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COMPLETED NA

Procellera® Compared to Standard of Care Treatment in Mitigating Biofilm Formation in Acute Trauma and Burn Wounds

NCT04079998 · View on ClinicalTrials.gov ↗

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.

Interventions

  • OTHER Standard of Care
  • DEVICE Procellera®

Study Locations (1)

Texas

  • Brooke Army Medical Center — Fort Sam Houston

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2019-02-28
Est. Completion 2020-12-03
Phase NA

Sponsor

The Metis Foundation

7 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04079998

The ClinicalTrials.gov registry entry for NCT04079998 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Metis Foundation, which has 7 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04079998 reports 1 study location spanning 1 distinct geographic area — top geographies include Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04079998?

The interventions under investigation include: Standard of Care (OTHER), Procellera® (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04079998?

This trial is sponsored by The Metis Foundation, which has 7 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial