Molecular surveillance of multidrug-resistant Gram-negative bacteria in Ukrainian patients, Germany, March to June 2022.
Tilman Schultze, Michael Hogardt, Erwin Sanabria Velázquez...
https://pubmed.ncbi.nlm.nih.gov/36695452Actively Recruiting
Phase Not Applicable
Age: 18Years - 105Years
All Genders
ID07329114
Evaluation of PowerHeal™ Bioelectric Bandage for Managing Infected Traumatic Wounds Compared to Standard Care Dressings
Led by Chandan Sen · Updated on 2026-03-06
150
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
C
Chandan Sen
Lead Sponsor
U
University of Colorado, Denver
Collaborating Sponsor
AI-Summary
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 bandage's effects.
CONDITIONS
Brief Title
Healing Electroceutical Dressing for the Recovery of Open Wounds (HERO)
Who Can Participate
Age: 18Years - 105Years
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 105 years
- Hospital admission or boarding in an emergency department at participating sites in Ukraine
- At least one infected traumatic wound between 20 and 40 cm2 in size
- Signs of wound infection including at least two of the following: worsening pain, redness, warmth, swelling, drainage, delayed healing, discoloration, friable granulation, foul odor, necrosis, pustules, vesicles, or boils
- Written informed consent provided
- Ability and agreement to follow study procedures
You will not qualify if you...
- Allergy to silver or zinc
- Pregnant or nursing women
- Women of childbearing potential without a recent negative pregnancy test or who refuse testing
- Staff involved in the study or their family members
- More than 60 days since the initial traumatic injury
- Known prisoners
- Expected hospital discharge within 24 hours
- Other medical conditions likely to cause death within 14 days
- Life expectancy less than 48 hours
- Receiving comfort care only
- Expected inability or unwillingness to participate
- Investigator judgment that participation is not in the patient's best interest
- Allergies to parabens or acrylates should avoid enrollment though not direct exclusions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 28 ± 2 days
Participants receive either the PowerHeal™ Bioelectric Bandage or standard of care dressings to manage infected traumatic wounds. Dressing change frequency depends on wound exudate and group assignment.
5 visits over the course of treatment
Trial Site Locations
Total: 1 location
1
Ivano-Frankivsk Central Clinical Hospital
Ivano-Frankivsk, Ukraine, 76000
Actively Recruiting
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Research Team
S
Shomita S Steiner, PhD, MS
P
Piya Das Ghatak, PhD, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Improvement of human keratinocyte migration by a redox active bioelectric dressing.
Jaideep Banerjee, Piya Das Ghatak, Sashwati Roy...
https://pubmed.ncbi.nlm.nih.gov/24595050Silver-zinc redox-coupled electroceutical wound dressing disrupts bacterial biofilm.
Jaideep Banerjee, Piya Das Ghatak, Sashwati Roy...
https://pubmed.ncbi.nlm.nih.gov/25803639