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Trial record 17 of 11559 for:    Anti-Infective Agents AND antibacterial

Safety and Tolerability Study of Antimicrobial TheraGauze for Skin Abscess

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ClinicalTrials.gov Identifier: NCT02334384
Recruitment Status : Completed
First Posted : January 8, 2015
Results First Posted : August 29, 2018
Last Update Posted : October 4, 2018
Sponsor:
Collaborators:
Solsys Medical LLC
United States Department of Defense
Information provided by (Responsible Party):
Kenji Cunnion, Eastern Virginia Medical School

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.


Condition or disease Intervention/treatment Phase
Furunculosis Biological: Antimicrobial TheraGauze Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Tolerability Study of Antimicrobial TheraGauze for Skin Abscess
Actual Study Start Date : April 1, 2016
Actual Primary Completion Date : August 1, 2017
Actual Study Completion Date : August 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Antimicrobial TheraGauze
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

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.


No Intervention: Standard of care - standard wound packing
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.



Primary Outcome Measures :
  1. Number of Side-effects [ Time Frame: 1 week ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02334384


Locations
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United States, Virginia
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Eastern Virginia Medical School
Solsys Medical LLC
United States Department of Defense
Investigators
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Principal Investigator: Kenji M Cunnion, M.D., M.P.H. Eastern Virginia Medical School
  Study Documents (Full-Text)

Documents provided by Kenji Cunnion, Eastern Virginia Medical School:

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Responsible Party: Kenji Cunnion, Associate Professor, Eastern Virginia Medical School
ClinicalTrials.gov Identifier: NCT02334384     History of Changes
Other Study ID Numbers: SS-ATG-001
First Posted: January 8, 2015    Key Record Dates
Results First Posted: August 29, 2018
Last Update Posted: October 4, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Anti-Infective Agents
Anti-Bacterial Agents
Furunculosis
Staphylococcal Skin Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Skin Diseases, Bacterial
Skin Diseases, Infectious
Infection
Skin Diseases