title: Early report of a randomized comparative clinical trial of Strattice™ reconstructive tissue matrix to lightweight synthetic mesh in the repair of inguinal hernias.
abstract: OBJECTIVE
  Biologic grafts are rarely used for inguinal herniorrhaphy. The aim of this study was to compare the clinical outcomes between patients undergoing a Lichtenstein's hernioplasty with a porcine mesh versus a standard synthetic.
  
  
  METHODS
  A prospective, randomized, double-blinded multicenter, evaluation of inguinal hernia repair was conducted between 2008 and 2010. Lichtenstein hernioplasty was performed using Strattice™ or lightweight polypropylene (Ultrapro) mesh. Quality of life, pain, overall complication rate, and recurrence were measured.
  
  
  RESULTS
  One hundred and seventy-two patients were randomized to Strattice™ (n = 84) or Ultrapro (n = 88). At 3 months postoperatively, there were no differences on the occurrence or type of wound events [RR: 0.98 (95% CI 0.52-1.86, p = 0.69), Strattice™ (15 events) vs. Ultrapro (16 events)]. The mean level of impairment caused by the hernia, assessed by Activities Assessment Scale (AAS), significantly decreased postoperatively in both groups at 3 months (31% Strattice™ and 37% Ultrapro). Patients in the Strattice group reported significantly less postoperative pain during postoperative days 1 through 3 compared to Ultrapro patients. However, the amount of postoperative pain at 3 months, as assessed by the mean worst pain score on a visual analog scale and the Brief Pain Index, was similar between groups (95% CI 1.0-29.3). No hernia recurrences were observed in either group.
  
  
  CONCLUSIONS
  Strattice™ is safe and effective in repairing inguinal hernia, with comparable intra-operative and early postoperative morbidity to synthetic mesh. Long-term follow-up is necessary in order to know whether the clinical outcomes of Strattice are equivalent to standard synthetic mesh in patients undergoing Lichtenstein's hernioplasty.
authors.affiliation: Department of Surgery SL-22, Tulane University, 1430 Tulane Ave, New Orleans, LA, 70115, USA, cbellows@tulane.edu.
authors.forename: C F
authors.initials: CF
authors.lastname: Bellows
authors.forename: P
authors.initials: P
authors.lastname: Shadduck
authors.forename: W S
authors.initials: WS
authors.lastname: Helton
authors.forename: R
authors.initials: R
authors.lastname: Martindale
authors.forename: B C
authors.initials: BC
authors.lastname: Stouch
authors.forename: R
authors.initials: R
authors.lastname: Fitzgibbons
mesh_terms: D003094:Collagen / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006552:Hernia, Inguinal / Q000601:surgery*; D059685:Herniorrhaphy / Q000379:methods*; D006801:Humans; D007902:Length of Stay / Q000706:statistics & numerical data; D008297:Male; D008875:Middle Aged; D061646:Operative Time; D010147:Pain Measurement; D010149:Postoperative Pain / Q000517:prevention & control; D011126:Polypropylenes; D011183:Postoperative Complications / Q000453:epidemiology; D011788:Quality of Life; D012008:Recurrence; D012307:Risk Factors; D013526:Surgical Mesh; D016896:Treatment Outcome
chemical_list: D011126:Polypropylenes; C568444:strattice; D003094:Collagen
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