Safety and Tolerability Study of Antimicrobial TheraGauze for Skin Abscess

Completed · Phase 1/Phase 2

Conditions studied: Furunculosis

In brief

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.

Key facts

Study ID: NCT02334384
Run by: Eastern Virginia Medical School
People needed: 6
Starts: 2016-04-01
Expected to finish: 2017-08-30
Last updated by the study team: 2018-10-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Ages >18 to <65 years at time of enrollment
Subject has skin abscess requiring incision and drainage
Male or female
Ability to read and understand the English language at a level sufficient to provide informed consent and comply with study requirements
Subject is willing and able to comply with all study requirements

You may not qualify if…

Systemic illness or deep-seated infection requiring inpatient admission
Deep seated infection requiring referral to surgery
Subject requires oral antibiotics for suspicion of systemic spread of infection (i.e. bacteremia)
Allergy to any aminoglycoside antibiotic.
An underlying medical condition that impairs normal immune function (e.g. AIDS, cancer, diabetes, lupus, rheumatoid arthritis, organ or marrow transplantation, ulcerative colitis, Crohn's disease)
Subject is pregnant or breastfeeding and/or a woman of childbearing potential who is not surgically sterile, not at least 2 years postmenopausal, or does not practice contraception methods, unless sexually abstinent for the duration of the study.
Subject has any medical or psychiatric condition, in the opinion of the investigator, could jeopardize the subject's health or compromise the subject's ability to participate in the study.
Subject has prior treatment with antibiotics in the preceding 7 (seven) days.
Currently taking or has taken oral or injection steroid medication (e.g. prednisone) in the past 30 (thirty) days
Currently taking or has taken immune suppressing medications (e.g. methotrexate, Prograf, CellCept, Rapamune) in the past 30 (thirty) days
Currently taking or has taken medications to treat cancer in the past 30 (thirty) days
Subject is currently participating or has participated within the last two months in any study of an investigational drug or device.

Where it is running

Sentara Norfolk General Hospital — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.