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

NCT07329114 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-03-06

No results posted yet for this study

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. WED promotes wound closure, as determined by wound area measurement
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.

Researchers will compare to see if PowerHeal™ Bioelectric Bandage the dressing used in the SOC group

Participants will get their dressings changed per the protocol, wound image and swab will be taken.

Conditions

  • Wound Heal
  • Wound Infection
  • Wound Healing Delayed
  • Wound of Skin
  • Infections

Interventions

DEVICE

PowerHeal™ Bioelectric Bandage

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.

DEVICE

Standard of care dressing

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.

Sponsors & Collaborators

  • University of Colorado, Denver

    collaborator OTHER

  • Chandan Sen

    lead OTHER

Principal Investigators

  • Chandan K. Sen, PhD, MS · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
105 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-11
Primary Completion
2027-07-31
Completion
2027-08-31
FDA Device
Yes

Countries

  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07329114 on ClinicalTrials.gov