title: Outcomes of a prospective multi-center trial of a second-generation composite mesh for open ventral hernia repair.
abstract: OBJECTIVE
  Composite mesh prostheses incorporate properties of multiple materials for use in open ventral hernia repair (OVHR). This study examines clinical outcomes in patients who underwent OVHR with a polypropylene/expanded polytetrafluoroethylene (ePTFE) composite graft containing a novel polydioxanone (PDO) absorbable ring to facilitate placement and graft positioning.
  
  
  METHODS
  Data were prospectively collected on consecutive patients undergoing OVHR using a synthetic composite mesh. Seven centers enrolled patients during the study period. All patients underwent a standardized surgical procedure consisting of OVHR with sublay intraperitoneal placement of mesh. Mesh fixation was accomplished with peripheral tacks and transfascial sutures.
  
  
  RESULTS
  One hundred and nineteen patients underwent OVHR with the composite mesh. Average age was 55.8 years; there were 71 (59.7 %) females and 48 (40.3 %) males with mean BMI of 33.5 ± 7.1 kg/m(2). One hundred and two (85.7 %) patients presented with primary ventral hernias. Mean defect size was 13.6 cm(2), and mean mesh size was 113.6 cm(2). Most patients (67 %) were discharged the day of surgery. Twelve patients (10.1 %) experienced complications in the perioperative time period primarily consisting of seroma (4.2 %) and ileus (1.7 %). Two patients required reoperation and mesh removal in the early postoperative period for infection and herniorrhaphy site pain, respectively. There was a decline in pain and movement limitation scores between baseline and 1-year follow-up. Six-month (n = 109) and twelve-month (n = 99) follow-up revealed no hernia recurrences (95 % CI 0-3 %, and 0-4 %, respectively).
  
  
  CONCLUSIONS
  The use of this second-generation composite mesh was associated with no hernia recurrences and a low complication rate after open ventral hernia repair.
authors.affiliation: Department of General Surgery, Division of Hepato-Pancreato-Biliary Surgery, Carolinas Medical Center, 1025 Moorehead Medical Drive, Suite 300, Charlotte, NC, 28204, USA.
authors.forename: E M
authors.initials: EM
authors.lastname: Hanna
authors.forename: J F
authors.initials: JF
authors.lastname: Byrd
authors.forename: M
authors.initials: M
authors.lastname: Moskowitz
authors.forename: J W F
authors.initials: JW
authors.lastname: Mann
authors.forename: K T
authors.initials: KT
authors.lastname: Stockamp
authors.forename: G N
authors.initials: GN
authors.lastname: Patel
authors.forename: M A
authors.initials: MA
authors.lastname: Beneke
authors.forename: K
authors.initials: K
authors.lastname: Millikan
authors.forename: D A
authors.initials: DA
authors.lastname: Iannitti
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D020878:Device Removal; D005260:Female; D006555:Hernia, Ventral / Q000601:surgery*; D059685:Herniorrhaphy / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D006801:Humans; D045823:Ileus / Q000209:etiology; D008297:Male; D008875:Middle Aged; D061646:Operative Time; D010149:Postoperative Pain / Q000209:etiology; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D011788:Quality of Life; D012008:Recurrence; D012086:Reoperation; D049291:Seroma / Q000209:etiology; D013526:Surgical Mesh / Q000009:adverse effects; D013530:Surgical Wound Infection / Q000209:etiology*