Infectious Complication in Relation to the Prophylactic Mesh Position: The PRIMA Trial Revisited

Abstract

Background: Prophylactic mesh reinforcement has proven to reduce the incidence of incisional hernia (IH). Fear of infectious complications may withhold the widespread implementation of prophylactic mesh reinforcement, particularly in the onlay position.

Study design: Patients scheduled for elective midline surgery were randomly assigned to a suture closure group, onlay mesh group, or sublay mesh group. The incidence, treatment, and outcomes of patients with infectious complications were assessed through examining the adverse event forms. Data were collected prospectively for 2 years after the index procedure.

Results: Overall, infectious complications occurred in 14/107 (13.3%) patients in the suture group and in 52/373 (13.9%) patients with prophylactic mesh reinforcement (p = 0.821). Infectious complications occurred in 17.6% of the onlay group and 10.3% of the sublay group (p = 0.042). Excluding anastomotic leakage as a cause, these incidences were 16% (onlay) and 9.7% (sublay), p = 0.073. The mesh could remain in-situ in 40/52 (77%) patients with an infectious complication. The 2-year IH incidence after onlay mesh reinforcement was 10 in 33 (30.3%) with infectious complications and 15 in 140 (9.7%) without infectious complications (p = 0.003). This difference was not statistically significant for the sublay group.

Conclusions: Prophylactic mesh placement was not associated with increased incidence, severity, or need for invasive treatment of infectious complications compared with suture closure. Patients with onlay mesh reinforcement and an infectious complication had a significantly higher risk of developing an incisional hernia, compared with those in the sublay group.