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New treatment option for Wound Heal
Official title Healing Electroceutical Dressing for the Recovery of Open Wounds (HERO)
ClinicalTrials.gov ID: NCT07329114
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 105
You may be able to join if
- 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
- 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...
- Presence of worsening pain (from the moment of injury)
- Erythema (redness)
You likely can't join if
- 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...
- Sponsor or contract research organization (CRO) staff directly involved in the conduct of the investigation, and site staff supervised by the...
- \> 60 days from the initial traumatic injury
- Known prisoner
See the full eligibility criteria
- 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
- 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...
- Presence of worsening pain (from the moment of injury)
- Erythema (redness)
- Warmth (heat)
- Edema (swelling)
- Purulent exudate (drainage)
- Delayed healing
- Discoloration
- Friable granulation
- Foul odor
- Wound margin breakdown or necrosis with or without fever
- Pustules, vesicles, boils
- Participant or legal representative provides written informed consent prior to investigation procedures
- Participant understands and agrees to adhere to planned investigation procedures
- 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
- \> 60 days from the initial traumatic injury
- Known prisoner
- The patient is expected to be discharged from the hospital within the next 24 hours
- Medical condition other than the acute traumatic wound (and its manifestations) that is likely to result in death within 14 days of randomization
- Moribund condition, defined as life expectancy less than 48 hours from randomization
- Patients undergoing comfort care measures only such that treatment focuses on end-of-life symptom management over prolongation of life
- Expected inability or unwillingness to participate in study procedures
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Ivano-Frankivsk, Ukraine
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 105 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ivano-Frankivsk, Ukraine. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.