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Medicine: Evidence-Based Research: Plenary Session
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Moderator: George T. Rodeheaver, PhD Abstract This session will present new evidence-based data from recently performed clinical trails to be chosen before the meeting. Dr. Rodeheaver will moderate the session and provide introductions where appropriate. (Presentation 23.4) Adjunctive bioengineered bilayered cell therapy* with revascularization improves wound healing and limb salvage in critical limb ischemia David E. Allie; Chris J. Hebert; Mitchell D. Lirtzman; Charles H. Wyatt; V. Antoine Keller; Mohamed H. Khan; Muhammad A. Khan; Stella M. Souther; Elena V. Mitran; Adam A. Allie; Craig M. Walker, Cardiovascular Institute of the South/Lafayette, Lafayette, La Background: Advanced critical limb ischemia (CLI) patients (Rutherford Class 5–6 with established tissue loss) still report 25% major amputation rates at 12-months even after revascularization. Bioengineered bilayered cell therapy*, approved for treatment in venous and diabetic ulcers, is reported to improve wound healing and stimulate epithelization by increasing growth factors and promoting angiogenesis while providing a biological barrier against wound infection. Methods: Between January 1, 1999 and August 31, 2004, 68 CLI patients presented with open ischemic wounds and underwent revascularization [percutaneous 60/68 (88.2%) and surgical 8/68 (11.8%)]. Twenty nine of 68 patients (42.6%) underwent traditional wound care (TWC), including debridement and multiple topical therapies. Thirty nine of 68 patients (57.4%) had primary wound treatment with Apligraf. A retrospective multivariable analysis was performed, including wound size, location, time to wound healing (TWH), 6-month limb salvage (LS), and wound treatment (TWC vs. Apligraf). Results: Time to wound healing ranged from 18–89 days (mean = 51) in the Apligraf group and 31–138 days (mean = 84) in the TWC group. The 6-month LS rates for the Apligraf and TWC groups were 36/39 (92.3%) and 23/29 (79.3%), respectively. Seven of 39 patients (17.9%) required repeat Apligraf applications. Conclusion: Adjunctive bioengineered bilayered cell therapy significantly improves TWH and 6-month LS in CLI patients post revascularization. * Apligraf® is a registered trademark of Organogenesis, Inc., Canton, Mass |
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