Randomized, Exploratory Study to Evaluate Changes to Skin Microbiome With Tape-stripped Wounds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Microbial Community Richness - Baseline (Day 0)
研究概览
简要总结
This single center, randomized, 15-day clinical trial is being conducted to assess the changes to the skin microbiome of induced wounds on the back in approximately 35 healthy adult subjects aged 18-55 years, with Fitzpatrick Skin Types I - III. Microbiome and skin physiology assessments will be completed.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 to 55 years of age.
- •Fitzpatrick skin types I to III.
- •Must be able to comprehend and follow the requirements of the study
- •Avoid excessive sun exposure
- •Willing to refrain from topical product use on the back for the duration of the study.
- •Subjects must agree not to immerse their bandages in water for the duration of the study.
- •Male and female subjects with reproductive potential who agree to practice a medically acceptable form of birth control
排除标准
- •Excessively hairy back, acne, scars and pigmentation or nevi t
- •. Pregnant or Lactating, or planning on becoming pregnant;
- •. Known allergies or sensitivities to anesthetics, adhesive bandages, wound treatment products or tapes;
- •. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results
- •Participation in any other clinical study within 30 days of Visit 1;
- •. Subjects who have a health condition and/or pre-existing or dormant dermatologic conditions or who have clinically active bacterial, fungal, or viral skin infections or those who are susceptible to cutaneous infections
- •Subjects who report using prescription or OTC medication (oral or topical) that can make skin more sensitive or influence the skin (i.e. antibiotics, hormones, insulin, etc.)
- •Subjects receiving topical and/or inhaled medications that may alter or compromise the bleeding/healing process
- •Individuals with a history of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications and/or radiation
- •. Subjects with a known history of keloid or hypertrophic scar formation;
- •Subjects diagnosed with any blood clotting disorder;
- •Hyperthyroidism or hypothyroidism or with active or recently treated (within 1 year) skin cancer, or those in poor nutritional status; 13 Subjects taking oral Vitamin A derivatives such as Accutane, isotretinon, or using retinoic acid in the past 1 year or using topical Vitamin A derivatives in the 3 weeks prior to study start;
- •Subjects with clinically infected skin lesions;
- •Subjects with cracked or excoriated skin, or other skin problems.
- •Diabetes mellitus that cannot be controlled by diet alone (i.e. requires systemic medications for control);
- •Subjects with friable skin, at the discretion of the Investigator;
研究组 & 干预措施
ADHESIVE BANDAGE #1
bandage applied to wounded site.
干预措施: ADHESIVE BANDAGE #1 (Device)
ADHESIVE BANDAGE #2
bandage applied to wounded site.
干预措施: ADHESIVE BANDAGE #2 (Device)
ADHESIVE BANDAGE #3
bandage applied to wounded site
干预措施: ADHESIVE BANDAGE #3 (Device)
Antibacterial Bandage with 0.8% BZK
bandage with 0.8% Benzalkonium Chloride (BZK) applied to wounded site
干预措施: Antibacterial Bandage with 0.8% BZK (Device)
Intact and No Bandage
This test site will remain intact (not wounded) and not treated with a bandage, serving as a negative control site.
干预措施: Intact and No Bandage (Other)
Wounded and No Bandage
This test site will be wounded and no bandage applied, serving as a positive control site.
干预措施: Wounded and No Bandage (Other)
结局指标
主要结局
Microbial Community Richness - Baseline (Day 0)
时间窗: Baseline (Day 0)
Swabs will be collected on the back at Baseline (Day 0) and analyzed to determine the total number of different bacterial taxa (microorganisms) detected in the sample. There was no prespecified primary endpoint in the protocol.
Microbial Community Richness - (Day 3)
时间窗: Day 3
Swabs will be collected on the back at Day 3 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.
Microbial Community Richness - (Day 5)
时间窗: Day 5
Swabs will be collected on the back at Day 5 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.
Microbial Community Diversity - Day 3
时间窗: Day 3
Swabs will be collected on the back at Day 3 for analysis based on the Shannon Index.
Microbial Community Richness - (Day 1)
时间窗: Day 1
Swabs will be collected on the back at Day 1 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.
Microbial Community Richness - (Day 2)
时间窗: Day 2
Swabs will be collected on the back at Day 2 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.
Microbial Community Richness - (Day 4)
时间窗: Day 4
Swabs will be collected on the back at Day 4 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.
