Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São, 05403000, Brazil
NCT Number: NCT03293862
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
São Paulo, São, 05403000, Brazil
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Age category (in years)
Male gender: 0.7
Chronic pulmonary disease: 0.7
Ascites: 1.5
Jaundice: 0.5
Anemia: 0.7
Emergency surgery: 0.6
Type of surgery:
Exclusion criteria
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
Time frame: 30 days
Time frame: 30 days or during hospital stay
Time frame: 30 days or during hospital stay
Time frame: 30 days
Time frame: 30 days
Time frame: 30 days
University of Sao Paulo General Hospital
Other
Prevention of Fascial Dehiscence With Prophylactic Onlay Mesh in Emergency Laparotomies: a Randomized Clinical Trial
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