New antiseptic gel put to the test against surgical germs
NCT ID NCT00636480
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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60 people
The number who actually took part.
- Start date
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Oct 2007
- Finished
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Mar 2008
- Lead sponsor
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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
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16 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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BioScience Laboratories
Bozeman, Montana, 59715, United States
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