(HE-009) Financial Assessment of a Novel Sharp Debridement Device Compared to Traditional Sharp Debridement Instrumentation for Biofilm Management in Chronic Non-healing Wounds

Francis Derk, DPM; Sandeep Gopalakrishnan, PhD, MAPWCA; Martha Kelso, RN; Jeffrey Niezgoda, MD, FACHM, MAPWCA, CHWS

Introduction:

Background: The gold standard in managing chronic wound biofilms is sharp debridement with evidence supporting cost-effective benefits in biofilm suppression and overall wound care costs. While traditional sharp debridement (TSD) is a standard treatment, its limitations include a lack of data on healing trajectories with associated costs. This study investigated a novel sharp debridement device (EZD) versus TDS in comparison of healing trajectories based on the Wu et at model using Alcian Blue and Biofilm Wound (BFW) Categorization along with a cost variable.

Methods:

Methods: This prospective study enrolled 80 patients with chronic wounds, randomized to either EZD sharp debridement (EZ-Debride, MDM Ventures, San Antonio, TX) or TSD (scalpels/curettes).  Biofilm presence and extent were assessed pre- and post-debridement using a modified Alcian Blue wound blotting technique and graded on a 0-3 scale.  Wu’s model was applied based in increments of 30, 90, and 180 day healing trajectories derived from the post debridement scale.  An evidence based wound care daily cost and unit retail cost of EZD and TSD instruments were then analyzed.

Results:

Results: EZD resulted in a significantly greater reduction in biofilm (84.97% vs. 34.87%, p < 0.0001) and clinical assessment confirmed a higher rate of complete biofilm removal in the EZD group (60% vs. 12.2%).  EZD resulted in 60% grade 0 BFW and 40% grade 1 BFW for an average expenditure cost including cost of instruments at $34,053.12. TSD resulted in 12.2% grade 0 BFW, 60% grade 1 BFW, and 25% grade 2 BFW and total of 14 wounds (35%) resulted in no biofilm removal in 8 wounds (20%), and an increase in biofilm in 6 wounds (15%) with a total cost of $55,485.00.

Discussion:

Conclusion: This study demonstrates that the novel sharp debridement device, EZD, is a safe and effective tool for biofilm removal in chronic wounds, potentially surpassing TSD methods in the eradication of biofilm.  EZD has shown to produce repeatable and reproducible results in this study with a profound impact of wound care cost and better healing trajectories based on biofilm presence. Further research should examine its impact on long-term healing and broader clinical applicability