Safety and Tolerability Study of Antimicrobial TheraGauze for Skin Abscess

NCT02334384 | Completed Phase 1 Results

• 1 other identifier: SS-ATG-001
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Furunculosis

Outcome Measures

Primary Outcomes (1)

• Number of Side-effects

  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.

  1 week

Study Arms (2)

Antimicrobial TheraGauze

EXPERIMENTAL

Antimicrobial TheraGauze (i.e. tobramycin impregnated TheraGauze) will be used as a wound packing after incision and drainage of skin abscess (i.e. furunculosis). Antimicrobial TheraGauze will be administered once.

Biological: Antimicrobial TheraGauze

Standard of care - standard wound packing

NO INTERVENTION

In this control arm the subject will receive standard of care with standard wound packing. The ED physician will have the choice to use plain cotton wick or iodoform wick. Standard wound packing will be administered once.

Interventions

Antimicrobial TheraGauze BIOLOGICAL

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.

Antimicrobial TheraGauze

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Eastern Virginia Medical School: lead
• Solsys Medical LLC: collaborator
• United States Department of Defense: collaborator

Study Sites (1)

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Furunculosis

Condition Hierarchy (Ancestors)

Staphylococcal Skin Infections; Staphylococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Bacterial; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Fish Diseases; Animal Diseases

Results Point of Contact

• Title: Kenji Cunnion
• Organization: Eastern Virginia Medical School

cunniokm@evms.edu

7574465125

Study Officials

• Kenji M Cunnion, M.D., M.P.H.

  Eastern Virginia Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 5, 2015
• First Posted: January 8, 2015
• Study Start: April 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 30, 2017
• Last Updated: October 4, 2018
• Results First Posted: August 29, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)