Topical AntisepsisPhase 3NCT00799812

Test for Pre Operative Skin Preparations

A Phase 3 study testing CHG 2% w/v & IPA 70% v/v, swabstick (3 @ once)., CHG 2% w/v & IPA 70% v/v swab applied sequentially and Aqueous CHG 4% w/v applied according to mfr's directions in people with Topical Antisepsis, run by C. R. Bard at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Compare 2 application techniques of ChloraPrep Swabstick--3 swabsticks at once versus 3 swabsticks used sequentially. Hibiclens applied according to the manufacturer's directions. Sterile swabsticks (wetted with sterile deionizd water) applied using the same method as the ChloraPrep Swabstick. Read more about this study

Who is it for?: Ages 16 years and olderHealthy volunteers can take part
Conditions the study is for: Topical Antisepsis
What is being tested?: CHG 2% w/v & IPA 70% v/v, swabstick (3 @ once)., CHG 2% w/v & IPA 70% v/v swab applied sequentially and Aqueous CHG 4% w/v applied according to mfr's directions
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 335 participants
Where: 1 siteUnited States
Study dates: 13 Nov 2007to 19 Jun 2008
Phase: Phase 3
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 16 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Subjects must read and sign an Informed Consent Form and be cooperative.
Subjects must be in good general health.
Subjects must have skin within 6 inches of the test site that is free of tattoos, dermatoses, abrasions, cuts, lesions, or other skin disorders.

Who cannot join

Use of systemic or topical antimicrobials during the 2-week pretest conditioning period. This restriction includes but is not limited to shampoos, lotions, soaps, baby powders, and materials, such as solvents, acids, or alkalis.
A medical diagnosis of a physical condition, which would preclude participation such as: diabetes, hepatitis, an organ transplant, a medical surgical implant, or an immunocompromised system.
Any medical condition that in the opinion of the investigator would preclude participation.
Bathed in chemically treated pools or hot tubs 2 weeks prior to any microbial sampling.
Used UV tanning lamps 2 weeks prior to any microbial sampling.
Bathing or showering less than 48 hours prior to any microbial sampling.

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Known sensitivity to chlorhexidine gluconate.
Known sensitivity to latex (rubber).
Known sensitivity to fragrances.
Pregnant or nursing.
Unwillingness to fulfill the performance requirements of the study.
Subjects who have completed part or all of the study will not be reentered in the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Microbiotest
Sterling, Virginia, 20164

Other trials in United States

About this study

Official title: Test for Pre Operative Skin Preparations: ChloraPrep Triple Swabsticks, Hibiclens and Sterile Triple Swabsticks (Using Sterile Deionized Water)

Read the detailed description

Determine differences (if any) in 2 different application techniques of ChloraPrep Swabstick--3 swabsticks at once versus 3 swabsticks used sequentially. Hibiclens, a liquid antibacterial soap, applied according to the manufacturer's directions as a active/positive comparison. Sterile swabsticks (wetted with sterile deionized water) applied as a negative comparison using the same method as the ChloraPrep swabstick.

Study uses topical sampling from the abdomen and the groin on intact skin and evaluates the germs left on the skin after treatment with ChloraPrep Swabsticks.

Conditions: Topical Antisepsis
Being tested: CHG 2% w/v & IPA 70% v/v, swabstick (3 @ once)., CHG 2% w/v & IPA 70% v/v swab applied sequentially, Aqueous CHG 4% w/v applied according to mfr's directions, Sterile swabstick with sterile water (3 @ once), Sterile swabstick with sterile water (one-at-a-time)
Keywords: antimicrobial, antisepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CHG 2% w/v & IPA 70% v/v, swabstick (3 @ once).Drug
Also called ChloraPrep Swabstick
3 swabsticks topically applied at the same time to intact skin
CHG 2% w/v & IPA 70% v/v swab applied sequentiallyDrug
Also called ChloraPrep Swabstick
Chlorhexidine gluconate 2% w/v and isopropyl alcohol 70% v/v; 3 swabsticks applied sequentially to intact skin.
Aqueous CHG 4% w/v applied according to mfr's directionsDrug
Also called Hibiclens
Chlorhexidine gluconate 4% w/v in an aqueous base applied according to mfr's directions. Step 1) 5 ml of Hibiclens applied to a sterile gauze pad. Step 2) Product applied to treatment area on intact skin for 2 minutes. Area dried with sterile towel or sterile gauze. Steps 1 and 2 repeated.
Sterile swabstick with sterile water (3 @ once)Other
3 sterile swabsticks wetted with sterile water topically applied to intact skin at the same time.
Sterile swabstick with sterile water (one-at-a-time)Other
Sterile swabsticks wetted with sterile water topically applied to intact skin one-at-a-time.

