Preoperative Skin Preparation Evaluation

C. R. Bard

Status and phase: Completed; Phase 3

Conditions: Topical Antisepsis

Treatments: Drug: ChloraPrep One Step; Drug: Sterile saline; Drug: Chlorhexidine gluconate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00636480

070921-103

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups, including a placebo group

CHG 2%-26 ml

Experimental group

Description:

Chlorhexidine gluconate in an aqueous base, 26 ml applicator

Treatment:

Drug: Chlorhexidine gluconate

ChloraPrep 26 ml

Active Comparator group

Description:

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

Treatment:

Drug: ChloraPrep One Step

Sterile Saline

Placebo Comparator group

Description:

Sterile salt water administered topically.

Treatment:

Drug: Sterile saline