Safety and Tolerability Study of Antimicrobial TheraGauze for Skin Abscess
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Number of Side-effects
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Antimicrobial TheraGauze (Biological)
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.
结局指标
主要结局
Number of Side-effects
时间窗: 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.
次要结局
未报告次要终点
研究者
Kenji Cunnion
Associate Professor
Eastern Virginia Medical School