Using a biosynthetic mesh to prevent incisional hernias after abdominal surgery
Safety and Efficacy of Prophylactic Resorbable Biosynthetic Mesh Following Midline Laparotomy in Clean/Contaminated Field: Protocol for a Multicenter Randomized Double Blind Prospected Trial.
This study is testing a new type of mesh to see if it can help prevent hernias after abdominal surgery compared to regular stitching.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 151 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Sanitaria Locale Napoli 2 Nord Academic / other |
| Locations | 1 site (Naples) |
| Trial ID | NCT04471311 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and effectiveness of a prophylactic biosynthetic mesh (BIO-A) in preventing incisional hernias following midline laparotomy in patients with clean-contaminated and contaminated wounds. It is designed as a double-blind randomized controlled trial comparing traditional running suture closure to closure reinforced with the biosynthetic mesh. The study will analyze the incidence of incisional hernias and assess the feasibility of using this mesh in surgical procedures. The findings could provide insights into reducing postoperative complications associated with abdominal surgeries.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years undergoing midline laparotomy with clean-contaminated or contaminated wounds.
Not a fit: Patients with clean or dirty wounds, those under 18 years, or those with a life expectancy of less than 24 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of incisional hernias, improving patient outcomes and quality of life.
How similar studies have performed: Previous studies have shown positive outcomes with prophylactic mesh placement in preventing incisional hernias, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age \> 18 years * Clean-contaminated, contaminated wounds • midline laparotomy \>10 cm * Informed consent Exclusion Criteria: * age \< 18 years; * life expectancy \< 24 months (as estimated by the operating surgeon), - • pregnancy * immunosuppressant therapy within 2 weeks before surgery * clean and dirty wounds * wound length\<10 cm.
Where this trial is running
Naples
- francesco Pizza — Naples, Italy (Recruiting)
Study contacts
- Study coordinator: Francesco Pizza
- Email: francesco_pizza@libero.it
- Phone: 3338275449
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.