NCT06733506

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Gabriel John Culbert · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Chlorhexidine gluconate	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).
DRUG	Isopropyl Alcohol 70% Topical Application Solution	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.
BEHAVIORAL	Skin Prep Before Injecting Recreational/Street Drugs	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.

Timeline

• Start date: 2018-10-01
• Primary completion: 2019-05-01
• Completion: 2019-05-01
• First posted: 2024-12-13
• Last updated: 2025-08-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study