Efficacy and Safety of a Novel Autologous Wound Matrix in the Management of Complicated, Chronic Wounds: A Pilot Study.
| Autor: | Kushnir I; RedDress Ltd, Pardes Hanna, Israel., Kushnir A; RedDress Ltd, Pardes Hanna, Israel., Serena TE; Clinical Research, Serena Group Wound and Hyperbaric Centers, Warren, PA., Garfinkel D; Homecare Service, Israel Cancer Association and Geriatric-Palliative Service, Wolfson Medical Center, Holon, Israel. |
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| Jazyk: | angličtina |
| Zdroj: | Wounds : a compendium of clinical research and practice [Wounds] 2016 Sep; Vol. 28 (9), pp. 317-327. |
| Abstrakt: | Introduction: The objective of this pilot study was to evaluate the efficacy and safety of a novel method using an autologous whole blood clot formed with the RedDress Wound Care System (RD1, RedDress Ltd, Israel), a provisional whole blood clot matrix used in the treatment of chronic wounds of various etiologies. Methods and Materials: Patients were treated at the bedside with the whole blood clot matrix. Blood was withdrawn from each patient using citrate, mixed with a calcium gluconate/kaolin suspension, and injected into an RD1 clotting tray. Within 10 minutes, a clot was formed, placed upon the wound, and fixed with primary and secondary dressings. Wounds were redressed weekly with a whole blood clot matrix. Treatment was terminated when complete healing was achieved, or when the clinician determined that the wound could not further improve without additional invasive procedures. Results: Seven patients with multiple and serious comorbidities and 9 chronic wounds were treated with 35 clot matrices. Complete healing was achieved in 7 of 9 wounds (78%). In 1 venous ulcer with a nonhealing fistula, 77% healing was achieved. Treatment was terminated in 1 pressure ulcer at 82% closure, because an unexpected mechanical trauma resulted in deterioration; this was the only adverse event reported, unrelated to the product. No systemic adverse events occurred. Conclusions: This pilot study demonstrates the in vitro autologous whole blood clot matrix is effective and safe for treating patients with chronic wounds of different etiologies. A larger clinical trial is needed to assess the relative success rate of the matrix in different types of wounds in a diverse population with comorbidities. |
| Databáze: | MEDLINE |
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