Test for Pre Operative Skin Preparations

Test for Pre Operative Skin Preparations: ChloraPrep Triple Swabsticks, Hibiclens and Sterile Triple Swabsticks (Using Sterile Deionized Water)

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.

Study Overview

• Status: Completed
• Conditions: Topical Antisepsis
• Intervention / Treatment: 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 (3 @ once); Other: Sterile swabstick with sterile water (one-at-a-time)

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 Type: Interventional
• Enrollment (Actual): 335
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Sterling, Virginia, United States, 20164
      • Microbiotest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CHG Swabstick (3 @ once); Chlorhexidine gluconate (CHG) 2% w/v CHG/isopropyl alcohol (IPA) 70% v/v - 3 swabsticks applied @ same time	Drug: CHG 2% w/v & IPA 70% v/v, swabstick (3 @ once).; 3 swabsticks topically applied at the same time to intact skin; Other Names: ChloraPrep Swabstick
Experimental: CHG Swabstick sequential; Chlorhexidine gluconate (CHG) 2% w/v and isopropyl alcohol (IPA) 70% v/v - 3 swabsticks applied sequentially	Drug: CHG 2% w/v & IPA 70% v/v swab applied sequentially; Chlorhexidine gluconate 2% w/v and isopropyl alcohol 70% v/v; 3 swabsticks applied sequentially to intact skin.; Other Names: ChloraPrep Swabstick
Active Comparator: Hibiclens; Chlorhexidine gluconate (CHG) 4% w/v in an aqueous base	Drug: Aqueous CHG 4% w/v applied according to mfr's directions; Chlorhexidine gluconate 4% w/v in an aqueous base applied according to mfr's directions. Step 1) 5 ml of Hibiclens applied to a sterile gauze pad. Step 2) Product applied to treatment area on intact skin for 2 minutes. Area dried with sterile towel or sterile gauze. Steps 1 and 2 repeated.; Other Names: Hibiclens
Placebo Comparator: Sterile water swab (3 @ once); Sterile swabstick wetted with sterile deionized water - 3 swabsticks applied at the same time.	Other: Sterile swabstick with sterile water (3 @ once); 3 sterile swabsticks wetted with sterile water topically applied to intact skin at the same time.
Placebo Comparator: Sterile water swabstick (sequential); Sterile swabstick wetted with sterile water--3 swabsticks applied sequentially.	Other: Sterile swabstick with sterile water (one-at-a-time); Sterile swabsticks wetted with sterile water topically applied to intact skin one-at-a-time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
log10 Reductions From Baseline for Each Test Parameter in CFU (Colony Forming Unit)/cm2 on Inguinal and Abdominal Sites	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.	10 minutes and 6 hours after application of test solutions

Collaborators and Investigators

• Sponsor: C. R. Bard
• Investigators: Principal Investigator: M. Hamid Bashir, MD, Medical director

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2007
• Primary Completion (Actual): April 27, 2008
• Study Completion (Actual): June 19, 2008

Study Registration Dates

• First Submitted: November 26, 2008
• First Submitted That Met QC Criteria: November 26, 2008
• First Posted (Estimated): December 1, 2008

Study Record Updates

• Last Update Posted (Estimated): December 11, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: antimicrobial; antisepsis
• Additional Relevant MeSH Terms: Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Protein Precursors; chlorhexidine gluconate; Chromogranins
• Other Study ID Numbers: ENT 371-121