NCT07329114

Brief Summary

The goal of this clinical trial is to determine whether the wireless electroceutical dressing (WED) called PowerHeal™ Bioelectric Bandage, improves care of infected wounds by clearing the infection and helping the wound heal better. The main hypotheses it aims to answer are:

  1. 1.WED promotes wound closure, as determined by wound area measurement
  2. 2.WED manages wound infection in civilian and military wounds in Ukraine, as determined by clinical assessment of wound infection by measuring the numbers and types of relevant microbes.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
12mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Feb 2026Aug 2027

First Submitted

Initial submission to the registry

January 7, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

February 11, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

1.4 years

First QC Date

January 7, 2026

Last Update Submit

March 4, 2026

Conditions

Wound InfectionWound Healing DelayedWound of SkinInfectionsWound Heal

Keywords

bandage

Outcome Measures

Primary Outcomes (1)

  • change in wound area

    Assess the efficacy of WED in promoting wound closure. The digital photos taken at all visits will be quantitatively evaluated using ImageJ software that can measure the wound area. These measurements will be used for detailed analysis of wound closure over the period of study. Percentage decrease in wound area compared to SOC - from baseline (day 0) to final visit (day 28,± 2 days) will be calculated and analyzed, thus comparing range and rate of change between the two groups SOC and SOC + PowerHeal™ Bioelectric Bandage in aggregate. Adjustment for the correlated variance due to repeated measures will be made throughout the analysis. All analysis will be conducted at 0.05 level of significance.

    28 days (± 2 days)

Secondary Outcomes (1)

  • Change in microbial population - types of strains and numbers of colonies

    28 days (± 2 days)

Study Arms (2)

Standard of Care (SOC) Group

ACTIVE COMPARATOR

The choice of wound dressing and timing of dressing changes will be determined by the investigation doctor until the participant's wound heals, or until the participant is discharged.

Device: Standard of care dressing

SOC + PowerHeal™ Bioelectric Bandage Group

EXPERIMENTAL

* The first SOC + PowerHeal™ Bioelectric Bandage will be applied within 24 hours of randomization. * Each participant is expected to need at least 15 PowerHeal™ Bioelectric Bandages throughout the study. PowerHeal™ Bandage Change Schedule Dressing change frequency depends on how much fluid (exudate) the wound produces. * Day 0-7 and Day 7-14: Minimum of 2 times per week, up to every other day. * Day 14-28: Minimum of once per week, more as needed dependent on wound exudate.

Device: PowerHeal™ Bioelectric BandageDevice: Standard of care dressing

Interventions

Standard of care dressingDEVICE

SOC will be determined by local established guidelines and participant needs. This may include sutures, staples, liquid skin adhesives, adhesive surgical tape, gauze dressings and negative pressure wound therapy treatment strategies.

SOC + PowerHeal™ Bioelectric Bandage GroupStandard of Care (SOC) Group
PowerHeal™ Bioelectric BandageDEVICE

PowerHeal™ Bioelectric Bandage is a flexible fabric electroceutical based wound bandage offering ease of portability with long shelf life and stable for storage under any conditions. PowerHeal™ Bioelectric Bandage may be preventively used on fresh wounds. PowerHeal™ Bioelectric Bandage can directly disrupt the biofilm infection and enhance host resilience such as restoring skin barrier function (10). Productive management of bacterial biofilm/MDR infection or risk of such infection will minimize healing complications. This will result in fewer treatments and corrective procedures and earlier return to daily life for patients with traumatic wounds/burns.

