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

NCT06733506 | Completed Phase 4 FDA Drug

• 1 other identifier: 2018-0488
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use Disorder; Injection Drug Use; Skin and Soft Tissue Infections (SSTIs)

Keywords

opioid use disorder; injection drug use; skin and soft tissue infection; chlorhexidine; people who inject drugs

Outcome Measures

Primary Outcomes (1)

• Frequency of Skin Swabbing

  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)

  2 weeks after randomization

Secondary Outcomes (2)

• Swab Acceptability Rating

  2 weeks after randomization

• Safer Injection Knowledge and Behaviors

  2 weeks after randomization

Other Outcomes (1)

• Skin and Soft Tissue Infection Rate

  2 weeks after randomization

Study Arms (2)

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.

Drug: Chlorhexidine gluconate; Behavioral: Skin Prep Before Injecting Recreational/Street Drugs

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.

Drug: Isopropyl Alcohol 70% Topical Application Solution; Behavioral: Skin Prep Before Injecting Recreational/Street Drugs

Interventions

Chlorhexidine gluconate DRUG

Chlorhexidine gluconate (CHG) is a cationic bisguanide that works through disruption of cell membranes. CHG has broad spectrum activity against gram-positive bacteria and to a lesser extent gram negative bacteria. CHG has significant residual activity and addition of alcohol based preparations results in even greater residual activity compared to alcohol alone. CHG acts in the presence of organic material (e.g., blood and biofilm) and its antimicrobial activity is slower than that of alcohols. Prevantics® 1 ml Swab contains a cutaneous solution of 3.15% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), which is commonly used for the preparation of a patient's skin prior to surgery or venipuncture. Prevantics® Swab is available as a single use pre-moistened 2-sided applicator (1.0 ml).

Chlorhexidine Swabs

Isopropyl Alcohol 70% Topical Application Solution DRUG

Isopropyl alcohol (IPA), a topical skin disinfectant, is effective against many pathogens and is commonly supplied as 2x2 inch pre-soaked, single-use gauze wipes.

Usual Care

Skin Prep Before Injecting Recreational/Street Drugs BEHAVIORAL

During a single 10 minute session, a healthcare provider gives the participant verbal and written information, counseling, and training to reinforce participant knowledge, motivation, and skills to practice skin swabbing correctly and routinely before injecting.

Chlorhexidine Swabs; Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-report intravenous drug use within past 30 days

You may not qualify if:

• None

Sponsors & Collaborators

• Gabriel John Culbert: lead

Study Sites (1)

University of Illinois Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Soft Tissue Infections

Interventions

chlorhexidine gluconate; 2-Propanol; Illicit Drugs

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Infections

Intervention Hierarchy (Ancestors)

Propanols; Alcohols; Organic Chemicals; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: All participants received a brief safer-injection training (Intervention A), which consisted of a one-to-one private discussion with a healthcare provider lasting \~5-10 minutes to encourage skin swabbing prior to drug injection. In addition, participants randomized to a Chlorhexidine swab group received a 2-week supply of chlorhexidine swabs which they were instructed to use for 2 weeks, while those randomized to a usual care condition were supplied with a 2-week supply of standard care isopropyl alcohol swabs.

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 13, 2024
• Study Start: October 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)