A Prospective Randomized Controlled Trial Comparing Duramesh™ With Polydioxanone Suture for Laparotomy Closure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University Hospital, Ghent
- Enrollment
- 230
- Locations
- 2
- Primary Endpoint
- The primary outcome is SSE that occurs within 1 month after surgery.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
The primary outcome is SSE that occurs within 1 month after surgery.
Time Frame: 1 month
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). SSE include: Seroma, Hematoma, Soft tissue breakdown, Fascial dehiscence, Cellulitis, Suture granuloma, Chronic draining sinus, Enterocutaneous fistula, Superficial, deep and organ/space infections, Other
Secondary Outcomes
- Clinical hernia occurrence/recurrence within 12 months after repair.(12 months)
- Palpability/sensation of suture used for the repair at 12-months follow-up.(12 months)
- Technical success of index-procedure.(Procedure)
- Device performance using the 5-point smiley face scale.(Procedure)
- Surgeon satisfaction at 1-month follow-up using the 5-point smiley face scale.(1 month)
- Pain of the surgical incision using 11 point Numeric Pain Rating Scale (NRS) at 12-months follow-up.(12 months)
- SSE within the first 12 months after repair.(12 months)
- Return to the operating room (re-interventions) within 12 months for device related issue.(12 months)
- Surgeon satisfaction at index-procedure using the 5-point smiley face scale.(Procedure)
- Quality of life using Short Form 12 (SF-12) health survey at 12-months follow-up.(12 months)
- Patient satisfaction at 1-month follow-up 5-point smiley face scale.(1 month)
- Patient satisfaction at 12-months follow-up 5-point smiley face scale.(12 months)
- Pain of the surgical incision using 11 point Numeric Pain Rating Scale (NRS) at 1-month follow-up.(1 month)