Durameshâ„¢ vs Polydioxanone Suture for Laparotomy Closure (NCT05804136) | Clinical Trial Compass
RecruitingNot Applicable
Durameshâ„¢ vs Polydioxanone Suture for Laparotomy Closure
Belgium230 participantsStarted 2023-03-31
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
The primary outcome is SSE that occurs within 1 month after surgery.