Duramesh™ vs Polydioxanone Suture for Laparotomy Closure

Last updated: April 14, 2025
Sponsor: University Hospital, Ghent
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Polydioxanone suture

Duramesh

Clinical Study ID

NCT05804136
MOMENTUM RCT ONZ-2022-0507
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

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 theindex-procedure

Exclusion

Exclusion Criteria:

  • Pregnancy

  • Presence of clinically recognized hernia at laparotomy site (parastomal hernia notedat time of ostomy site takedown is not an exclusion criterion. Subclinicalincidental small hernia < 1 cm in greatest dimension found at the time of alaparotomy 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 wallor 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

Study Design

Total Participants: 230
Treatment Group(s): 2
Primary Treatment: Polydioxanone suture
Phase:
Study Start date:
March 31, 2023
Estimated Completion Date:
July 31, 2027

Study 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.

Connect with a study center

  • UZ Gent

    Gent, Oost-Vlaanderen 9000
    Belgium

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.