Wireless Electroceutical Dressing for the Treatment of Biofilm Infected Burn Patients

Introduction: Biofilms are clinically frustrating structures because within their extracellular polymeric substance (EPS) cocoons, bacteria are protected from antimicrobial attack and natural host defenses. The CDC estimates that 65% of all human infectious disease is caused by bacteria with a biofilm phenotype and NIH estimates that this number is closer to 80%. Despite advances in the use of topical and parenteral antimicrobial therapy and the practice of early tangential burn-wound excision to manage bacterial load, bacterial infection remains a major problem in the management of burn victims. The purpose of this clinical trial was to investigate the efficacy of an FDA cleared wireless electroceutical dressing (WED) against burn wound biofilm infection. The hypothesis was that a low electric field (~1V) generated by the moisture-activated WED would reduce biofilm severity and infection load. Methods: A phase I, prospective, randomized, controlled clinical trial was performed to evaluate the efficacy of the WED dressing compared to the standard of care (SoC) control dressing to prevent and disrupt biofilms. Subjects were screened from inpatient admissions to the Brooke Army Medical Center and US Army Institute of Surgical Research Burn Center in San Antonio, TX. Traumatic burns >300cm2 in size and distributed either in one contiguous area or two separate but similar areas were selected. In total 38 subjects were enrolled to the study. After obtaining informed consent, subject burn wounds were divided into two parts and randomized to receive either the SoC dressing or the WED dressing. Dressings were changed on day 4 and removed on day 7. Biopsies were collected on days 4 and 7 for blinded scanning electron microscopic (SEM) examination of biofilm and for semi-quantitative bacteriological analyses. Results: The results showed that short-term WED treatment significantly decreased biofilm severity in all burn wounds (grafted and non-grafted) analyzed. Furthermore, bacterial load was significantly lower in non-grafted burn wounds. The incidence of opportunistic pathogens such as Ralstonia pickettii and Serratia marcescens were significantly lower in WED treated wounds compared to SoC. Conclusion: This phase I clinical trial demonstrated that the WED promoted biofilm infection clearance better than SoC alone.