Clinical trial NCT05804136: Duramesh™ vs Polydioxanone Suture for Laparotomy Closure
Official title: A Prospective Randomized Controlled Trial Comparing Duramesh™ With Polydioxanone Suture for Laparotomy Closure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Laparotomy Closure After Abdominal Surgery
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Investigator-initiated, academic, prospective, randomized-controlled, interventional, monocenter study
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The primary outcome is SSE that occurs within 1 month after surgery.
timeFrame: 1 month
Secondary outcomes:
measure: SSE within the first 12 months after repair.
timeFrame: 12 months
measure: Clinical hernia occurrence/recurrence within 12 months after repair.
timeFrame: 12 months
measure: Return to the operating room (re-interventions) within 12 months for device related issue.
timeFrame: 12 months
measure: Surgeon satisfaction at index-procedure using the 5-point smiley face scale.
timeFrame: Procedure
measure: Surgeon satisfaction at 1-month follow-up using the 5-point smiley face scale.
timeFrame: 1 month
measure: Technical success of index-procedure.
timeFrame: Procedure
measure: Device performance using the 5-point smiley face scale.
timeFrame: Procedure
measure: Pain of the surgical incision using 11 point Numeric Pain Rating Scale (NRS) at 1-month follow-up.
timeFrame: 1 month
measure: Pain of the surgical incision using 11 point Numeric Pain Rating Scale (NRS) at 12-months follow-up.
timeFrame: 12 months
measure: Palpability/sensation of suture used for the repair at 12-months follow-up.
timeFrame: 12 months
measure: Quality of life using Short Form 12 (SF-12) health survey at 12-months follow-up.
timeFrame: 12 months
measure: Patient satisfaction at 1-month follow-up 5-point smiley face scale.
timeFrame: 1 month
measure: Patient satisfaction at 12-months follow-up 5-point smiley face scale.
timeFrame: 12 months
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: UZ Gent
state: Oost-Vlaanderen
Study officials:
References: