title: Pilot study evaluating the efficacy of AlloMEM™ for prevention of intraperitoneal adhesions and peritoneal regeneration after loop ileostomy.
abstract: OBJECTIVE
  This study was designed to evaluate the feasibility of AlloMEM™, a novel lyophililzed human peritoneal membrane, at peritoneal reconstitution, and decreasing adhesion formation after temporary loop ileostomy.
  
  
  METHODS
  In a pilot study, ten patients had AlloMEM™ used during elective formation of a temporary diverting loop ileostomy for benign or malignant colorectal disease. A blinded investigator and the operating surgeon analyzed the change in adhesion formation and peritoneal remodelling using ileostomy mobilization time and a 5-point adhesion scale grading intra-abdominally and at the subcutaneous and fascial levels.
  
  
  RESULTS
  The mean body mass index was 31 [standard deviation (SD) 5.6], and 40 % of patients had previous abdominal surgery. Ileostomies were reversed after a mean 14 weeks (SD 6.0). The mean ileostomy mobilization time was 27.2 min (SD 12.0). From baseline to ileostomy reversal, there were significant increases in adhesions at the subcutaneous (p = 0.0002) and fascial levels (p = 0.0024). The increased subcutaneous adhesions were associated with improved peritoneal remodeling. There was no significant increase in adhesions from baseline to ileostomy reversal at the intra-abdominal points (p = 0.9393) or around the ileostomy site (p = 0.6128). The median hospital length of stay was 2.6 days (range, 2-3). A single adverse event related to product packaging led to redesign of the packaging process.
  
  
  CONCLUSIONS
  Use of AlloMEM™ in ileostomy closures suggested improvement in adhesions around the fascia and promotion of peritoneal remodeling. AlloMEM™ was safe, feasible, and easy to use in this pilot study. Comparative research is needed to assess the outcomes with this novel product.
authors.affiliation: Division of Colorectal Surgery, Department of Surgery, Institute for Surgery and Innovation, University Hospitals Case Medical Center, Case Western Reserve University, 11100 Euclid Avenue, 7 Lakeside, Cleveland, OH, 44106-5047, USA, Deborah.Keller@uhhospitals.org.
authors.forename: Deborah S
authors.initials: DS
authors.lastname: Keller
authors.forename: Bradley J
authors.initials: BJ
authors.lastname: Champagne
authors.forename: Sharon L
authors.initials: SL
authors.lastname: Stein
authors.forename: Bridget O
authors.initials: BO
authors.lastname: Ermlich
authors.forename: Conor P
authors.initials: CP
authors.lastname: Delaney
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D064591:Allografts; D001705:Bioprosthesis; D003082:Colectomy; D003093:Colitis, Ulcerative / Q000601:surgery; D017558:Elective Surgical Procedures; D000071938:Fasciotomy; D005240:Feasibility Studies; D005260:Female; D005612:Freeze Drying; D006801:Humans; D007081:Ileostomy; D007415:Intestinal Obstruction / Q000517:prevention & control; D007417:Intestinal Polyps / Q000601:surgery; D008297:Male; D008875:Middle Aged; D010537:Peritoneum / Q000502:physiology* / Q000637:transplantation; D010865:Pilot Projects; D011183:Postoperative Complications / Q000517:prevention & control; D011446:Prospective Studies; D012004:Rectal Neoplasms / Q000601:surgery; D012038:Regeneration; D016037:Single-Blind Method; D000267:Tissue Adhesions / Q000209:etiology / Q000517:prevention & control*; D014021:Tissue Preservation; D058106:Wound Closure Techniques