An interventional study of prophylactic polypropilene mesh and Midline Fascial Closure in Surgical Wound Dehiscence, sponsored by University of Sao Paulo General Hospital. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-17.
Sponsored by University of Sao Paulo General Hospital · Not applicable, Interventional, and Prevention
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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.
48 studies on the registry are indexed under Surgical Wound Dehiscence; 14 are open to participants now.
This study's enrollment of 145 is above the median of 78 across 37 interventional studies indexed under Surgical Wound Dehiscence.
Browse Surgical Wound Dehiscence studies →University of Sao Paulo General Hospital is the lead sponsor of 611 studies on the registry; 98 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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High risk for abdominal wound dehiscence: Risk index** ≥ 4,0 or ≥ 2,2 in combination with at least one of the following: smoking, obesity, malnutrition or malignant neoplasia.
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:
Patients randomized to this arm will undergo midline laparotomy closure using a PDS 0 continuous suture only, without mesh, aiming a suture length to wound length ratio higher than four. Randomization occurs after fascial closure.
Procedure: Midline Fascial Closure
Patients randomized to this arm will undergo midline laparotomy closure using a PDS 0 continuous suture aiming a suture length to wound length ratio higher than four AND further polypropilene onlay mesh. Randomization occurs after fascial closure.
Device: prophylactic polypropilene mesh · Procedure: Midline Fascial Closure · Device: vacuum drainage system
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
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
Plan to share: No
Ran from Jun 2015 to primary completion in Mar 2017, 21 months.
Of 15 interventional studies with no phase under Surgical Wound Dehiscence, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 32. This study's 21 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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