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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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06733506
Enrollment
56
Registered
2024-12-13
Start date
2018-10-01
Completion date
2019-05-01
Last updated
2025-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

DRUGChlorhexidine 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).

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.

BEHAVIORALSkin 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.

Sponsors

Gabriel John Culbert
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Self-report intravenous drug use within past 30 days

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Frequency of Skin Swabbing2 weeks after randomizationThis 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

MeasureTime frameDescription
Swab Acceptability Rating2 weeks after randomization9-items measure swab acceptability, convenience, safety, ease of use, usefulness, tolerability, satisfaction, and self-efficacy
Safer Injection Knowledge and Behaviors2 weeks after randomization7-items measure participant knowledge, motivation, and behaviors about skin swabbing to prevent skin and soft tissue infections.

Other

MeasureTime frameDescription
Skin and Soft Tissue Infection Rate2 weeks after randomizationAssessed as redness, swelling, tenderness at an injection site.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026