Opioid Use DisorderPhase 4NCT06733506
A Pilot Study to Evaluate Skin Swabbing With Chlorhexidine to Prevent Skin And Soft Tissue Infections Among People Who Inject Drugs
A Phase 4 study testing Chlorhexidine gluconate, Isopropyl Alcohol 70% Topical Application Solution and Skin Prep Before Injecting Recreational/Street Drugs in people with Opioid Use Disorder and Injection Drug Use, run by Gabriel John Culbert at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Use Disorder, Injection Drug Use, Skin and Soft Tissue Infections (SSTIs)
- What is being tested?
- Chlorhexidine gluconate, Isopropyl Alcohol 70% Topical Application Solution and Skin Prep Before Injecting Recreational/Street Drugs
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 1 May 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-report intravenous drug use within past 30 days
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois Chicago
Chicago, Illinois, 60612
About this study
Official 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
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.
Read the 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.
- Being tested
- Chlorhexidine gluconate, Isopropyl Alcohol 70% Topical Application Solution, Skin Prep Before Injecting Recreational/Street Drugs
- Keywords
- opioid use disorder, injection drug use, skin and soft tissue infection, chlorhexidine, people who inject drugs
- Medical subject headings
- Opioid-Related Disorders, Soft Tissue Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine gluconateDrug
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 SolutionDrug
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 DrugsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Isopropyl Alcohol 70% Topical Application Solution; Behavioral: Skin Prep Before Injecting Recreational/Street Drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 weeks after randomization
Secondary outcomes (2)
Swab Acceptability Rating
9-items measure swab acceptability, convenience, safety, ease of use, usefulness, tolerability, satisfaction, and self-efficacy
Measured: 2 weeks after randomization
Safer Injection Knowledge and Behaviors
7-items measure participant knowledge, motivation, and behaviors about skin swabbing to prevent skin and soft tissue infections.
Measured: 2 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start1 Oct 2018
- Primary completion1 May 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gabriel John Culbert
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gabriel John Culbert, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733506
- Sponsor's protocol ID
- 2018-0488
- Status last verified
- Jul 2025
- First submitted
- 10 Dec 2024
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data requests referencing Protocol #2018-0488 should be emailed to Gabriel Culbert (gculbert@uic.edu) and include a statement of how the data will be used and stored.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06733506
- Acronym / sponsor ID
- 2018-0488
- Keywords
- opioid use disorder, injection drug use, skin and soft tissue infection, chlorhexidine, people who inject drugs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Gabriel John CulbertUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine Swabs | Experimental | Drug: Chlorhexidine gluconate, Behavioral: Skin Prep Before Injecting Recreational/Street DrugsParticipants 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 | Active comparator | Drug: Isopropyl Alcohol 70% Topical Application Solution, Behavioral: Skin Prep Before Injecting Recreational/Street DrugsParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Self-report intravenous drug use within past 30 days
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlorhexidine gluconateChlorhexidine 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 | Chlorhexidine Swabs |
| Isopropyl Alcohol 70% Topical Application SolutionIsopropyl alcohol (IPA), a topical skin disinfectant, is effective against many pathogens and is commonly supplied as 2x2 inch pre-soaked, single-use gauze wipes. | Drug | Usual Care |
| Skin Prep Before Injecting Recreational/Street DrugsDuring 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. | Behavioural | Chlorhexidine Swabs, Usual Care |
Primary outcome
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)
2 secondary outcomes
Swab Acceptability Rating
Time frame: 2 weeks after randomization
Safer Injection Knowledge and Behaviors
Time frame: 2 weeks after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: No. Data requests referencing Protocol #2018-0488 should be emailed to Gabriel Culbert (gculbert@uic.edu) and include a statement of how the data will be used and stored.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chlorhexidine gluconate, Isopropyl Alcohol 70% Topical Application Solution and Skin Prep Before Injecting Recreational/Street Drugs in people with Opioid Use Disorder and Injection Drug Use, run by Gabriel John Culbert at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Skin Swabbing (time frame: 2 weeks after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.