NCT07329114 Healing Electroceutical Dressing for the Recovery of Open Wounds (HERO)
| NCT ID | NCT07329114 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chandan Sen |
| Condition | Wound Heal |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-02-11 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2026-02-11 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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.
Eligibility Criteria
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.
Contact & Investigator
Chandan K. Sen, PhD, MS
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT07329114 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 105 Years, studying Wound Heal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07329114 currently recruiting?
Yes, NCT07329114 is actively recruiting participants. Contact the research team at SSTEINER@pitt.edu for enrollment information.
Where is the NCT07329114 trial being conducted?
This trial is being conducted at Ivano-Frankivsk, Ukraine.
Who is sponsoring the NCT07329114 clinical trial?
NCT07329114 is sponsored by Chandan Sen. The principal investigator is Chandan K. Sen, PhD, MS at University of Pittsburgh. The trial plans to enroll 150 participants.