Comparing Duramesh and Polydioxanone for Closing Abdominal Surgery Incisions
A Prospective Randomized Controlled Trial Comparing Duramesh™ With Polydioxanone Suture for Laparotomy Closure
NA · University Hospital, Ghent · NCT05804136
This study is testing whether using Duramesh or polydioxanone stitches for closing abdominal surgery cuts leads to fewer problems and better recovery for patients.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 230 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Ghent (other) |
| Locations | 1 site (Ghent, Oost-Vlaanderen) |
| Trial ID | NCT05804136 on ClinicalTrials.gov |
What this trial studies
This clinical investigation aims to compare the effectiveness of Duramesh closure versus polydioxanone suture for laparotomy closure after abdominal surgery. The primary focus is to assess early surgical site events within one month post-surgery, while secondary outcomes include the incidence of incisional hernias after one year, pain levels, and overall patient satisfaction. Participants will undergo a laparotomy of at least 5 cm, and their outcomes will be monitored for a year to evaluate the performance of each closure method.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older who require a laparotomy of 5 cm or greater.
Not a fit: Patients with existing hernias at the laparotomy site or those with a life expectancy of less than one year may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced hernia rates for patients undergoing abdominal surgery.
How similar studies have performed: Previous studies have shown promising results with similar closure techniques, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ghent, Oost-Vlaanderen
- UZ Gent — Ghent, Oost-Vlaanderen, Belgium (RECRUITING)
Study contacts
- Study coordinator: Dorien Haesen, PhD
- Email: dorien.haesen@archerresearch.eu
- Phone: +32 11 28 69 48
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Laparotomy Closure After Abdominal Surgery