A Pilot Study to Evaluate Skin Swabbing with Chlorhexidine to Prevent Skin and Soft Tissue Infections Among People Who Inject Drugs

Phase 4

Completed

• Conditions: Opioid Use Disorder; Infection Control and Prevention; Injection Drug Use
• Interventions: Drug: Chlorhexidine gluconate; Drug: Isopropyl Alcohol 70% Topical Application Solution; Behavioral: Skin Prep Before Injecting Recreational/Street Drugs

• Registration Number: NCT06733506
• Lead Sponsor: Gabriel John Culbert

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2018-10-01
• Primary Completion: 2019-05-01
• Study Completion: 2019-05-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2024-12-10
• Last Update Submitted: 2024-12-10
• Study First Posted: 2024-12-13
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Self-report intravenous drug use within past 30 days

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Chlorhexidine Swabs	Chlorhexidine gluconate	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.
Chlorhexidine Swabs	Skin Prep Before Injecting Recreational/Street Drugs	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.
Usual Care	Isopropyl Alcohol 70% Topical Application Solution	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.
Usual Care	Skin Prep Before Injecting Recreational/Street Drugs	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.

Primary Outcome Measures

Name	Time	Method
Skin swabbing frequency	2 weeks after randomization	How often do you clean the skin where you will inject before you inject (past 30 days)? (never, rarely, occasionally, sometimes, frequently, usually, always)

Secondary Outcome Measures

Name	Time	Method
Swab acceptability	2 weeks after randomization	9-items measure swab acceptability, convenience, safety, ease of use, usefulness, tolerability, satisfaction, and self-efficacy
Safer injection knowledge and behaviors	2 weeks after randomization	7-items measure participant knowledge, motivation, and behaviors about skin swabbing to prevent skin and soft tissue infections.

Trial Locations

Locations (1)

University of Illinois Chicago; 🇺🇸 Chicago, Illinois, United States