Preoperative Skin Preparation Evaluation

NCT ID: NCT00636480

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2008-03-31

Brief Summary

Determine the antimicrobial properties of a proposed new product and an already approved product and a placebo (no drug). Study will be conducted using methods dictated by the FDA.

Detailed Description

Determine the antimicrobial properties of a proposed new product and an already approved product and a placebo (no drug). Study will be conducted using methods dictated by the FDA.

This study uses topical sampling from the abdomen and the groin on intact skin and evaluates the germs left on the skin after treatment with the proposed new product, the currently approved product and the placebo.

Conditions

Topical Antisepsis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

CHG 2%-26 ml

Chlorhexidine gluconate in an aqueous base, 26 ml applicator

Group Type: EXPERIMENTAL

Chlorhexidine gluconate

Intervention Type: DRUG

Chlorhexidine gluconate (2% w/v) in an aqueous base, 26 ml applicator. Active drug contains alcohol and the placebo contains no drug. Administered topically.

ChloraPrep 26 ml

ChloraPrep One-Step 26 ml Active drug contains chlorhexidine gluconate and alcohol

Group Type: ACTIVE_COMPARATOR

ChloraPrep One Step

Intervention Type: DRUG

Administer topically

Sterile Saline

Sterile salt water administered topically.

Group Type: PLACEBO_COMPARATOR

Sterile saline

Intervention Type: DRUG

0.9% NaCl solution

Interventions

Chlorhexidine gluconate

Chlorhexidine gluconate (2% w/v) in an aqueous base, 26 ml applicator. Active drug contains alcohol and the placebo contains no drug. Administered topically.

Intervention Type: DRUG

ChloraPrep One Step

Administer topically

Intervention Type: DRUG

Sterile saline

0.9% NaCl solution

Intervention Type: DRUG

Other Intervention Names

ChloraPrep AQ; Chlorhexidine gluconate 2% w/v and 70% v/v isopropyl alcohol; Physiologic saline (0.9% NaCl)

Eligibility Criteria

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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

C. R. Bard

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daryl S Paulsen, PhD

Role: PRINCIPAL_INVESTIGATOR

President and CEO

Locations

BioScience Laboratories

Bozeman, Montana, United States

Countries

United States

Other Identifiers

070921-103

Identifier Type: -

Identifier Source: org_study_id