Study to Evaluate PowerHeal22 Bioelectric Bandage for Healing and Managing Infected Traumatic Wounds

What this Trial Is About

This research aims to evaluate whether the PowerHeal Bioelectric Bandage, a wireless electroceutical dressing, can improve healing of infected traumatic wounds by promoting wound closure and managing infection. The study focuses on wounds that are challenging due to bacterial infections, including multidrug resistant strains, especially in military and civilian patients in Ukraine. Researchers will compare this bioelectric bandage to standard wound care dressings to see if it enhances healing and infection control. Participants will be randomly assigned to one of two groups one receiving standard of care dressings, and the other receiving the standard care plus the PowerHeal Bioelectric Bandage. The bandage produces a gentle electric field and reactive molecules in the wound area to help clear infection and support healing. Dressings will be changed according to wound fluid levels, with more frequent changes early on and less frequent later. Each participant is expected to use at least 15 of these bandages over the 28-day study period. During the study, participants will have five visits over about 28 days. At each visit, the wound will be photographed and measured, and a swab sample taken to check infection status and microbial types. Vital signs and signs of infection such as redness, swelling, and pain will also be monitored. Laboratory tests and medical history will be collected to assess overall health, but no blood samples are taken specifically for this study. Researchers will track changes in wound size and infection to evaluate the bandages effects.

Healing Electroceutical Dressing for the Recovery of Open Wounds (HERO)