Multicenter, prospective, longitudinal study of the recurrence, surgical site infection, and quality of life after contaminated ventral hernia repair using biosynthetic absorbable mesh: The COBRA study

Objective: The aim of the study was to evaluate biosynthetic absorbable mesh in single-staged contaminated (Centers for Disease Control class II and III) ventral hernia (CVH) repair over 24 months. Background: CVH has an increased risk of postoperative infection. CVH repair with synthetic or biologic meshes has reported chronic biomaterial infections and high hernia recurrence rates. Methods: Patients with a contaminated or clean-contaminated operative field and a hernia defect at least 9 cm² had a biosynthetic mesh (open, sublay, retrorectus, or intraperitoneal) repair with fascial closure (n=104). Endpoints included overall Kaplan-Meier estimates for hernia recurrence and postoperative wound infection rates at 24 months, and the EQ-5D and Short Form 12 Health Survey (SF-12). Analyses were conducted on the intent-totreat population, and health outcome measures evaluated using paired t tests. Results: Patients had a mean age of 58 years, body mass index of 28 kg/m2, 77% had contaminated wounds, and 84% completed 24-months follow-up. Concomitant procedures included fistula takedown (n=24) or removal of infected previously placed mesh (n=29). Hernia recurrence rate was 17% (n=16). At the time of CVH repair, intraperitoneal placement of the biosynthetic mesh significantly increased the risk of recurrences (P≤0.04). Surgical site infections (19/104) led to higher risk of recurrence (P<0.01). Mean 24-month EQ-5D (index and visual analogue) and SF-12 physical component and mental scores improved from baseline (P<0.05). Conclusions: In this prospective longitudinal study, biosynthetic absorbable mesh showed efficacy in terms of long-term recurrence and quality of life for CVH repair patients and offers an alternative to biologic and permanent synthetic meshes in these complex situations.