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RecruitingNot ApplicableNCT05804136

Duramesh™ vs Polydioxanone Suture for Laparotomy Closure

A Prospective Randomized Controlled Trial Comparing Duramesh™ With Polydioxanone Suture for Laparotomy Closure

Sponsor

University Hospital, Ghent

Enrollment

230 participants

Start Date

Mar 31, 2023

Study Type

INTERVENTIONAL

Conditions

Laparotomy Closure After Abdominal Surgery

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria9

  • 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

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Interventions

DEVICEDuramesh

Laparotomy closure with Duramesh

DEVICEPolydioxanone suture

Laparotomy closure with standard PDS

Locations(1)

UZ Gent

Ghent, Oost-Vlaanderen, Belgium

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NCT05804136