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临床试验/NCT06733506
NCT06733506已完成4 期

A Pilot Study to Evaluate the Acceptability and Feasibility of Skin Swabbing With Chlorhexidine Gluconate to Prevent Skin And Soft Tissue Infections Among People Who Inject Drugs

Gabriel John Culbert1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2018年10月1日最近更新:
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
56
试验地点
1
主要终点
Frequency of Skin Swabbing

研究概览

简要总结

The study examined chlorhexidine gluconate (CHG) swabs as a skin disinfectant in combination with a single-session safer injection training to prevent skin and soft tissue infections (SSTI) in people who inject drugs.

详细描述

Skin and soft tissue infections (SSTI) are a serious and preventable complication of intravenous drug use, yet few interventions have been developed to reduce SSTI in people who inject drugs (PWID). This study tested two interventions to reduce SSTI in PWID: 1) a single-session behavioral intervention to inculcate skin swabbing behaviors, and 2) chlorhexidine swabs to be used as for cleaning the skin prior to injecting.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Single (Outcomes Assessor)

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

  • Self-report intravenous drug use within past 30 days

排除标准

  • 未提供

研究组 & 干预措施

Chlorhexidine Swabs

Experimental

Participants randomized to the experimental condition received a 2-week supply of chlorhexidine gluconate pre-saturated, single-use swabs that they were instructed to use for cleaning their skin prior to injecting for the next 2 weeks.

干预措施: Chlorhexidine gluconate (Drug)

Chlorhexidine Swabs

Experimental

Participants randomized to the experimental condition received a 2-week supply of chlorhexidine gluconate pre-saturated, single-use swabs that they were instructed to use for cleaning their skin prior to injecting for the next 2 weeks.

干预措施: Skin Prep Before Injecting Recreational/Street Drugs (Behavioral)

Usual Care

Active Comparator

Participants randomized to a usual care condition received a 2-week supply of isopropyl alcohol swabs that that they were instructed to use for the next 2 weeks to clean their skin prior to injecting.

干预措施: Isopropyl Alcohol 70% Topical Application Solution (Drug)

Usual Care

Active Comparator

Participants randomized to a usual care condition received a 2-week supply of isopropyl alcohol swabs that that they were instructed to use for the next 2 weeks to clean their skin prior to injecting.

干预措施: Skin Prep Before Injecting Recreational/Street Drugs (Behavioral)

结局指标

主要结局

Frequency of Skin Swabbing

时间窗: 2 weeks after randomization

This question asks how often participants use isopropyl alcohol or chlorhexidine gluconate swabs to disinfect their skin before injecting drugs (never, rarely, occasionally, sometimes, frequently, usually, always)

次要结局

  • Swab Acceptability Rating(2 weeks after randomization)
  • Safer Injection Knowledge and Behaviors(2 weeks after randomization)

研究者

发起方
Gabriel John Culbert
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gabriel John Culbert

Associate Professor

University of Illinois at Chicago

研究点 (1)

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