NCT03293862

Prevention of Fascial Dehiscence With Prophylactic Onlay Mesh in Emergency Laparotomies

Prevention of Fascial Dehiscence With Prophylactic Onlay Mesh in Emergency Laparotomies: a Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Facial dehiscence elicit high morbidity and mortality. This complication may arise in more than 8.5% of high-risk patients. Addressing risk factors and optimizing surgical technique are guarded as mainstay measures for prevention, but their efficacy is questionable. The aim of this study is to analyze the influence of using a polypropylene onlay prophylactic mesh on the incidence of fascial dehiscence in emergency surgery and associated complications.

Detailed description

Fascial dehiscence is associated with high morbidity and mortality rates. It occurs in more than 8.5% of high-risk patients. Current preventive measures described are control of risk factors and optimization of surgical technique. Despite that, the incidence of such complication remained stable in the last decades, highlighting the low efficacy of such measures. Polypropilene onlay mesh has been used to avoid incisional hernias in selected elective patients, and could be useful in the prevention of fascial dehiscence. In emergency situations, especially in contaminated and infected surgical procedures, safety and efficacy of mesh is controversial. In this study the investigators aimed to evaluate the influence of polypropilene prophylactic onlay mesh on the incidence of fascial dehiscence in high-risk patients undergoing midline emergency laparotomy. As secondary outcome, the associated morbidity, including surgical site occurence, will be analyzed. The study design will be a randomized controlled trial.

Conditions

• Surgical Wound Dehiscence

Interventions

Type	Name	Description
DEVICE	prophylactic polypropilene mesh	Placement of onlay polypropilene prophylactic mesh after midline fascial closure.
PROCEDURE	Midline Fascial Closure	midline fascial closure using uninterrupted PDS 0 suture
DEVICE	vacuum drainage system	Placement of a subcutaneous vacuum drainage system

Timeline

• Start date: 2015-06-01
• Primary completion: 2017-03-01
• Completion: 2018-02-01
• First posted: 2017-09-26
• Last updated: 2019-04-17

Locations

1 site across 1 country: Brazil