Study groups in NCT00799812
Study group	Role	What they receive
CHG Swabstick (3 @ once)	Experimental	Chlorhexidine gluconate (CHG) 2% w/v CHG/isopropyl alcohol (IPA) 70% v/v - 3 swabsticks applied @ same time Receives: Drug: CHG 2% w/v & IPA 70% v/v, swabstick (3 @ once).
CHG Swabstick sequential	Experimental	Chlorhexidine gluconate (CHG) 2% w/v and isopropyl alcohol (IPA) 70% v/v - 3 swabsticks applied sequentially Receives: Drug: CHG 2% w/v & IPA 70% v/v swab applied sequentially
Hibiclens	Active comparator	Chlorhexidine gluconate (CHG) 4% w/v in an aqueous base Receives: Drug: Aqueous CHG 4% w/v applied according to mfr's directions
Sterile water swab (3 @ once)	Placebo comparator	Sterile swabstick wetted with sterile deionized water - 3 swabsticks applied at the same time. Receives: Other: Sterile swabstick with sterile water (3 @ once)
Sterile water swabstick (sequential)	Placebo comparator	Sterile swabstick wetted with sterile water--3 swabsticks applied sequentially. Receives: Other: Sterile swabstick with sterile water (one-at-a-time)

What is being measured

The primary outcome is the main question the study is designed to answer.

log10 Reductions From Baseline for Each Test Parameter in CFU (Colony Forming Unit)/cm2 on Inguinal and Abdominal Sites
The bacterial reductions achieved by the test products and the controls using 2 different application techniques at 10-minute and 6-hour sampling intervals for both groin and abdominal sites were evaluated.
Measured: 10 minutes and 6 hours after application of test solutions

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Nov 200719 Jun 2008

First posted1 Dec 2008 (estimated)
Study start13 Nov 2007
Primary completion27 Apr 2008
Study completion19 Jun 2008

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 Topical AntisepsisStudies 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 3
Primary purpose: Other
Allocation: Randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 335 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00799812
Sponsor's protocol ID: ENT 371-121
Status last verified: Nov 2025
First submitted: 26 Nov 2008
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 Pre Operative Skin Preparations: ChloraPrep Triple Swabsticks, Hibiclens and Sterile Triple Swabsticks (Using Sterile Deionized Water)
ClinicalTrials.gov ID: NCT00799812
Acronym / sponsor ID: ENT 371-121
Conditions: Topical Antisepsis
Keywords: antimicrobial, antisepsis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 335 participants (actual)
Lead sponsor: C. R. BardIndustry (pharma, biotech, devices)
Study start: 13 Nov 2007 (actual)
Primary completion: 27 Apr 2008 (actual)
Study completion: 19 Jun 2008 (actual)
First posted: 1 Dec 2008 (estimated)
Results: Posted 27 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study uses topical sampling from the abdomen and the groin on intact skin and evaluates the germs left on the skin after treatment with ChloraPrep Swabsticks.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Single group
Masking: Single blind (outcomes assessor)
Number of arms: 5

Arm	Type	Receives
CHG Swabstick (3 @ once)	Experimental	Drug: CHG 2% w/v & IPA 70% v/v, swabstick (3 @ once).Chlorhexidine gluconate (CHG) 2% w/v CHG/isopropyl alcohol (IPA) 70% v/v - 3 swabsticks applied @ same time
CHG Swabstick sequential	Experimental	Drug: CHG 2% w/v & IPA 70% v/v swab applied sequentiallyChlorhexidine gluconate (CHG) 2% w/v and isopropyl alcohol (IPA) 70% v/v - 3 swabsticks applied sequentially
Hibiclens	Active comparator	Drug: Aqueous CHG 4% w/v applied according to mfr's directionsChlorhexidine gluconate (CHG) 4% w/v in an aqueous base
Sterile water swab (3 @ once)	Placebo comparator	Other: Sterile swabstick with sterile water (3 @ once)Sterile swabstick wetted with sterile deionized water - 3 swabsticks applied at the same time.
Sterile water swabstick (sequential)	Placebo comparator	Other: Sterile swabstick with sterile water (one-at-a-time)Sterile swabstick wetted with sterile water--3 swabsticks applied sequentially.

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Subjects must read and sign an Informed Consent Form and be cooperative.
Subjects must be in good general health.
Subjects must have skin within 6 inches of the test site that is free of tattoos, dermatoses, abrasions, cuts, lesions, or other skin disorders.

