Antimicrobial EffectivenessPhase 4NCT01366417
Topical Antimicrobial Effectiveness Testing
A Phase 4 study testing ChloraPrep One-Step and 70% isopropyl alcohol in people with Antimicrobial Effectiveness, run by C. R. Bard at 1 site in United States.
Trial summary
The primary objective of this study is to measure the antimicrobial effectiveness of ChloraPrep One-Step Frepp Applicator. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Antimicrobial Effectiveness
- What is being tested?
- ChloraPrep One-Step and 70% isopropyl alcohol
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Jun 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- in good general health
- have skin within 6 inches of the test sites that is free of tattoos, dermatoses, abrasions, cuts, lesions or other skin disorders.
Who cannot join
- topical or systemic antimicrobial exposure within 14 days prior to the Screen Visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Test for Preinjection Skin Preparation
The primary objective of this study is to measure the antimicrobial effectiveness of ChloraPrep One-Step Frepp Applicator.
- Conditions
- Antimicrobial Effectiveness
- Being tested
- ChloraPrep One-Step, 70% isopropyl alcohol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChloraPrep One-StepDrug
1.5 ml applicator patient preoperative skin preparation
70% isopropyl alcoholDrug
Also called Positive Control
Curity Alcohol Prep Pads
What is being measured
The primary outcome is the main question the study is designed to answer.
Antimicrobial Efficacy
Antimicrobial efficacy will be measured by the change (+/-) in bacterial count on the skin 30 seconds after a single application of test material relative to the baseline bacterial count.
Measured: 30 seconds after treatment
Antimicrobial Efficacy
Antimicrobial efficacy will be measured by the change (+/-) in bacterial count on the skin 10 minutes after a single application of test material relative to the baseline bacterial count.
Measured: 10 minutes after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Antimicrobial EffectivenessStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Muhammad H Bashir, MD, Principal investigator, Microbiotest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01366417
- Sponsor's protocol ID
- 371.1.04.19.11
- Status last verified
- Nov 2025
- First submitted
- 2 Jun 2011
- Last updated
- 11 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Test for Preinjection Skin Preparation
- ClinicalTrials.gov ID
- NCT01366417
- Acronym / sponsor ID
- 371.1.04.19.11
- Conditions
- Antimicrobial Effectiveness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 6 Jun 2011 (estimated)
- Results
- Posted 31 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to measure the antimicrobial effectiveness of ChloraPrep One-Step Frepp Applicator.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- in good general health
- have skin within 6 inches of the test sites that is free of tattoos, dermatoses, abrasions, cuts, lesions or other skin disorders.
Key exclusion criteria (1 listed)
- topical or systemic antimicrobial exposure within 14 days prior to the Screen Visit
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 |
|---|---|---|
| ChloraPrep One-Step1.5 ml applicator patient preoperative skin preparation | Drug | – |
| 70% isopropyl alcoholAlso: Positive ControlCurity Alcohol Prep Pads | Drug | – |
Primary outcome
Antimicrobial Efficacy
Time frame: 30 seconds after treatment
Antimicrobial efficacy will be measured by the change (+/-) in bacterial count on the skin 30 seconds after a single application of test material relative to the baseline bacterial count.
Antimicrobial Efficacy
Time frame: 10 minutes after treatment
Antimicrobial efficacy will be measured by the change (+/-) in bacterial count on the skin 10 minutes after a single application of test material relative to the baseline bacterial count.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Muhammad H Bashir, MD principal investigator
Microbiotest
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 ChloraPrep One-Step and 70% isopropyl alcohol in people with Antimicrobial Effectiveness, 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 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 11 Dec 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?
Yes. Results are posted in the registry (first posted 31 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Antimicrobial Efficacy (time frame: 30 seconds after treatment). The study lists 2 primary outcomes in all. 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 11 Dec 2025.