Photodynamic Therapy for Cutibacterium Acnes (C. Acnes) Decolonization of the Shoulder Dermis
试验速览
- 阶段
- 3 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in the number of patients who have microbiological results positive for the bacteria C. acnes after treatment with 5-aminolevulinic acid-photodynamic therapy (ALA-PDT) versus those who were not.
研究概览
简要总结
This is a prospective, randomized controlled trial to evaluation the ability of 5-aminolevulinic acid HCL topical solution photodynamic therapy to decrease the colonization of Cutibacterium acnes (C. acnes- a bacteria commonly found in the dermis of the skin surrounding the shoulder) in order to decrease postoperative joint infections.
-Aminolevulinic acid (ALA) is a naturally occurring metabolite in the synthesis of pathway of cellular heme production. Adding ALA to bacteria encourages porphyrin production which serve as the immediate precursors to heme production. When these porphyrins are illuminated with blue light at an emission peak of 407-420nm, these metabolites become exothermic and cause internal destruction of the bacterial cells. This therapy does not cause any damage to the mammalian cells, which makes PDT safe for human skin treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •All male patients (>18) undergoing shoulder arthroscopy)
排除标准
- •Female patients
- •Patients with active acnes
- •Patients who have taken antibiotics within a month of their surgery
- •Subjects with psoriatic/eczematous lesions on the shoulder girdle
- •Patients on anticoagulant therapy
- •Patients who have a known allergy to any of the agents used in the study protocol
研究组 & 干预措施
Group 1: Phototherapy Group
patient will be instructed to apply 5-aminolevulinic acid HCL topical solution to their shoulder prior to their surgery. 16 minutes before skin incision a blue light will be applied to the area of the shoulder where the 5-ALA was administered
干预措施: Skin Biopsy (Procedure)
Group 1: Phototherapy Group
patient will be instructed to apply 5-aminolevulinic acid HCL topical solution to their shoulder prior to their surgery. 16 minutes before skin incision a blue light will be applied to the area of the shoulder where the 5-ALA was administered
干预措施: 5 Aminolevulinic Acid + Phototherapy (Drug)
Group 2: Control Group
patient will undergo standard of care surgery
干预措施: Skin Biopsy (Procedure)
结局指标
主要结局
Change in the number of patients who have microbiological results positive for the bacteria C. acnes after treatment with 5-aminolevulinic acid-photodynamic therapy (ALA-PDT) versus those who were not.
时间窗: 13 days
次要结局
- Decrease Rate of Postoperative Infection(3 months)