A Prospective Randomized Controlled Trial Comparing Duramesh™ With Polydioxanone Suture for Laparotomy Closure
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Belgium
UZ Gent
RECRUITING
Ghent
Contact Information
Primary
Dorien Haesen, PhD
dorien.haesen@archerresearch.eu
+32 11 28 69 48
Time Frame
Start Date: 2023-03-31
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 230
Treatments
Other: 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.
Other: Standard suture
2-0, 0, or Number 1 polydioxanone suture (PDS) is used as comparator.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Ghent