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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: Completed Phase 1 study, sponsored by Eastern Virginia Medical School.
NCT02334384 is a Phase 1 study that has completed, run by Eastern Virginia Medical School. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Evaluate for evidence of side-effects from Antimicrobial TheraGauze packing of skin abscess wounds compared with standard of care (i.e. cotton wick or iodoform wick). Tests for statistical significance will be made for multiple potential side-effects including: 1) erythema around the wound packing, 2) increased pain at the wound site, 3) increased tenderness around the wound 4) increased discharge from the wound, 4) new rash, and 5) fever.
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 |
What the finished NCT02334384 record still lists
NCT02334384 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which Antimicrobial TheraGauze is the first listed.
NCT02334384 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02334384's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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