💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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