Test for Pre Operative Skin Preparations

Phase 3

Completed

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

• Registration Number: NCT00799812
• Lead Sponsor: CareFusion

Brief 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.

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.

Study Timeline

• Study Start: 2007-11-13
• Primary Completion: 2008-04-27
• Study Completion: 2008-06-19
• Study First Submitted: 2008-11-26
• Study First Submitted QC: 2008-11-26
• Study First Posted: 2008-12-01
• Results First Submitted: 2018-03-23
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-26
• Last Update Submitted: 2021-05-26
• Results First Posted: 2021-05-27
• Last Update Posted: 2021-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 335

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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.
• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sterile water swab (3 @ once)	Sterile swabstick with sterile water (3 @ once)	Sterile swabstick wetted with sterile deionized water - 3 swabsticks applied at the same time.
CHG Swabstick (3 @ once)	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	CHG 2% w/v & IPA 70% v/v swab applied sequentially	Chlorhexidine gluconate (CHG) 2% w/v and isopropyl alcohol (IPA) 70% v/v - 3 swabsticks applied sequentially
Hibiclens	Aqueous CHG 4% w/v applied according to mfr's directions	Chlorhexidine gluconate (CHG) 4% w/v in an aqueous base
Sterile water swabstick (sequential)	Sterile swabstick with sterile water (one-at-a-time)	Sterile swabstick wetted with sterile water--3 swabsticks applied sequentially.

Primary Outcome Measures

Name	Time	Method
log10 Reductions From Baseline for Each Test Parameter in CFU (Colony Forming Unit)/cm2 on Inguinal and Abdominal Sites	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.

Trial Locations

Locations (1)

Microbiotest; 🇺🇸 Sterling, Virginia, United States