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Zelen CM, Serena TE, Snyder RJ, et al.
International wound journal. Date of publication 2014 Apr 1;volume 11(2):122-8.
1. Int Wound J. 2014 Apr;11(2):122-8. doi: 10.1111/iwj.12242. Epub 2014 Feb 21. A prospective, randomised comparative study of weekly versus biweekly application of dehydrated human amnion/chorion membrane allograft in the management of diabetic foot ulcers. Zelen CM(1), Serena TE, Snyder RJ. Author information: (1)Department of Clinical Research, Professional Education and Research Institute, Inc., Roanoke, VA, USA. The aim of this study is to determine if weekly application of dehydrated human amnion/chorion membrane allograft reduce time to heal more effectively than biweekly application for treatment of diabetic foot ulcers. This was an institutional review board-approved, registered, prospective, randomised, comparative, non-blinded, single-centre clinical trial. Patients with non-infected ulcers of ≥ 4 weeks duration were included for the study. They were randomised to receive weekly or biweekly application of allograft in addition to a non-adherent, moist dressing with compressive wrapping. All wounds were offloaded. The primary study outcome was mean time to healing. Overall, during the 12-week study period, 92·5% (37/40) ulcers completely healed. Mean time to complete healing was 4·1 ± 2·9 versus 2·4 ± 1·8 weeks (P = 0·039) in the biweekly versus weekly groups, respectively. Complete healing occurred in 50% versus 90% by 4 weeks in the biweekly and weekly groups, respectively (P = 0·014). Number of grafts applied to healed wounds was similar at 2·4 ± 1·5 and 2·3 ± 1·8 for biweekly versus weekly groups, respectively (P = 0·841). These results validate previous studies showing that the allograft is an effective treatment for diabetic ulcers and show that wounds treated with weekly application heal more rapidly than with biweekly application. More rapid healing may decrease clinical operational costs and prevent long-term medical complications. © 2014 The Authors. International Wound Journal © published by Medicalhelplines.com Inc and John Wiley & Sons Ltd. DOI: 10.1111/iwj.12242 PMCID: PMC4235421 PMID: 24618401 [Indexed for MEDLINE]
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