Clinical Trial: Safety and Tolerability Study of Antimicrobial TheraGauze for Skin Abscess

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Safety and Tolerability Study of Antimicrobial TheraGauze for Skin Abscess

Brief 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.

Detailed Summary:

Primary Endpoint. The primary endpoint of the study is to evaluate the safety of and identify side effects of TheraGauze/tobramycin wound packing compared with standard of care management for cutaneous abscesses requiring incision and drainage.

Methods.

Design:

This is a proof-of-concept, prospective, randomized clinical trial for safety of TheraGauze-tobramycin in adult subjects who present to Emergency Department settings for care of skin abscess requiring incision and drainage. A control, standard of care, arm is included to provide some data with respect to the side effect profile of current furunculosis management for comparison.

Two arms are proposed for this study:

1. Incision + TheraGauze+tobramycin packing (no systemic antibiotics)

2. Incision + standard iodoform wick or plain cotton wick packing (± p.o. antibiotics)

   Anti-microbial TheraGauze (saturated tobramycin solution at 3 mg/ml) will be packed into the drained wounds of the subjects in the study arm. The control arm will receive current standard of care wound packing with a choice of iodoform wick or plain cotton wick, based on the preference of the ED physician. After packing, the wound excess TheraGauze or wick will be cut away. The ED physicians have the option to prescribe an oral antibiotic or not, according to their preference. The following oral antibiotic choices are available for subjects in the control arm only:

   • Bactrim (TMP/SMX)
   • 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.