New antiseptic gel put to the test against surgical germs

NCT ID NCT00636480

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 ยท Last updated Jun 27, 2026

Summary

This study tested whether a new chlorhexidine-based skin cleanser can kill bacteria on the skin as well as an already-approved product. Sixty healthy adults had the new cleanser, the approved product, or a placebo applied to their skin before surgery. Researchers measured how many bacteria remained to see if the new product meets FDA standards for preventing infections.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Chlorhexidine gluconate (2% w/v) with or without isopropyl alcohol, applied topically to the skin
What this could lead to
If successful, this could confirm that the new skin-cleansing product is as effective as an already-approved one at reducing bacteria before surgery, helping prevent surgical infections.
What could go wrong
This is a small, early-phase study (60 people) testing only short-term germ reduction on the skin, not actual infection rates. Results may not translate to real-world surgical outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

60 people

The number who actually took part.

Start date

Oct 2007

Finished

Mar 2008

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Free of dermatoses, cuts, lesions, or other skin disorders on or around the test sites; no exposure to topical or systemic antimicrobials, antibiotics, or steroids (other than contraceptives, for the fourteen (14) day pre-test conditioning period and must agree to abstain from these materials until completion of the study Exclusion Criteria: * 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 fourteen(14) day pre-test conditioning period or during the test period; * Exposure of the test sites to strong detergent, solvents, or other irritants during the fourteen (14) day pre-test conditioning period or during the test period; * Use of systemic or topical antibiotic medications, steroid medications other than contraceptives, or any other product known to affect the normal microbial flora of the skin during the fourteen ()14) day pre-test conditioning period or during the test period; * Know of allergies to vinyl, latex (rubber), alcohols, metals, inks, or tape adhesives, or to common antibacterial agents found in soaps, lotions, or ointments, particularly chlorhexidine gluconate, and/or isopropyl alcohol; * A medical diagnosis of a physical condition, such as a current or recent severe illness, asthma, diabetes, hepatitis, an organ transplant, any immunocompromised conditions such as AIDS (or HIV positive), mitral valve prolapse, or a requirement to take antibiotics prior to dental procedures; * Pregnancy, plans to become pregnant within the pre-test and test periods of the study, or nursing a child; * Any active skin rashes or breaks in the skin of the test sites; * A currently active skin disease or inflammatory skin condition, including contact dermatitis; showering or bathing within the seventy-two (72) hour period prior to sampling; participation in another clinical study in the past thirty (30) days or current participation in another clinical study; * Any medical condition or use of any medications, that, in the opinion of the Study Director, should preclude participation; * Unwillingness to fulfill the performance requirements of the study.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Topical antisepsis are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • BioScience Laboratories

    Bozeman, Montana, 59715, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.