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NCT02334384 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability Study of Antimicrobial TheraGauze for Skin Abscess
A Phase 1 study, sponsored by Eastern Virginia Medical School.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT02334384 is a Phase 1 study that has completed, run by Eastern Virginia Medical School. The registered enrollment target is 6 participants.
The verdict
NCT02334384, a Phase 1 study, has completed, sponsored by Eastern Virginia Medical School.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
The goal of this study is to demonstrate safety and tolerability of a novel antimicrobial wound dressing, Antimicrobial TheraGauze. The unique microvillous structure of TheraGauze is ideal for the development of an antimicrobial wound dressing. In vitro testing has demonstrated that tobramycin is an ideal compound for integration into TheraGauze providing excellent killing of MRSA and other organisms that commonly cause wound infections. Tobramycin is a non-absorbable aminoglycoside that will be contained solely to the wound bed preventing any potential for systemic toxicities. In vivo testing of tobramycin-impregnated TheraGauze used in mouse wound models has confirmed no systemic absorption of tobramycin as demonstrated by undetectable blood levels. TheraGauze has been commercially available for 10 years as a wound dressing. Tobramycin has been available for many years as a topical antibiotic as eyedrops and as an inhaled antibiotic for patients with cystic fibrosis, demonstrating excellent safety in both cases. This Phase I trial will test Antimicrobial TheraGauze (ATG) as an antimicrobial wound packing for patients presenting to an Emergency Department with skin abscess (furunculosis). Subjects will either receive ATG or standard of care wound packing (cotton wick or iodoform wick). Subjects will return to the ED in 2 days for wound packing removal and reassessment of their wounds and symptomatology. A final followup will be performed by a physician and study coordinator in an outpatient setting on day 7.
Interventions
- BIOLOGICAL Antimicrobial TheraGauze
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2016-04-01 |
| Est. Completion | 2017-08-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02334384
The ClinicalTrials.gov registry entry for NCT02334384 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eastern Virginia Medical School, which has 36 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Antimicrobial TheraGauze is the first listed.
NCT02334384 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02334384 about?
NCT02334384 is a clinical study titled "Safety and Tolerability Study of Antimicrobial TheraGauze for Skin Abscess". The goal of this study is to demonstrate safety and tolerability of a novel antimicrobial wound dressing, Antimicrobial TheraGauze. The unique microvillous structure of TheraGauze is ideal for the development of an antimicrobial wound dressing. In vitro testing has demonstrated that tobramycin is an...
What is the current status of trial NCT02334384?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2016-04-01. Estimated completion is 2017-08-30.
What interventions are being tested in trial NCT02334384?
The interventions under investigation include: Antimicrobial TheraGauze (BIOLOGICAL).
Who is sponsoring clinical trial NCT02334384?
This trial is sponsored by Eastern Virginia Medical School, which has 36 total clinical trials registered on ClinicalTrials.gov.
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