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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
PowerHeal™ Bioelectric Bandage
DevicePowerHeal™ 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.
Standard of care dressing
DeviceSOC 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.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Standard of Care (SOC) GroupActive comparator 1 intervention
Group B: SOC + PowerHeal™ Bioelectric Bandage GroupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
change in wound area
Assess the efficacy of WED in promoting wound closure. The digital photos taken at all visits will be quantitatively evaluated using ImageJ software that can measure the wound area. These measurements will be used for detailed analysis of wound closure over the period of study. Percentage decrease in wound area compared to SOC - from baseline (day 0) to final visit (day 28,± 2 days) will be calculated and analyzed, thus comparing range and rate of change between the two groups SOC and SOC + PowerHeal™ Bioelectric Bandage in aggregate. Adjustment for the correlated variance due to repeated measures will be made throughout the analysis. All analysis will be conducted at 0.05 level of significance.
Time frame
28 days (± 2 days)Secondary outcomes
1
Change in microbial population - types of strains and numbers of colonies
Assess the efficacy of PowerHeal™ Bioelectric Bandage in wound infection management. Swabs will be collected per standard local study guidelines. Clearance or presence of the numbers and types of clinically relevant microbes such as multidrug resistant (MDR) strains of ESKAPE pathogens (Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, Enterobacter spp.), Candida auris, and all Gram-negative isolates of clinical concern (e.g. Serratia sp., Citrobacter sp.) will be determined to evaluate the change in microbial load. Clinical assessments of wound infection will be calculated and compared across baseline, Day 7 (± 2 days), Day 14 (± 2 days) and end of study samples. The speciation provided by the laboratory conducting the analysis will determine changes in microbial pathogen over time. Adjustments will be made for variances due to repeated measures, and all analyses will be conducted at 0.05 level of significance.
Time frame
28 days (± 2 days)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Chandan Sen
Lead sponsor
University of Pittsburgh
Sponsor institution
University of Colorado, Denver
Collaborator
Source ClinicalTrials.gov