Introduction:
Burn injuries are common to all military conflicts causing approximately 5 to 10% of all war casualties. In combat, eradication and prevention of burn wound infection is complicated by high rates of soft tissue contamination and prolonged delays to definitive stateside care. Serious burns often result in invasive infection that can progress to septic shock and death. Furthermore, in the battlefield setting the salvage rate for infected burned extremities is low. Therefore, a simple, easy, non-invasive and rapid method to protect the wound, while also inhibiting infection, would represent a significant advance in the treatment of combat burn wounds. Therefore, the purpose of this clinical trial was to investigate the efficacy of an FDA cleared disposable and easily portable, lightweight, wireless electroceutical dressing (WED) in the treatment of burn wounds. The hypothesis was that a low electric field (~1V) generated by the moisture-activated WED will reduce infection load, enhance wound healing and restore skin barrier function of biofilm infected wounds.

Methods:
A phase I, prospective, randomized, controlled clinical trial was performed to evaluate the efficacy of the WED as compared to the standard of care (SoC) control dressing to prevent and disrupt biofilms. Subjects were screened from inpatient admissions to the San Antonio Military Medical Center, and the United States Army Institute of Surgical Research Burn Center for traumatic burns >300cm2 in size, distributed either in one contiguous area or two separate but similar areas. 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, removed on day 7 and the burn wounds were followed for 30 days. Small biopsies were collected on days 4 and 7 for histology, scanning electron microscopy (SEM) examination of biofilm and for quantitative bacteriological analyses was performed in a blinded manner. In addition, non-invasive wound imaging techniques (Silhouette StarTM camera; DermaLab Combo) were utilized to study wound healing. Furthermore, Vancouver scar scale (VSS) and patient observer scar assessment (POSAS) were used to evaluate quality of healing.

Results:
The results showed that at the time of dressing removal (day 7), non-grafted burn wounds that were treated with the WED dressing presented statistically significantly less biofilm in comparison to the SoC treated wounds (p < 0.05). The results also demonstrated that the WED dressing was more efficient at eradicating biofilm than the SoC dressing. At the time of the dressing removal, biofilm score [0-3] had decreased in 48% of the WED dressing treated burns in comparison to 28% in the SoC treated burns. In terms of wound healing and quality of healing no statistically significant differences were observed between the WED and the SoC dressings.

Conclusion:
This phase I clinical trial demonstrated that the WED dressing was more efficient against biofilm infection that the SoC dressing. In addition, the study concluded that the WED dressing performed equally well as the SoC in terms of burn wound healing.