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NCT04079998 · ClinicalTrials.gov registry record · NA
Procellera® Compared to Standard of Care Treatment in Mitigating Biofilm Formation in Acute Trauma and Burn Wounds
A NA study of Trauma-related Wound and Burn, Partial Thickness, sponsored by The Metis Foundation.
- Completed
- Registry status
- NA
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT04079998: Completed NA study of Trauma-related Wound and Burn, Partial Thickness, sponsored by The Metis Foundation.
NCT04079998 is a NA study of Trauma-related Wound and Burn, Partial Thickness that has completed, run by The Metis Foundation. The registered enrollment target is 38 participants, above the 20-participant average among 3 other Trauma-related Wound trials with a reported enrollment target (90% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04079998, a NA study of Trauma-related Wound and Burn, Partial Thickness, has completed, sponsored by The Metis Foundation.
- COMPLETED
- Registry status
- NA
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of the study is to evaluate Procellera® , a novel FDA approved antimicrobial wound dressing in a prospective, randomized, controlled clinical study. The hypothesis is that when the dressing is moistened, the low electric field created by moisture-activated elemental silver and zinc electro-couple will prevent formation of biofilm in wounds or to disrupt existing biofilm.
Primary Outcome
Presence of biofilm will be assessed by obtaining a wound biopsy and analyzing with Scanning Electron Microscopy.
Conditions Studied
Interventions
- OTHER Standard of Care
- DEVICE Procellera®
Study Locations (1)
Texas
- Brooke Army Medical Center - Fort Sam Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2019-02-28 |
| Est. Completion | 2020-12-03 |
| Phase | NA |
What the finished NCT04079998 record still lists
NCT04079998 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, above the 20-participant average among 3 other Trauma-related Wound trials with a reported enrollment target (90% higher).
The record links to 2 conditions, with Trauma-related Wound appearing as the primary indexed condition, and to 2 interventions - of which Standard of Care is the first listed.
NCT04079998 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04079998 about?
NCT04079998 is a clinical study titled "Procellera® Compared to Standard of Care Treatment in Mitigating Biofilm Formation in Acute Trauma and Burn Wounds". The objective of the study is to evaluate Procellera® , a novel FDA approved antimicrobial wound dressing in a prospective, randomized, controlled clinical study. The hypothesis is that when the dressing is moistened, the low electric field created by moisture-activated elemental silver and zinc ele...
What is the current status of trial NCT04079998?
This trial is currently completed. It is a NA study. The enrollment target is 38 participants. The study started on 2019-02-28. Estimated completion is 2020-12-03.
What conditions does trial NCT04079998 study?
This clinical trial studies the following conditions: Trauma-related Wound, Burn, Partial Thickness.
What interventions are being tested in trial NCT04079998?
The interventions under investigation include: Standard of Care (OTHER), Procellera® (DEVICE).
Who is sponsoring clinical trial NCT04079998?
This trial is sponsored by The Metis Foundation, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04079998 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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