title: Effectiveness of an extracellular matrix graft (OASIS Wound Matrix) in the treatment of chronic leg ulcers: a randomized clinical trial.
abstract: BACKGROUND
  Venous leg ulcers are a major cause of morbidity, economic loss, and decreased quality of life in affected patients. Recently, biomaterials derived from natural tissue sources have been used to stimulate wound closure. One such biomaterial obtained from porcine small-intestine submucosa (SIS) has shown promise as an effective treatment to manage full-thickness wounds. Our objective was to compare the effectiveness of SIS wound matrix with compression vs compression alone in healing chronic leg ulcers within 12 weeks.
  
  
  METHODS
  This was a prospective, randomized, controlled multicenter trial. Patients were 120 patients with at least 1 chronic leg ulcer. Patients were randomly assigned to receive either weekly topical treatment of SIS plus compression therapy (n = 62) or compression therapy alone (n = 58). Ulcer size was determined at enrollment and weekly throughout the treatment. Healing was assessed weekly for up to 12 weeks. Recurrence after 6 months was recorded. The primary outcome measure was the proportion of ulcers healed in each group at 12 weeks.
  
  
  RESULTS
  After 12 weeks of treatment, 55% of the wounds in the SIS group were healed, as compared with 34% in the standard-care group (P = .0196). None of the healed patients treated with SIS wound matrix and seen for the 6-month follow-up experienced ulcer recurrence.
  
  
  CONCLUSIONS
  The SIS wound matrix, as an adjunct therapy, significantly improves healing of chronic leg ulcers over compression therapy alone.
authors.affiliation: Akron General Medical Center, Northeastern Ohio University College of Medicine, USA. emostow@neoucom.edu
authors.forename: Eliot N
authors.initials: EN
authors.lastname: Mostow
authors.forename: G Davin
authors.initials: GD
authors.lastname: Haraway
authors.forename: Michael
authors.initials: M
authors.lastname: Dalsing
authors.forename: Jason P
authors.initials: JP
authors.lastname: Hodde
authors.forename: Dennis
authors.initials: D
authors.lastname: King
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001684:Biological Dressings; D002908:Chronic Disease; D018592:Cross-Over Studies; D005109:Extracellular Matrix; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007871:Leg Ulcer / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome; D014945:Wound Healing / Q000502:physiology