Mesh Vs RTL project

Purpose: To compare reinforced tension line (RTL) and mesh techniques in the onlay position for abdominal wound dehiscence (AWD) prevention in a noninferiority clinical trial.
Methods: Patients >18 years old who underwent midline laparotomy regardless of the background diagnosis, who were urgent or scheduled, or who were considered high risk according to a score equal to or greater than 4 on the modified Rotterdam risk scale were included. The primary outcome was the incidence of AWD within the first 30 days post-surgery, and the secondary outcome was the incidence of complications reported as surgical site occurrence (SSO).
Results: In total, 239 patients were included: 121 in the mesh group and 118 in the RTL group. Five (4.1%) of the 121 patients in the mesh group and 7 (5.9%) of the 118 patients in the RTL group presented with AWD (p= 0.56, RR=0.69, 95% CI=0.22-2.13) in the per-protocol analysis. The median time of presentation was 6 days, and all AWD patients were clinically diagnosed. The 95% CI (-0.0567, 0.0231) for the difference in incidence between the two groups was entirely within the predefined noninferiority margin of 5%. The incidence of complications was greater, but not significantly so, in the mesh group (27, 22.3%) than in the RTL group (16, 12.8%).
Conclusions: Use of the RTL technique for preventing AWD injury is not inferior to the use of mesh in the onlay position, nor does it increase the risk of complications. This study was registered on clinicaltrials.gov: Mesh-RTL Project (NCT04134455).