Microbial Community Richness - (Day 7)
时间窗: Day 7
Swabs will be collected on the back at Day 7 and analyzed to determine the total number of different bacteria Taxa (microorganismss) detected in the sample.
Microbial Community Richness - (Day 14)
时间窗: Day 14
Swabs will be collected on the back at Day 14 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.
Microbial Community Diversity - Baseline (Day 0)
时间窗: Baseline (Day 0)
Swabs will be collected on the back at Baseline (Day 0) for analysis based on the Shannon Index.
Microbial Community Diversity - Day 1
时间窗: Day 1
Swabs will be collected on the back at Day 1 for analysis based on the Shannon Index.
Microbial Community Diversity - Day 2
时间窗: Day 2
Swabs will be collected on the back at Day 2 for analysis based on the Shannon Index.
Microbial Community Evenness - Day 1
时间窗: Day 1
Swabs will be collected on the back at Day 1 for analysis based on the Pielou's Evenness Index.
Microbial Community Richness - (Day 6)
时间窗: Day 6
Swabs will be collected on the back at Day 6 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.
Microbial Community Diversity - Day 4
时间窗: Day 4
Swabs will be collected on the back at Day 4 for analysis based on the Shannon Index.
Microbial Community Diversity - Day 7
时间窗: Day 7
Swabs will be collected on the back at Day 7 for analysis based on the Shannon Index.
Microbial Community Evenness - Day 2
时间窗: Day 2
Swabs will be collected on the back at Day 2 for analysis based on the Pielou's Evenness Index.
Microbial Community Evenness - Day 3
时间窗: Day 3
Swabs will be collected on the back at Day 3 for analysis based on the Pielou's Evenness Index.
Microbial Community Evenness - Day 4
时间窗: Day 4
Swabs will be collected on the back at Day 4 for analysis based on the Pielou's Evenness Index.
Microbial Community Diversity - Day 5
时间窗: Day 5
Swabs will be collected on the back at Day 5 for analysis based on the Shannon Index.
Microbial Community Diversity - Day 6
时间窗: Day 6
Swabs will be collected on the back at Day 6 for analysis based on the Shannon Index.
Microbial Community Evenness - Baseline (Day 0)
时间窗: Day 0
Swabs will be collected on the back at Baseline (Day 0) for analysis based on the Pielou's Evenness Index.
Microbial Community Evenness - Day 7
时间窗: Day 7
Swabs will be collected on the back at Day 7 for analysis based on the Pielou's Evenness Index.
Microbial Community Diversity - Day 14
时间窗: Day 14
Swabs will be collected on the back at Day 14 for analysis based on the Shannon Index.
Microbial Community Evenness - Day 5
时间窗: Day 5
Swabs will be collected on the back at Day 5 for analysis based on the Pielou's Evenness Index.
Microbial Community Evenness - Day 6
时间窗: Day 6
Swabs will be collected on the back at Day 6 for analysis based on the Pielou's Evenness Index.
Microbial Community Evenness - Day 14
时间窗: Day 14
Swabs will be collected on the back at Day 14 for analysis based on the Pielou's Evenness Index.
次要结局
- Redness: Wound Area Oxyhemoglobin Level - Day 2(Day 2)
- Skin Barrier Function -Baseline (Day 0)(Day 0)
- Skin Barrier Function - Day 1(Day 1)
- Skin Barrier Function - Day 2(Day 2)
- Skin Barrier Function - Day 3(Day 3)
- Skin Barrier Function - Day 4(Day 4)
- Skin Barrier Function - Day 5(Day 5)
- Skin Barrier Function - Day 7(Day 7)
- Redness: Wound Area Oxyhemoglobin Level- Baseline (Day 0)(Day 0)
- Redness: Wound Area Oxyhemoglobin Level - Day 1(Day 1)
- Skin Barrier Function - Day 6(Day 6)
- Skin Barrier Function - Day 14(Day 14)
- Redness: Wound Area Oxyhemoglobin Level - Day 3(Day 3)
- Redness: Wound Area Oxyhemoglobin Level - Day 5(Day 5)
- Redness: Wound Area Oxyhemoglobin Level - Day 7(Day 7)
- Redness: Wound Area Oxyhemoglobin Level - Day 14(Day 14)
- Redness: Wound Area Oxyhemoglobin Level - Day 4(Day 4)
- Redness: Wound Area Oxyhemoglobin Level - Day 6(Day 6)