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Search / Trial NCT04079998

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.

Locations

Fort Sam Houston, Texas, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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