PowerHeal Bioelectric Bandage for infected open wound recovery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.