Clinical Research

(CR-023) Comparison of Copper Oxide Dressings (COD) to Negative Pressure Wound Therapy (NPWT) - Preliminary results of wound healing parameters in a randomized controlled trial

Co-Author(s):

Gadi Borkow, PhD – MedCu Technologies; Jihad Dabach, MD – Rambam Health Care Campus

Introduction: Negative Pressure Wound Therapy (NPWT) is the standard of care for treating large and deep wounds, with randomized control trials (RCT) favoring its use to fill the deep cavities and enhance wound closure. Copper Oxide Dressings (COD) have been recently introduced into clinical practice due to their antimicrobial properties. Basic science research and clinical experience showed their positive effect also in inducing wound healing, including stimulation of autolytic debridement, granulation tissue formation and epithelization. Methods: We initiated a randomized controlled trial with 60 diabetic patients comparing the reduction of wound size during 3 months of treatment between COD management to NPWT, as the primary end point, by using an artificial intelligence program (Tissue Analytics). Results: Analysis of preliminary results demonstrate similar increase in granulation tissue and reduction in wound size in both study arms, indicating at least non-inferiority of the COD treatment as compared to the NPWT. For the given number of patients that have completed the trial so far (n=14), the statistical non-inferiority calculation (p=0.001; Friedman Repeated Measures Analysis of Variance on Ranks) indicate a 60% probability that the finding will remain statistically significant by the end of the study (The updated statistics for the patients that will finish the study by the end of September 2022 will be presented in the conference). Discussion: The use of COD for the management of diabetic wounds achieves similar increase in granulation tissue and reduction in wound size as NPWT. There are several benefits of using the COD than NPWT, such as convenience to the patients and staff, reduced costs, etc. raising the possibility of using the COD instead of NPWT for the management of diabetic foot wounds. Trademarked Items: References: 1. Melamed, E., Kiambi, P., Okoth, D., Honigber, I., Tamir, E., and Borkow, G. (2021) Healing of Chronic Wounds by Copper Oxide-Impregnated Wound Dressings – Case Series. Medicina 57, 296. https://doi.org/10.3390/
2. Borkow, G., Melamed, E. (2021) Copper, an abandoned player returning to the wound healing battle. In: Recent Advances in Wound Healing. Ed: Shahin Aghaei; IntechOpen London: 5 Princes Gate Court, London, SW7 2QJ, UK. ISBN: 978-1-83968-572-9
3. Ogen-Shtern, N., Chumin, K., Silberstein, E., Borkow, G. (2021) Copper ions ameliorated thermal burn-induced damage in ex-vivo human skin organ culture. Skin Pharmacology and Physiology 34(6):317-327. doi: 10.1159/000517194.
4. Melamed E., Rovitsky, A., Roth, T., Assa, L., Borkow, G. (2021) Stimulation of Healing of Non-Infected Stagnated Diabetic Wounds by Copper Oxide-ImpregnatedWound Dressings. Medicina 57(10):1129. doi: 10.3390/medicina57101129.
5. Weitman, C.C., Roth, T., Borkow, G. (2022) Copper to the wound rescue after everything else failed: Case Report. Archives of Clinical and Medical Case Reports 6 (3): 459-466.