Efficacy of Blue Light Therapy in Reducing Cutibacterium Acnes Bioburden at the Deltopectoral Interval
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of Participants With C. Acnes Bacterium Culture After Treatment
研究概览
简要总结
This proposal aims to investigate a novel light-based treatment to reduce morbidity in shoulder surgical patients. This has potential to improve outcomes and reduce health care utilization associated with infectious complications of shoulder arthroplasty. Participants will be healthy male volunteers at least 18 years of age. They will be on study for approximately 2 days.
详细描述
Participants will have two study visits (consent plus treatment and swabs for culture). These visits will be conducted at the main UW Hospital, UW Health at the American Center, or UW Health at 1 S. Park. All visits will be conducted in reserved conference rooms at each location.
Once a subject is determined to be eligible and has consented to the study, they will be randomized into one of three treatment groups. Study team has blank envelopes that contain one of the three treatment groups enclosed. After a subject consents to the study, the study team will randomly draw an envelope to assign a treatment arm.
Arm 1. One group will receive 5% topical benzoyl peroxide gel plus 2% chlorhexidine gluconate with 70% isopropyl alcohol
Arm 2. One group will receive blue light therapy plus 2% chlorhexidine gluconate with 70% isopropyl alcohol
Arm 3. One group will receive both of the above treatments
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male
- •18 years or older
排除标准
- •Allergy to benzoyl peroxide or chlorhexidine
- •<18 years of age
- •Previous history of shoulder infections
- •Antibiotics taken within one month of research visit
- •Immunocompromised state
- •Active cancer
- •Skin lesions or abrasions over the deltopectoral interval
- •Topical corticosteroid treatment to either shoulder or or systemic corticosteroid treatment within 2 weeks of research visit
- •Topical benzoyl peroxide treatment to either shoulder within 2 weeks of research visit
- •Blue light therapy treatment to either shoulder within 2 weeks of research visit
- •Prior incision over the deltopectoral interval of either shoulder
- •Contraindication to blue light treatment
研究组 & 干预措施
Blue Light Therapy
FDA cleared blue light product, Omniluxblue (Globalmed Technologies, Glen Elen, CA), which emits a 415 nm blue light irradiance of 40mW/cm2. Following the application of blue light protective eyewear, the blue light therapy device will be centered over the deltopectoral interval according to device standardized use instructions and a 23-minute treatment will be administered to dry skin. As was done in the topical BPO group, following treatment, a skin swab culture of the treatment shoulder will be taken, then both the treatment shoulder and control shoulder will be sterilely prepped with 2% chlorhexidine gluconate solution with 70% isopropyl alcohol and allowed to dry for 3 minutes. Following chlorhexidine preparation, a single set of cultures will be obtained from each shoulder. Participants and research personnel conducting the blue light treatments will be wearing medical grade blue light protective glasses for safety.
干预措施: Blue Light Therapy (Device)
5% Topical Benzoyl Peroxide Gel
A pea-sized amount, ~0.5 grams, will be applied to a 10cm strip over the deltopectoral interval beginning the morning 48 hours prior to schedule research visit to obtain cultures. The benzoyl peroxide will be applied on dry skin after a shower. The gel will be applied once in the morning and once in the evening for two consecutive days as well as the morning of the scheduled research visit. Following treatment, a skin swab culture of the treatment shoulder will be taken, both the treatment shoulder and control shoulder will be sterilely prepped with 2% chlorhexidine gluconate solution with 70% isopropyl alcohol and allowed to dry for 3 minutes. Following chlorhexidine preparation, a single set of cultures will be obtained from each shoulder.
干预措施: 5% Topical Benzoyl Peroxide Gel (Drug)
Light and Gel
Prior to treatment, a skin swab culture will be taken, 5% topical benzoyl peroxide treatment will be performed on dry skin immediately after a shower as described in the above paragraph. Again, five total treatments will be performed prior to research visit. On the day of the research visit, the blue light therapy protocol described above will be performed exactly the same followed by culture obtainment.
干预措施: 5% Topical Benzoyl Peroxide Gel (Drug)
Light and Gel
Prior to treatment, a skin swab culture will be taken, 5% topical benzoyl peroxide treatment will be performed on dry skin immediately after a shower as described in the above paragraph. Again, five total treatments will be performed prior to research visit. On the day of the research visit, the blue light therapy protocol described above will be performed exactly the same followed by culture obtainment.
干预措施: Blue Light Therapy (Device)
结局指标
主要结局
Number of Participants With C. Acnes Bacterium Culture After Treatment
时间窗: up to 2 days
Swab will be taken from skin and cultured for approximately 7 days to determine bacteria growth. This result is for the null condition following treatment with either blue light, blue light plus benzoyl peroxide or just benzoyl peroxide but before additional preparation with chlorhexidine.
Median Colony Forming Units (CFU) After Treatment
时间窗: up to 2 days
Quantitative culture analysis between treatment groups after treatment to the shoulder but before chlorhexidine preparation (null condition).
Percentage of Participants in Each Group With Positive C. Acnes Cultures
时间窗: up to 2 days
Comparison of positive Cutibacterium acnes cultures as a binary (yes/no) outcome between treatment arm and control arm following chlorhexidine (CHX) prep. Reported is the percentage of people in each group that had Cutibacterium acnes growth.
Median Colony Forming Units Per mL Treatment vs Control
时间窗: up to 2 days
Samples taken from treatment arm and control arm after chlorhexidine (CHX) preparation on both sides.
次要结局
未报告次要终点