Trials / Recruiting
RecruitingNCT06220045
Comparing PP and PVDF Meshes in Midline Laparotomy Closure for High-risk Colorectal Surgery. Impact on Incisional Hernia and Surgical Wound Infection.
Comparison Between the Use of a Polypropylene (PP) Prophylactic Mesh and a Polyvinylidene Fluoride (PVDF) Mesh in the Closure of Midline Laparotomy in Emergency Colorectal Surgery for High-risk Patients of Incisional Hernia. Impact on Surgical Wound Infection.
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
In the latest guidelines for abdominal wall closure in emergency surgery published in the World Journal of Emergency Surgery (WJES) in 2023, no specific recommendations are made in this regard. Current literature does not provide any articles comparing these two types of mesh materials (PP vs PVDF) in emergency colorectal surgery. It is necessary to conduct a study comparing these two types of mesh materials, specifically in high-risk patients for incisional hernia and emergency colorectal surgery. This study aims to contribute to generating evidence regarding differences in wound infection incidence and potential subsequent complications, such as chronic pain. It is essential to conduct a study comparing different methods of laparotomy closure, specifically in emergency colorectal surgery, to contribute valuable evidence regarding the incidence of incisional hernia and potential subsequent complications.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | Polyvinylidene fluoride mesh | Midline laparotomy closure using the "small bites" technique associated with a prophylactic suprafascial polyvinylidene fluoride mesh. |
| COMBINATION_PRODUCT | Prophylactic polypropylene mesh | Midline laparotomy closure using the "small bites" technique associated with a prophylactic suprafascial polypropylene mesh. |
Timeline
- Start date
- 2024-02-01
- Primary completion
- 2025-01-15
- Completion
- 2025-01-15
- First posted
- 2024-01-23
- Last updated
- 2024-10-08
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT06220045. Inclusion in this directory is not an endorsement.