Outcome Measures

Primary Outcomes (1)

• The primary outcome is SSE that occurs within 1 month after surgery.

  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). SSE include: Seroma, Hematoma, Soft tissue breakdown, Fascial dehiscence, Cellulitis, Suture granuloma, Chronic draining sinus, Enterocutaneous fistula, Superficial, deep and organ/space infections, Other

  1 month

Secondary Outcomes (13)

• SSE within the first 12 months after repair.

  12 months

• Clinical hernia occurrence/recurrence within 12 months after repair.

  12 months

• Return to the operating room (re-interventions) within 12 months for device related issue.

  12 months

• Surgeon satisfaction at index-procedure using the 5-point smiley face scale.

  Procedure

• Surgeon satisfaction at 1-month follow-up using the 5-point smiley face scale.

  1 month

Study Arms (2)

Duramesh

OTHER

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.

Device: Duramesh

Standard suture

OTHER

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

Device: Polydioxanone suture

Interventions

Duramesh DEVICE

Laparotomy closure with Duramesh

Duramesh

Polydioxanone suture DEVICE

Laparotomy closure with standard PDS

Standard suture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

UZ Gent

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

Central Study Contacts

Dorien Haesen, PhD

CONTACT

+32 11 28 69 48; dorien.haesen@archerresearch.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Investigator-initiated, academic, prospective, randomized-controlled, interventional, monocenter study

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 7, 2023
• Study Start: March 31, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)