Antimicrobial Activity of IV Clear™ Dressing - Prevention of Antimicrobial Regrowth
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Change in skin microbial colonization over 7-day period of antimicrobial dressing application
研究概览
简要总结
The purpose of this study is to assess the surface cutaneous antimicrobial activity of IV Clear™ Dressing, Tegaderm CHG™ Dressing and a Silicone Vehicle Control Dressing.
详细描述
A single center, within-subject randomized study design in healthy adult subjects with a history of high bacteria counts on their upper back, meeting the inclusion criteria.
Antimicrobial efficacy will be measured by determining the mean number of Colony Forming Units (CFUs) per square centimetre (cm²) of skin prior to treatment (baseline measurement), following preparation with 70% isopropyl alcohol, and following post treatment samples.
The goal of this study is to demonstrate that IV Clear™ is as effective as or better than Tegaderm™ CHG dressing in preventing regrowth of cutaneous microbial flora on test subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- 是
入选标准
- •Are ≥ 18 years of age and ≤ 65 years of age
- •Are in good health, as evidenced by response to the demographics/dermatological medical history form
- •Are willing to refrain from using antimicrobial soaps for bathing and showering during the entire study
- •Are willing to refrain from swimming in chemically treated pool or hot tub for duration of study
- •Are willing to refrain from using antimicrobial/medicated lotions and creams for duration of study, unless prescribed by a physician for an intercurrent illness
- •Are willing to refrain from using topical or systemic antibiotic medication for duration of study, unless prescribed by a physician for an intercurrent illness
- •Are willing to refrain from use of body powders and fabric softeners
- •Are willing to use soap and shampoo and antiperspirant/deodorant provided exclusively during study
- •Have qualification screening bacterial counts of ≥ 2.5 log10 CFU/cm² on two contralateral sites on the upper back
- •Are willing to comply with all study protocol requirements
排除标准
- •Subjects will not be enrolled in the study if they:
- •Are currently pregnant or lactating
- •Have been exposed to topical or systemic antimicrobials during two weeks proceeding treatment. This restriction will include, but is not limited to shampoos, lotions, soaps, body powders, and materials such as solvents, acids, or alkalis
- •Have known soap, detergent, antibiotic and/or perfume allergies
- •Have been medically diagnosed as having a medical condition that precludes participation, such as: diabetes, hepatitis, an organ transplant, a medical surgical implant or an immune compromised system
- •Have any medical condition which in the opinion of the Investigator prelude participation
- •Have swam in chemically treated pools or hot tubs two weeks prior to any microbial sampling
- •Have used UV tanning lamps two weeks prior to any microbial sampling
- •Have tattoos, dermatoses, abrasions, cuts, lesions or other skin disorders on test sites
- •Have bathed or showered less than 48 hours prior to any microbial sampling
- •Have known sensitivity to adhesive products, or to materials used in test articles
- •Have participated in any type of back wash study within 7 days prior to study
- •Have a known sensitivity to latex products
- •Are not willing to fulfill the requirements of the protocol
结局指标
主要结局
Change in skin microbial colonization over 7-day period of antimicrobial dressing application
时间窗: Assessed after 4 days and 7 days of dressing application
Mean number of Colony Forming Units (CFUs) per square centimetre (cm²) of skin prior to treatment (baseline), following prepping with 70% isopropyl alcohol and following post treatment samplings of IV Clear™, Tegaderm™ CHG and Silicone control dressings collected.
次要结局
未报告次要终点