Procellera® Compared to Standard of Care Treatment in Mitigating Biofilm Formation in Acute Trauma and Burn Wounds
Launched by THE METIS FOUNDATION · Sep 3, 2019
Trial Information
Current as of June 22, 2025
Completed
Keywords
ClinConnect Summary
The healing of traumatic wounds, to include burns, can be compromised by the presence of infection so efforts are made to prevent or diagnose infection early in order to mitigate the negative impact on healing. Electric stimulation has previously been shown to have both bacteriostatic and bactericidal effects in wounds. Until now, administering low intensity electric field/micro-current as a therapy to mitigate biofilm infection and to improve wound healing was not feasible. In this study the investigators will use Procellera® , a FDA approved fabric based wireless electroceutical dressing ...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 18-65 years of age
- • Willing and able to provide informed consent
- • Participant has acute partial-thickness or full-thickness wounds caused by trauma or partial-thickness burns that are ≥ 300 cm2 in size in one contiguous area or two separate wound sites ≥ 150 cm2 each
- Exclusion Criteria:
- • Pregnancy
- • Prisoner
- • Active malignancy or immunosuppressive therapy
- • Current systemic steroid use
- • Known allergy or sensitivity to silver or zinc
- * Participant's proposed study wound site has any of the following conditions:
- • Location is on the hands, face or feet
- • Full-thickness burn wounds
- • Exposure of visceral organs
- • Exposure of hardware or prosthetic exposure
About The Metis Foundation
The Metis Foundation is a dedicated clinical trial sponsor focused on advancing medical research and innovation to improve patient outcomes. With a commitment to ethical practices and scientific rigor, the Foundation collaborates with healthcare professionals, academic institutions, and industry partners to facilitate the development of novel therapies and interventions. By prioritizing patient safety and data integrity, the Metis Foundation aims to contribute to the growing body of knowledge in various medical fields and support the translation of research findings into effective clinical applications.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Fort Sam Houston, Texas, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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