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Niezgoda JA, Van Gils CC, Frykberg RG, Hodde JP, et al.
Advances in skin & wound care. Date of publication 2005 Jun 1;volume 18(5 Pt 1):258-66.
1. Adv Skin Wound Care. 2005 Jun;18(5 Pt 1):258-66. Randomized clinical trial comparing OASIS Wound Matrix to Regranex Gel for diabetic ulcers. Niezgoda JA(1), Van Gils CC, Frykberg RG, Hodde JP. Author information: (1)Center for Comprehensive Wound Care and Hyperbaric Oxygen Therapy, St. Luke's Medical Center, Milwaukee, WI, USA. Comment in Adv Skin Wound Care. 2006 Mar;19(2):64; author reply 64, 67. OBJECTIVE: To compare healing rates at 12 weeks for full-thickness diabetic foot ulcers treated with OASIS Wound Matrix, an acellular wound care product, versus Regranex Gel. DESIGN: Randomized, prospective, controlled multicenter trial at 9 outpatient wound care clinics. SUBJECTS: A total of 73 patients with at least 1 diabetic foot ulcer were entered into the trial and completed the protocol. INTERVENTION: Patients were randomized to receive either OASIS Wound Matrix (n = 37) or Regranex Gel (n = 36) and a secondary dressing. Wounds were cleansed and debrided, if needed, at a weekly clinic visit. Dressings were changed as needed. The maximum treatment period for each patient was 12 weeks. PRIMARY OUTCOME MEASURE: Incidence of healing in each group at 12 weeks. RESULTS: After 12 weeks of treatment, 18 (49%) OASIS-treated patients had complete wound closure compared with 10 (28%) Regranex-treated patients. CONCLUSION: Although the sample size was not large enough to demonstrate that the incidence of healing in the OASIS group was statistically superior (P = .055), the study results showed that treatment with OASIS is as effective as Regranex in healing full-thickness diabetic foot ulcers by 12 weeks. PMID: 15942317 [Indexed for MEDLINE]
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