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Completed

NCT Number: NCT06733506

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Illinois Chicago

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Self-report intravenous drug use within past 30 days

Exclusion criteria

  • None

Treatment and study plan

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).

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.

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.

Primary outcomes

  1. Frequency of Skin Swabbing

    Time frame: 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)

Secondary outcomes

  1. Swab Acceptability Rating

    Time frame: 2 weeks after randomization

    9-items measure swab acceptability, convenience, safety, ease of use, usefulness, tolerability, satisfaction, and self-efficacy

  2. Safer Injection Knowledge and Behaviors

    Time frame: 2 weeks after randomization

    7-items measure participant knowledge, motivation, and behaviors about skin swabbing to prevent skin and soft tissue infections.

Other outcomes

  1. Skin and Soft Tissue Infection Rate

    Time frame: 2 weeks after randomization

    Assessed as redness, swelling, tenderness at an injection site.

Sponsors and collaborators

Lead sponsor

Gabriel John Culbert

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 13, 2024
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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