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

Sponsor
Chandan Sen
Study ID
NCT07329114
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 105 Years
Healthy Volunteers
Not accepted

Interventions

  • PowerHeal™ Bioelectric Bandage — DEVICE
    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.
  • Standard of care dressing — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Jan 9, 2026
Start date
Feb 11, 2026
Status verified
Mar 2026
Primary completion
Jul 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard of Care (SOC) Group
    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.
  • Experimental: SOC + PowerHeal™ Bioelectric Bandage Group
    * 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.

Primary Outcome Measure

change in wound area [ Time Frame: 28 days (± 2 days) ]

Central Contacts

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