Key exclusion criteria (12 listed)

Use of systemic or topical antimicrobials during the 2-week pretest conditioning period. This restriction includes but is not limited to shampoos, lotions, soaps, baby powders, and materials, such as solvents, acids, or alkalis.
A medical diagnosis of a physical condition, which would preclude participation such as: diabetes, hepatitis, an organ transplant, a medical surgical implant, or an immunocompromised system.
Any medical condition that in the opinion of the investigator would preclude participation.
Bathed in chemically treated pools or hot tubs 2 weeks prior to any microbial sampling.
Used UV tanning lamps 2 weeks prior to any microbial sampling.

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 2% w/v & IPA 70% v/v, swabstick (3 @ once).Also: ChloraPrep Swabstick3 swabsticks topically applied at the same time to intact skin	Drug	CHG Swabstick (3 @ once)
CHG 2% w/v & IPA 70% v/v swab applied sequentiallyAlso: ChloraPrep SwabstickChlorhexidine gluconate 2% w/v and isopropyl alcohol 70% v/v; 3 swabsticks applied sequentially to intact skin.	Drug	CHG Swabstick sequential
Aqueous CHG 4% w/v applied according to mfr's directionsAlso: HibiclensChlorhexidine gluconate 4% w/v in an aqueous base applied according to mfr's directions. Step 1) 5 ml of Hibiclens applied to a sterile gauze pad. Step 2) Product applied to treatment area on intact skin for 2 minutes. Area dried with sterile towel or sterile gauze. Steps 1 and 2 repeated.	Drug	Hibiclens
Sterile swabstick with sterile water (3 @ once)3 sterile swabsticks wetted with sterile water topically applied to intact skin at the same time.	Other	Sterile water swab (3 @ once)
Sterile swabstick with sterile water (one-at-a-time)Sterile swabsticks wetted with sterile water topically applied to intact skin one-at-a-time.	Other	Sterile water swabstick (sequential)

Primary outcome

log10 Reductions From Baseline for Each Test Parameter in CFU (Colony Forming Unit)/cm2 on Inguinal and Abdominal Sites
Time frame: 10 minutes and 6 hours after application of test solutions
The bacterial reductions achieved by the test products and the controls using 2 different application techniques at 10-minute and 6-hour sampling intervals for both groin and abdominal sites were evaluated.

Results and safety

Results posted to the registry on 27 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Study Participants	335	335

Primary outcome: log10 Reductions From Baseline for Each Test Parameter in CFU (Colony Forming Unit)/cm2 on Inguinal and Abdominal Sites

Time frame: 10 minutes and 6 hours after application of test solutions. Mean (Standard Deviation). Unit: Average log10 reductions in CFU/cm2

Measure	CHG Swabstick (3 @ Once) n = 111	CHG Swabstick Sequential n = 112	Hibiclens n = 111	Sterile Water Swab (3 @ Once) n = 111	Sterile Water Swabstick (Sequential) n = 112
Groin site - 10 minutes	3.51 (0.62)	3.44 (0.64)	3.15 (0.53)	0.92 (0.47)	0.97 (0.55)
Groin site - 6 hours	3.22 (0.65)	3.24 (0.58)	2.89 (0.62)	0.82 (0.47)	0.85 (0.58)
Abdomen site - 10 minutes	2.56 (0.50)	2.58 (0.48)	2.76 (0.49)	0.54 (0.37)	0.50 (0.35)
Abdomen site - 6 hours	2.38 (0.60)	2.39 (0.64)	2.51 (0.66)	0.47 (0.38)	0.46 (0.39)

Population analysed: Measure Analysis Population Description: Number analyzed is not equal to participants treated but rather equal to the number of treated sites for individuals who met the baseline bacterial load criteria on treatment day

Adverse events

Time frame: During the study through the 6-hour time point evaluations. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CHG Swabstick (3 @ Once)	0 of 139 (0%)	0 of 139 (0%)	0 of 139
CHG Swabstick Sequential	0 of 138 (0%)	0 of 138 (0%)	0 of 138
Hibiclens	0 of 133 (0%)	0 of 133 (0%)	0 of 133
Sterile Water Swab (3 @ Once)	0 of 132 (0%)	0 of 132 (0%)	0 of 132
Sterile Water Swabstick (Sequential)	0 of 126 (0%)	0 of 126 (0%)	0 of 126

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.

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.

M. Hamid Bashir, MD principal investigator

Medical Director

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 27 May 2021). 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?

log10 Reductions From Baseline for Each Test Parameter in CFU (Colony Forming Unit)/cm2 on Inguinal and 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?

On the ClinicalTrials.gov record for NCT00799812.

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.