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Multicenter Study Observational Study
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.
- Michael J Rosen, Joel J Bauer, Marco Harmaty, Alfredo M Carbonell, William S Cobb, Brent Matthews, Matthew I Goldblatt, Don J Selzer, Benjamin K Poulose, Bibi M E Hansson, Camiel Rosman, James J Chao, and Garth R Jacobsen.
- *Department of General Surgery, Cleveland Clinic Foundation, Cleveland, OH †Department of Surgery, Mount Sinai School of Medicine, New York, NY ‡Division of Minimal Access and Bariatric Surgery, Greenville Health System, Greenville, SC §Department of Surgery, Carolinas Medical Center, Charlotte, NC ¶Department of Surgery, Medical College of Wisconsin, Milwaukee, WI ||Department of Surgery, Indiana University School of Medicine, Indianapolis, IN **Division of General Surgery, Vanderbilt University Medical Center, Nashville, TN ††Department of Surgery, Canisius-Wilhelmina Ziekenhuis, Nijmegen, The Netherlands ‡‡Oasis MD Lifestyle Healthcare, San Diego, CA §§Department of Surgery, University California, San Diego School of Medicine, San Diego, CA.
- Ann. Surg. 2017 Jan 1; 265 (1): 205-211.
ObjectiveThe 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.BackgroundCVH has an increased risk of postoperative infection. CVH repair with synthetic or biologic meshes has reported chronic biomaterial infections and high hernia recurrence rates.MethodsPatients with a contaminated or clean-contaminated operative field and a hernia defect at least 9 cm 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-to-treat population, and health outcome measures evaluated using paired t tests.ResultsPatients had a mean age of 58 years, body mass index of 28 kg/m, 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).ConclusionsIn 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.
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