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临床试验/NCT03257202
NCT03257202已完成2 期

Cutibacterium Acnes Persists Despite Topical Clindamycin and Benzoyl Peroxide

University of Southern California1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2017年9月11日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
12
试验地点
1
主要终点
Number of Subjects With Positive Bacterial Growth Culture Per Treatment Arms

研究概览

简要总结

This study is about preventing surgical site infections of the shoulder. We hope to learn if clindamycin alone, benzoyl peroxide alone, or clindamycin and benzoyl peroxide together can affect growth of Propionibacterium acnes in the dermal layer.

详细描述

P. acnes are skin pathogens known to cause surgical site infections despite proper preoperative surgical preparation. Lee et al. showed 70% growth rate of P. acnes despite the application of Choraprep prior to sampling. However, this study was limited as it failed to utilize a control group and only investigated one preparatory technique. Meanwhile, there remains to date no study investigating the effect of topical treatments. The purpose of this study is to investigate how specific topical treatments affect growth in the dermal layer. 12 volunteers who are normal volunteers, students, or employees of USC will each receive 4 punch biopsies from their back above the scapular spine, with each biopsy taken from a region of the skin treated with a different topical (topical clindamycin alone, topical benzoyl peroxide alone, topical clindamycin and benzoyl peroxide together, and a control). A 3df overall test of the treatment indicators will test for any differences in positivity for P Acnes among the treatments; pairwise comparisons among the treatments will adjust for multiple comparisons. A two-tailed statistical test will be performed, testing at an alpha of 0.05, and analyses will also be performed based on hemolytic subtypes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • healthy volunteer
  • age > 18

排除标准

  • history of antibiotic use in the last month
  • active acne on the back
  • non-English speakers (the study personnel do not have adequate training to converse and consent in other languages)

研究组 & 干预措施

Clindamycin alone

Experimental

topical clindamycin alone using Clindamycin 1% Gel

干预措施: Clindamycin 1% Gel (Drug)

Benzoyl peroxide alone

Experimental

topical benzoyl peroxide alone using Benzoyl Peroxide 5% Gel

干预措施: Benzoyl peroxide 5% gel (Drug)

Clindamycin and benzoyl peroxide

Experimental

Topical clindamycin and topical benzoyl peroxide together using BenzaClin 5%-1% Topical Gel

干预措施: BenzaClin 5%-1% Topical Gel (Drug)

结局指标

主要结局

Number of Subjects With Positive Bacterial Growth Culture Per Treatment Arms

时间窗: 21 days

Detected presence of growth of Propionibacterium acnes on bacterial culture (bacteria per mL) by treatment arms.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

George F. Hatch

Principal Investigator

University of Southern California

研究点 (1)

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