Surgical Wound Dehiscence
Conditions
Keywords
laparotomy, emergency surgery, abdominal wound dehiscence, prophylactic mesh
Brief 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.
Interventions
DEVICEprophylactic polypropilene mesh
Placement of onlay polypropilene prophylactic mesh after midline fascial closure.
PROCEDUREMidline Fascial Closure
midline fascial closure using uninterrupted PDS 0 suture
DEVICEvacuum drainage system
Placement of a subcutaneous vacuum drainage system
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)
Intervention model description
Suture group and prophylactic mesh group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Emergency laparotomy by midline incision * 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. * Risk index is the sum of values associated with high-risk characteristics, based in the risk score for abdominal wall dehiscence published by van Ramshorst et. al. in World Journal of Surgery, 2010 (Rotterdam risk model): Age category (in years) * 40-49: 0.4 * 50-59: 0.9 * 60-69: 0.9 * ≥70: 1.1 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: * Gallbladder/bile duct 0.7 * Esophagus 1.5 * Gastroduodenum 1.4 * Small bowel 0.9 * Large bowel 1.4 * Vascular 1.3
Exclusion criteria
* Non-midline incisions or midline laparotomy measuring less than 1/4 the distance between the xyphoid and the pubis, including laparoscopic surgery. * Diagnosis of incisional hernia or presence of previous mesh on site. * Midline laparotomy performed in less than 30 days. * Pregnancy * Severe trauma with hemodynamic instability * Need for open abdomen or relaxing incisions * Need for re-laparotomy during the first 30 postoperative days, except cases in which an abdominal wall dehiscence was diagnosed. * Death during the first 30 postoperative days, except cases in which an abdominal wall dehiscence was diagnosed before the event.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fascial dehiscence incidence | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| Surgical site occurence (SSO) incidence | 30 days or during hospital stay |
| Surgical site occurrence requiring procedural intervention (SSOPI) incidence | 30 days or during hospital stay |
| Operative time (minutes), | 30 days |
| Hospital length of stay (days) | 30 days |
| Intensive care unit length of stay (days) | 30 days |
Countries
Brazil
Outcome results
None listed