Status:
UNKNOWN
Safety and Efficacy of Prophylactic Re-sorbable Biosynthetic Mesh Following Midline Laparotomy in Clean/Contaminated Field.
Lead Sponsor:
Azienda Sanitaria Locale Napoli 2 Nord
Conditions:
Incisional Hernia After Midline Laparotomy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of the present study is to analyse the feasibility, safety and IH rate using a prophylactic sublay biosynthetic BIO-A (GORE) mesh in order to prevent incisional hernia following midline laparo...
Detailed Description
Incisional Hernia (IH) is one of the most frequent postoperative complications in abdominal surgery causing significant morbidity and even mortality. The risk of developing an IH following primary ele...
Eligibility Criteria
Inclusion
- age \> 18 years
- Clean-contaminated, contaminated wounds • midline laparotomy \>10 cm
- Informed consent
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2024
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT04471311
Start Date
January 1 2024
End Date
June 30 2024
Last Update
October 30 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
francesco Pizza
Naples, Italy