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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
145
Placement of onlay polypropilene prophylactic mesh after midline fascial closure.
midline fascial closure using uninterrupted PDS 0 suture
Placement of a subcutaneous vacuum drainage system
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São, Brazil
Fascial dehiscence incidence
Time frame: 30 days
Surgical site occurence (SSO) incidence
Time frame: 30 days or during hospital stay
Surgical site occurrence requiring procedural intervention (SSOPI) incidence
Time frame: 30 days or during hospital stay
Operative time (minutes),
Time frame: 30 days
Hospital length of stay (days)
Time frame: 30 days
Intensive care unit length of stay (days)
Time frame: 30 days
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