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RECRUITING

NCT07329114

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

Sponsor: Chandan Sen

View on ClinicalTrials.gov

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.

Official title: Prospective, Unblinded, Randomized, Controlled Investigation to Evaluate the Clinical Efficacy of PowerHeal™ Bioelectric Bandage in Managing Infected Traumatic Wounds

Key Details

Gender

All

Age Range

18 Years - 105 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-02-11

Completion Date

2027-08

Last Updated

2026-03-06

Healthy Volunteers

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.

Inclusion Criteria: 1. Female and male participants 18-105 years of age 2. Hospital admission (or boarding in an emergency department or other area awaiting hospital admission) at participating clinical sites in Ukraine 3. 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: 1. Presence of worsening pain (from the moment of injury) 2. Erythema (redness) 3. Warmth (heat) 4. Edema (swelling) 5. Purulent exudate (drainage) 6. Delayed healing 7. Discoloration 8. Friable granulation 9. Foul odor 10. Wound margin breakdown or necrosis with or without fever 11. Pustules, vesicles, boils 4. Participant or legal representative provides written informed consent prior to investigation procedures 5. Participant understands and agrees to adhere to planned investigation procedures Exclusion Criteria: 1. Allergy to silver or zinc 2. Women who are pregnant or nursing 3. 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 4. 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 5. \> 60 days from the initial traumatic injury 6. Known prisoner 7. The patient is expected to be discharged from the hospital within the next 24 hours 8. Medical condition other than the acute traumatic wound (and its manifestations) that is likely to result in death within 14 days of randomization 9. Moribund condition, defined as life expectancy less than 48 hours from randomization 10. Patients undergoing comfort care measures only such that treatment focuses on end-of-life symptom management over prolongation of life 11. Expected inability or unwillingness to participate in study procedures 12. In the opinion of the investigator, participation in the investigation is not in the best interest of the patient Note: Allergies to parabens and acrylates will also be considered. While they are not direct exclusions, participants with these allergies should avoid being enrolled.

Locations (1)

Ivano-Frankivsk Central Clinical Hospital

Ivano-Frankivsk, Ukraine