OC-019 MESH-RTL PROJECT FOR PREVENTION OF WOUND ABDOMINAL DEHISCENCE: NON-INFERIORITY CLINICAL TRIAL TO COMPARE TWO APONEUROTIC CLOSURE TECHNIQUES IN MIDLINE LAPAROTOMY IN PATIENTS WITH ELEVATED RISK

Abstract

Abstract Aim Abdominal wound dehiscence (AWD) has an incidence of 2–4%, which can increase to 20% in specific risk groups. The aim of this study is to report the results of the use of the reinforced tension line (RTL) technique compared with the use of onlay mesh closure (OM) in the prevention of AWD in high-risk patients undergoing laparotomy. Material and Methods Non-inferiority open randomized controlled clinical trial. Included were patients older than 18 years who underwent midline laparotomy, emergency or scheduled, who were considered high risk. The patients were randomized 1:1 to the RTL technique or to OM. The objective was to report the incidence of AWD and the complications associated with the closure method. Intention-to-treat analyses were performed. Results A total of 239 patients were randomized; 118 patients from the RTL group and 121 patients from the OM group. The global incidence of AWD was 8.8% (21 patients). We did not find a statistically significant difference between the two groups, RTL group (13/118, 11%) and OM group (8/121, 6.6%) (p=0.259, OR 0.6, 95% CI 0.25–1.39). The groups were similar in the rates of surgical site infection, hematoma, seroma, and postoperative pain during follow-up. Conclusions The RTL and OM techniques are useful in the prevention of AWD in high-risk midline laparotomy patients, the advantage of RTL is that it can be used in patients with a contaminated, or dirty abdomen and its cost does not go beyond a couple of sutures.