Healing Electroceutical Dressing for the Recovery of Open Wounds (HERO)
Trial Parameters
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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 Criteri