Efficacy and Safety of a Novel Autologous Wound Matrix in the Management of Complicated, Chronic Wounds: A Pilot Study

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, Red Dress 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 Blood was withdrawn from each patient using Citrate; mixed with a calcium gluconate/kaolin suspension, and injected into an RD1 clotting tray.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.