title: 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.
abstract: 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.
  
  
  
  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.
  
  
  
  Patients 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.
  
  
  
  Patients 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).
  
  
  
  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.
authors.affiliation: *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.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Rosen
authors.forename: Joel J
authors.initials: JJ
authors.lastname: Bauer
authors.forename: Marco
authors.initials: M
authors.lastname: Harmaty
authors.forename: Alfredo M
authors.initials: AM
authors.lastname: Carbonell
authors.forename: William S
authors.initials: WS
authors.lastname: Cobb
authors.forename: Brent
authors.initials: B
authors.lastname: Matthews
authors.forename: Matthew I
authors.initials: MI
authors.lastname: Goldblatt
authors.forename: Don J
authors.initials: DJ
authors.lastname: Selzer
authors.forename: Benjamin K
authors.initials: BK
authors.lastname: Poulose
authors.forename: Bibi M E
authors.initials: BM
authors.lastname: Hansson
authors.forename: Camiel
authors.initials: C
authors.lastname: Rosman
authors.forename: James J
authors.initials: JJ
authors.lastname: Chao
authors.forename: Garth R
authors.initials: GR
authors.lastname: Jacobsen
mesh_terms: D020341:Absorbable Implants; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006305:Health Status Indicators; D006555:Hernia, Ventral / Q000601:surgery*; D059685:Herniorrhaphy / Q000295:instrumentation* / Q000379:methods; D006801:Humans; D053208:Kaplan-Meier Estimate; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D012008:Recurrence; D013526:Surgical Mesh; D013530:Surgical Wound Infection / Q000453:epidemiology / Q000209:etiology*; D016896:Treatment Outcome