HealthyPhase 3NCT00692484
Pilot Evaluation of the Application Procedure on the Antimicrobial Effects of 2 Antiseptics
A Phase 3 study testing Chlorhexidine gluconate and Povidone iodine in people with Healthy, run by C. R. Bard at 1 site in United States.
Trial summary
Evaluate effect of application procedure on efficacy of 2 antiseptics for cleaning skin prior to surgery. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Chlorhexidine gluconate and Povidone iodine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Feb 2008
- Phase
- Phase 3
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Free of dermatoses, cuts, lesions, or other skin disorders around test sites
- must not have received topical or systemic antimicrobials, antibiotics, or steroids for 7 days prior to testing and agree to abstain from these materials until completion of the study
Who cannot join
- Exposure of test sites to antimicrobial agents, medicated soaps, medicated shampoos, or medicated lotions, use of biocide-treated pools or hot tubs, use of tanning beds, or sunbathing during the 7 day pre-test period or during the test period
- exposure of the test sites to strong detergents, solvents, or other irritants during the 7 day pre-test period or during the test period
- use of systemic or topical antibiotic medications, steroid medications, or any other product known to affect the normal microbial flora of the skin during the 7 day pre-test period or during the test period
- known allergy to latex (rubber), alcohols, inks, or tape adhesives, or to common antibacterial agents found in soaps, lotions, or ointments, particularly chlorhexidine gluconate and povidone iodine
- active skin rashes or breaks in the skin of the test sites
- currently active skin disease or inflammatory skin condition, including contact dermatitis
- showering or bathing within the 72 hour period prior to sampling
- participation in a clinical study in the past 7 days or current participation in another clinical study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Evaluation of the Effect of Application Procedure on the Antimicrobial Effects of an Aqueous CHG and a Traditional Iodophor Scrub Paint
Evaluate effect of application procedure on efficacy of 2 antiseptics for cleaning skin prior to surgery.
Read the detailed description
Evaluate the effect of application procedure on the antimicrobial properties of a new product and a currently marketed product. Study will be conducted using methods dictated by the FDA.
Study uses topical sampling from the abdomen and groin on intact skin and evaluates the germs. Effects of blotting versus not blotting will be assessed.
- Conditions
- Healthy
- Being tested
- Chlorhexidine gluconate, Povidone iodine
- Keywords
- Antimicrobial, Antisepsis, Topical antisepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine gluconateDrug
Also called ChloraPrep AQ
Chlorhexidine gluconate (2% w/v) in an aqueous base. Administered topically.
Povidone iodineDrug
Also called Betadine
Povidone iodine scrub and paint. Administer topically.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Chlorhexidine gluconate 2% Receives: Drug: Chlorhexidine gluconate |
| 2 | Active comparator | Povidone iodine scrub and paint Receives: Drug: Povidone iodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
3.0 log10 reduction in CFU/cm2 on inguinal sites, and 2.0 log10 reduction in CFU/cm2 on abdominal sites
Measured: 10 minutes and 6 hours after application of test solutions
Secondary outcomes (1)
Impact of blotting versus not blotting
Measured: Blotting and not blotting after 2 minute application with CHG and 5 minute application of iodophor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startOct 2007
- Primary completionFeb 2008
- Study completionFeb 2008
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.
- More trials run by C. R. BardThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daryl S Paulsen, PhD, Principal investigator, President and CEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00692484
- Sponsor's protocol ID
- 060629
- Status last verified
- Nov 2025
- First submitted
- 4 Jun 2008
- 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
- Pilot Evaluation of the Effect of Application Procedure on the Antimicrobial Effects of an Aqueous CHG and a Traditional Iodophor Scrub Paint
- ClinicalTrials.gov ID
- NCT00692484
- Acronym / sponsor ID
- 060629
- Conditions
- Healthy
- Keywords
- Antimicrobial, Antisepsis, Topical antisepsis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 6 Jun 2008 (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.
Evaluate effect of application procedure on efficacy of 2 antiseptics for cleaning skin prior to surgery.
Detailed description
Evaluate the effect of application procedure on the antimicrobial properties of a new product and a currently marketed product. Study will be conducted using methods dictated by the FDA.
Study uses topical sampling from the abdomen and groin on intact skin and evaluates the germs. Effects of blotting versus not blotting will be assessed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Chlorhexidine gluconateChlorhexidine gluconate 2% |
| 2 | Active comparator | Drug: Povidone iodinePovidone iodine scrub and paint |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Free of dermatoses, cuts, lesions, or other skin disorders around test sites
- must not have received topical or systemic antimicrobials, antibiotics, or steroids for 7 days prior to testing and agree to abstain from these materials until completion of the study
Key exclusion criteria (8 listed)
- Exposure of test sites to antimicrobial agents, medicated soaps, medicated shampoos, or medicated lotions, use of biocide-treated pools or hot tubs, use of tanning beds, or sunbathing during the 7 day pre-test period or during the test period
- exposure of the test sites to strong detergents, solvents, or other irritants during the 7 day pre-test period or during the test period
- use of systemic or topical antibiotic medications, steroid medications, or any other product known to affect the normal microbial flora of the skin during the 7 day pre-test period or during the test period
- known allergy to latex (rubber), alcohols, inks, or tape adhesives, or to common antibacterial agents found in soaps, lotions, or ointments, particularly chlorhexidine gluconate and povidone iodine
- active skin rashes or breaks in the skin of the test sites
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 gluconateAlso: ChloraPrep AQChlorhexidine gluconate (2% w/v) in an aqueous base. Administered topically. | Drug | 1 |
| Povidone iodineAlso: BetadinePovidone iodine scrub and paint. Administer topically. | Drug | 2 |
Primary outcome
3.0 log10 reduction in CFU/cm2 on inguinal sites, and 2.0 log10 reduction in CFU/cm2 on abdominal sites
Time frame: 10 minutes and 6 hours after application of test solutions
1 secondary outcome
Impact of blotting versus not blotting
Time frame: Blotting and not blotting after 2 minute application with CHG and 5 minute application of iodophor
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.
Daryl S Paulsen, PhD principal investigator
President and CEO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chlorhexidine gluconate and Povidone iodine 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 2 inclusion and 8 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
3.0 log10 reduction in CFU/cm2 on inguinal sites, and 2.0 log10 reduction in CFU/cm2 on abdominal sites (time frame: 10 minutes and 6 hours after application of test solutions). 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; AzTrials last refreshed its copy on 6 Nov 2026.