TY - JOUR
T1 - Placental Membrane Provides Improved Healing Efficacy and Lower Cost Versus a Tissue-Engineered Human Skin in the Treatment of Diabetic Foot Ulcerations
AU - Glat, Paul
AU - Orgill, Dennis P.
AU - Galiano, Robert
AU - Armstrong, David
AU - Serena, Thomas
AU - Didomenico, Lawrence A.
AU - Kaufman, Jarrod
AU - Carter, Marissa J.
AU - Jacobs, Alan M.
AU - Zelen, Charles M.
N1 - Funding Information:
From the *Drexel University, Philadelphia, Pa.; †Division of Plastic Surgery, Brigham and Women’s Hospital, Boston, Mass.; ‡Department of Plastic Surgery, Northwestern University Feinberg School of Medicine, Chicago, Ill.; §SALSA, Department of Surgery, Keck School of Medicine of University of Southern California; ¶Serena Group, Cambridge, Mass.; ║Lower Extremity Institute for Research and Therapy, Youngstown, Ohio; **Premier Surgical, Brick, N.J.; ††Strategic Solutions, Inc., Cody, Wyo.; ‡‡Alan M Jacobs and Associates, St. Louis, Miss.; and §§Professional Education and Research Institute, Inc., Roanoke, Va. Received for publication December 3, 2018; accepted June 7, 2019. Presented at the Society for Advanced Wound Care, November, 2018, Las Vegas, NV. Supported by MTF Biologics, Edison, NJ. Dehydrated human amnion and chorion allograft (AmnioBand; MTF Biologics, Edison, NJ) is aseptically processed amnion and chorion that is approved for use under the FDA HCT/P, 21 CFR 1271 regulations on homologous use of human tissue. Tissue- engineered skin substitute (Apligraf; Organogenesis, Canton, MA) is an FDA-approved engineered tissue skin substitute approved with PMA Number P950032 05/22/98 for use with standard diabetic foot ulcer care for the treatment of full-thickness neuropathic diabetic foot ulcer of greater than 3 weeks in duration, which have not adequately responded to conventional ulcer therapy. This trial was registered on Clinical Trials.Gov (ClinicalTrials.gov Identifier: NCT02870816). This trial was approved by the Western Institutional Review Board, Pullup, WA (WIRB Protocol Number: 20161439-MTF-DFU-ABAG-01). Copyright © 2019 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of The American Society of Plastic Surgeons. This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.
Publisher Copyright:
© 2019 Lippincott Williams and Wilkins. All rights reserved.
PY - 2019
Y1 - 2019
N2 - Background: Aseptically processed dehydrated human amnion and chorion allograft (dHACA) (AmnioBand) has shown great promise in the treatment of recalcitrant diabetic foot ulcers (DFUs) when compared with standard wound care but has not yet been compared to any other tissue forms used in treating DFUs. The hypothesis was to conduct a randomized controlled trial in which dHACA was compared to one of the earliest and most commonly accepted tissue-engineered skin substitutes (TESS) (Apligraf) in the treatment of nonhealing DFUs over a period of 12 weeks to assess the superiority of healing. Methods: Following a 2-week screening period during which subjects with DFUs were treated with collagen alginate dressing, 60 subjects were randomized at 5 sites to receive either dHACA or TESS applied weekly, with weekly follow-up for up to 12 weeks. Results: The mean time to heal within 6-week time period for the dHACA group was 24 days (95% CI, 18.9-29.2) versus 39 days (95% CI, 36.4-41.9) for the TESS group; the mean time to heal at 12 weeks was 32 days (95% CI, 22.3-41.0) for dHACA-treated wounds versus 63 days (95% CI, 54.1-72.6) for TESS-treated wounds. The proportion of wounds healed at study completion (12 weeks) was 90% (27/30) for the dHACA group versus 40% (12/30) for the TESS group. The mean product cost for the dHACA group was significantly lower than that for the TESS group [dHACA: $2,200 (median: $1,300); TESS: $7,900 (median: $6,500)]. The mean wastage (%) at 12 weeks was also significantly lower for the dHACA group than that for the TESS group (36% vs 95%). Conclusions: It was concluded that aseptically processed dHACA heals diabetic foot wounds more reliably, statistically significantly faster than and at significantly lower cost than TESS.
AB - Background: Aseptically processed dehydrated human amnion and chorion allograft (dHACA) (AmnioBand) has shown great promise in the treatment of recalcitrant diabetic foot ulcers (DFUs) when compared with standard wound care but has not yet been compared to any other tissue forms used in treating DFUs. The hypothesis was to conduct a randomized controlled trial in which dHACA was compared to one of the earliest and most commonly accepted tissue-engineered skin substitutes (TESS) (Apligraf) in the treatment of nonhealing DFUs over a period of 12 weeks to assess the superiority of healing. Methods: Following a 2-week screening period during which subjects with DFUs were treated with collagen alginate dressing, 60 subjects were randomized at 5 sites to receive either dHACA or TESS applied weekly, with weekly follow-up for up to 12 weeks. Results: The mean time to heal within 6-week time period for the dHACA group was 24 days (95% CI, 18.9-29.2) versus 39 days (95% CI, 36.4-41.9) for the TESS group; the mean time to heal at 12 weeks was 32 days (95% CI, 22.3-41.0) for dHACA-treated wounds versus 63 days (95% CI, 54.1-72.6) for TESS-treated wounds. The proportion of wounds healed at study completion (12 weeks) was 90% (27/30) for the dHACA group versus 40% (12/30) for the TESS group. The mean product cost for the dHACA group was significantly lower than that for the TESS group [dHACA: $2,200 (median: $1,300); TESS: $7,900 (median: $6,500)]. The mean wastage (%) at 12 weeks was also significantly lower for the dHACA group than that for the TESS group (36% vs 95%). Conclusions: It was concluded that aseptically processed dHACA heals diabetic foot wounds more reliably, statistically significantly faster than and at significantly lower cost than TESS.
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U2 - 10.1097/GOX.0000000000002371
DO - 10.1097/GOX.0000000000002371
M3 - Article
C2 - 31592387
AN - SCOPUS:85079607524
VL - 7
JO - Plastic and Reconstructive Surgery - Global Open
JF - Plastic and Reconstructive Surgery - Global Open
SN - 2169-7574
IS - 8
M1 - e2371
ER -