Healing Electroceutical Dressing for the Recovery of Open Wounds (HERO)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-105
SponsorChandan Sen
About this trial
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
Qualifiers
Female and male participants 18-105 years of age
Hospital admission (or boarding in an emergency department or other area awaiting hospital admission) at participating clinical sites in Ukraine
Presence of worsening pain (from the moment of injury)
Erythema (redness)
Disqualifiers
Allergy to silver or zinc
Women who are pregnant or nursing
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
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
Trial design
Treatments tested in this trial
- PowerHeal™ Bioelectric Bandage
- Standard of care dressing
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Chandan Sen
Lead sponsor
University of Pittsburgh
Sponsor institution
University of Colorado, Denver
Collaborator
Source ClinicalTrials.gov