HealthyPhase 1NCT01112020
Components of Chlorhexidine Gluconate Dressing
A Phase 1 study testing CHG Catheter Dressing Patch, Biopatch and Tegaderm CHG in people with Healthy, run by C. R. Bard at 1 site in United States.
Trial summary
The purpose of this study is to determine the contents of a chlorhexidine-containing dressing after use. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CHG Catheter Dressing Patch, Biopatch and Tegaderm CHG
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to May 2010
- Phase
- Phase 1
- 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
- Able to read, review and sign the Informed Consent
- Willing to shower using the same soap/cleansers from the Screening Visit through the end of the study
- Use study-approved contraceptive methods
Who cannot join
- Participation in an investigational study within 28 days prior to dosing.
- Clinically significant illness within 28 days prior to dosing.
- History of allergic responses to chlorhexidine, chlorhexidine-containing products, glycerol, adhesives, latex
- History of clinically significant skin disorders
- History of Type I diabetes mellitus, insulin-dependent diabetes mellitus(IDDM)
- History of significant dermatologic cancers (melanoma, squamous)
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- Known history of immunologic disorders
- Use immunosuppressive or other proscribed medications
- Use of skin products at the application site
- Significant history of allergies to soaps, lotions, emollients, ointments, creams
- History of drug or alcohol addiction within the past year
- Pregnant, lactating, breast-feeding, or intends to become pregnant during the course of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Components & Tolerability of Chlorhexidine Gluconate Dressing Patch Compared to BioPatch & Tegaderm Chlorhexidine Gluconate Securement Dressing After Application to Healthy Subjects Over a 7-day Period
The purpose of this study is to determine the contents of a chlorhexidine-containing dressing after use.
Read the detailed description
To characterize the chemical composition of the CHG (2% CHG) Catheter Dressing Patch as compared to Biopatch Protective Disk with CHG, and Tegaderm IV (intravenous) Securement Dressing over a wear period of 7 days.
- Conditions
- Healthy
- Being tested
- CHG Catheter Dressing Patch, Biopatch, Tegaderm CHG
- Keywords
- Chlorhexidine digluconate (CHG), Biopatch Protective Disk, Tegaderm CHG IV (intravenous) Securement Dressing, parachloroaniline (PCA), No condition being studied., Assessing components of CHG-containing dressings after use.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHG Catheter Dressing PatchDevice
2% CHG dressing applied to 7 sites
BiopatchDevice
Biopatch applied to 7 sites
Tegaderm CHGDevice
Tegaderm CHG IV Securement Dressing applied to 7 sites
| Study group | Role | What they receive |
|---|---|---|
| CHG Catheter Dressing Patch | Experimental | Not described Receives: Device: CHG Catheter Dressing Patch |
| Biopatch | Active comparator | Biopatch Protective Disk with CHG Receives: Device: Biopatch |
| Tegaderm CHG | Active comparator | Tegaderm CHG IV Securement Dressing Receives: Device: Tegaderm CHG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chlorhexidine gluconate (CHG) level
CHG level in dressing after 7 days exposure to CHG-containing test articles
Measured: 1 week
Secondary outcomes (1)
Parachloroaniline (PCA) level
PCA level in dressing after 7 days exposure to CHG-containing test articles
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ramon Vargas, MD, Principal investigator, Cetero Research, San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01112020
- Sponsor's protocol ID
- S10-0088
- Status last verified
- Nov 2025
- First submitted
- 26 Apr 2010
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Components & Tolerability of Chlorhexidine Gluconate Dressing Patch Compared to BioPatch & Tegaderm Chlorhexidine Gluconate Securement Dressing After Application to Healthy Subjects Over a 7-day Period
- ClinicalTrials.gov ID
- NCT01112020
- Acronym / sponsor ID
- S10-0088
- Conditions
- Healthy
- Keywords
- Chlorhexidine digluconate (CHG), Biopatch Protective Disk, Tegaderm CHG IV (intravenous) Securement Dressing, parachloroaniline (PCA), No condition being studied., Assessing components of CHG-containing dressings after use.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 28 Apr 2010 (estimated)
- 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 purpose of this study is to determine the contents of a chlorhexidine-containing dressing after use.
Detailed description
To characterize the chemical composition of the CHG (2% CHG) Catheter Dressing Patch as compared to Biopatch Protective Disk with CHG, and Tegaderm IV (intravenous) Securement Dressing over a wear period of 7 days.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CHG Catheter Dressing Patch | Experimental | Device: CHG Catheter Dressing Patch |
| Biopatch | Active comparator | Device: BiopatchBiopatch Protective Disk with CHG |
| Tegaderm CHG | Active comparator | Device: Tegaderm CHGTegaderm CHG IV Securement Dressing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able to read, review and sign the Informed Consent
- Willing to shower using the same soap/cleansers from the Screening Visit through the end of the study
- Use study-approved contraceptive methods
Key exclusion criteria (12 listed)
- Participation in an investigational study within 28 days prior to dosing.
- Clinically significant illness within 28 days prior to dosing.
- History of allergic responses to chlorhexidine, chlorhexidine-containing products, glycerol, adhesives, latex
- History of clinically significant skin disorders
- History of Type I diabetes mellitus, insulin-dependent diabetes mellitus(IDDM)
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 |
|---|---|---|
| CHG Catheter Dressing Patch2% CHG dressing applied to 7 sites | Device | CHG Catheter Dressing Patch |
| BiopatchBiopatch applied to 7 sites | Device | Biopatch |
| Tegaderm CHGTegaderm CHG IV Securement Dressing applied to 7 sites | Device | Tegaderm CHG |
Primary outcome
Chlorhexidine gluconate (CHG) level
Time frame: 1 week
CHG level in dressing after 7 days exposure to CHG-containing test articles
1 secondary outcome
Parachloroaniline (PCA) level
Time frame: 7 days
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 26 Nov 2025.
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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.
Ramon Vargas, MD principal investigator
Cetero Research, San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CHG Catheter Dressing Patch, Biopatch and Tegaderm CHG in people with Healthy, run by C. R. Bard 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 3 inclusion and 12 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 26 Nov 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Chlorhexidine gluconate (CHG) level (time frame: 1 week). 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 26 Nov 2025.