PowerHeal Bioelectric Bandage for infected open wound recovery
Prospective, Unblinded, Randomized, Controlled Investigation to Evaluate the Clinical Efficacy of PowerHeal™ Bioelectric Bandage in Managing Infected Traumatic Wounds
This tests whether the PowerHeal™ Bioelectric Bandage helps adults with infected traumatic wounds heal faster and clear infection better than standard dressings.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 105 Years |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Ivano-Frankivsk) |
| Trial ID | NCT07329114 on ClinicalTrials.gov |
What this trial studies
This randomized interventional trial in Ukraine enrolls hospitalized adults with infected traumatic wounds and compares a disposable wireless electroceutical dressing (PowerHeal™) to standard of care dressings over 28 ± 2 days. Participants are randomized into two groups with scheduled dressing changes, wound photography, and microbial swabs to track wound area and bacterial burden. Clinical data, wound size and appearance, and standard lab results will be recorded; no research blood draws are planned. The primary outcomes are wound closure by area measurement and control of wound infection by clinical assessment and microbiology.
Who should consider this trial
Good fit: Adults 18–105 years old hospitalized at participating Ukrainian sites with at least one probable or confirmed infected traumatic wound between 20–40 cm² and clinical signs of infection are ideal candidates.
Not a fit: People with wounds smaller than 20 cm², non-infected or chronic non‑traumatic wounds, or those not treated at participating sites are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the dressing could speed wound closure and reduce bacterial burden in infected traumatic wounds, potentially lowering complications and need for additional interventions.
How similar studies have performed: Electroceutical dressings and the PowerHeal™ device have demonstrated bactericidal and pro-healing effects in preclinical work and limited clinical use, but randomized data in complex traumatic wounds remain limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ivano-Frankivsk
- Ivano-Frankivsk Central Clinical Hospital — Ivano-Frankivsk, Ukraine (Recruiting)
Study contacts
- Principal investigator: Chandan K. Sen, PhD, MS — University of Pittsburgh
- Study coordinator: Shomita S Steiner, PhD, MS
- Email: SSTEINER@pitt.edu
- Phone: (463) 237-8770
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.