Also known as: wireless electroceutical dressing (WED)
SOC + PowerHeal™ Bioelectric Bandage Group

Eligibility Criteria

Age18 Years - 105 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female and male participants 18-105 years of age
  • Hospital admission (or boarding in an emergency department or other area awaiting hospital admission) at participating clinical sites in Ukraine
  • At least one infected traumatic wound(s) between 20-40 cm2 in size. Probable or confirmed wound infection(s) will be determined by on-site physicians' clinical judgment and the presence of two or more of the following clinical indicators of wound infection:
  • Presence of worsening pain (from the moment of injury)
  • Erythema (redness)
  • Warmth (heat)
  • Edema (swelling)
  • Purulent exudate (drainage)
  • Delayed healing
  • Discoloration
  • Friable granulation
  • Foul odor
  • Wound margin breakdown or necrosis with or without fever
  • Pustules, vesicles, boils
  • Participant or legal representative provides written informed consent prior to investigation procedures
  • +1 more criteria

You may not qualify if:

  • Allergy to silver or zinc
  • Women who are pregnant or nursing
  • Women of childbearing potential without a documented negative pregnancy test during the current hospitalization or women of childbearing potential who refused pregnancy testing during screening
  • Sponsor or contract research organization (CRO) staff directly involved in the conduct of the investigation, and site staff supervised by the investigator, and their respective family members
  • \> 60 days from the initial traumatic injury
  • Known prisoner
  • The patient is expected to be discharged from the hospital within the next 24 hours
  • Medical condition other than the acute traumatic wound (and its manifestations) that is likely to result in death within 14 days of randomization
  • Moribund condition, defined as life expectancy less than 48 hours from randomization
  • Patients undergoing comfort care measures only such that treatment focuses on end-of-life symptom management over prolongation of life
  • Expected inability or unwillingness to participate in study procedures
  • In the opinion of the investigator, participation in the investigation is not in the best interest of the patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ivano-Frankivsk Central Clinical Hospital

Ivano-Frankivsk, 76000, Ukraine

RECRUITING

Related Publications (3)

  • Schultze T, Hogardt M, Velazquez ES, Hack D, Besier S, Wichelhaus TA, Rochwalsky U, Kempf VA, Reinheimer C. Molecular surveillance of multidrug-resistant Gram-negative bacteria in Ukrainian patients, Germany, March to June 2022. Euro Surveill. 2023 Jan;28(1):2200850. doi: 10.2807/1560-7917.ES.2023.28.1.2200850.

    PMID: 36695452BACKGROUND

  • Banerjee J, Das Ghatak P, Roy S, Khanna S, Sequin EK, Bellman K, Dickinson BC, Suri P, Subramaniam VV, Chang CJ, Sen CK. Improvement of human keratinocyte migration by a redox active bioelectric dressing. PLoS One. 2014 Mar 3;9(3):e89239. doi: 10.1371/journal.pone.0089239. eCollection 2014.

    PMID: 24595050BACKGROUND

  • Banerjee J, Das Ghatak P, Roy S, Khanna S, Hemann C, Deng B, Das A, Zweier JL, Wozniak D, Sen CK. Silver-zinc redox-coupled electroceutical wound dressing disrupts bacterial biofilm. PLoS One. 2015 Mar 24;10(3):e0119531. doi: 10.1371/journal.pone.0119531. eCollection 2015.

    PMID: 25803639BACKGROUND

MeSH Terms

Conditions

Wound InfectionInfections

Study Officials

  • Chandan K. Sen, PhD, MS

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shomita S Steiner, PhD, MS

CONTACT

(463) 237-8770SSTEINER@pitt.edu

Piya Das Ghatak, PhD, MS

CONTACT

pid12@pitt.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: How well the PowerHeal™ Bioelectric Bandage-a special wireless bandage that uses gentle electrical signals-helps heal infected wounds caused by injuries, will be tested. The study will take place at a minimum of three medical sites in Ukraine, with support and training from experts in the United States at the University of Colorado and the University of Pittsburgh. All teams will stay in close contact throughout the study. This international collaboration aims to find out if this new type of bandage can reduce infections and speed up healing for people with serious wounds.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 7, 2026

First Posted

January 9, 2026

Study Start

February 11, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

March 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

UA(1)