Duramesh™ vs Polydioxanone Suture for Laparotomy Closure

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

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.

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.

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