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Safety and Tolerability Study of Antimicrobial TheraGauze for Skin Abscess

NCT02334384 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2018-10-04

Study results available
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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.

Conditions

  • Furunculosis

Interventions

BIOLOGICAL

Antimicrobial TheraGauze

In the intervention arm: Antimicrobial TheraGauze, tobramycin impregnated TheraGauze, will be used to pack the wound cavity after incision and drainage of the skin abscess. In the comparator arm: Standard wound packing, plain cotton wick or iodoform gauze - at the discretion of the provider will be used to pack the wound cavity after incision and drainage of the skin abscess.

Sponsors & Collaborators

  • Solsys Medical LLC

    collaborator INDUSTRY

  • United States Department of Defense

    collaborator FED

  • Eastern Virginia Medical School

    lead OTHER

Principal Investigators

  • Kenji M Cunnion, M.D., M.P.H. · Eastern Virginia Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-01
Primary Completion
2017-08-01
Completion
2017-08-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02334384 on ClinicalTrials.gov