The MESH-RTL Project for prevention of abdominal wound dehiscence (AWD) in high-risk patients: noninferiority, randomized controlled trial.

PURPOSE

To compare reinforced tension line (RTL) and mesh techniques in the onlay position for preventing abdominal wound dehiscence (AWD) in a noninferiority clinical trial.

METHODS

Patients > 18 years old who underwent midline laparotomy and who were considered at high risk on the modified Rotterdam risk scale were included. The outcomes analyzed were the incidence of AWD and surgical site occurrence (SSO).

RESULTS

239 patients were included: 121 mesh group and 118 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. 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 did not significantly differ between the two groups: the mesh group (27, 22.3%) and the RTL group (16, 12.8%) (p = 0.09, RR (95% CI) = 1.64 (0.93-2.89)).

CONCLUSION

The use of the RTL technique for preventing AWD was not inferior to the use of mesh in the onlay position, nor did it increase the risk of complications. This study was registered on clinicaltrials.gov: Mesh-RTL Project (NCT04134455).