Test for Pre Operative Skin Preparations

NCT00799812 | Completed Phase 3 Results

• 1 other identifier: ENT 371-121
• Study Type: interventional
• Target: 335
• Locations: 1 country
• Sites: 1

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.

Conditions

Topical Antisepsis

Keywords

antimicrobial; antisepsis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (5)

CHG Swabstick (3 @ once)

EXPERIMENTAL

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).

CHG Swabstick sequential

EXPERIMENTAL

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

Hibiclens

ACTIVE COMPARATOR

Chlorhexidine gluconate (CHG) 4% w/v in an aqueous base

Drug: Aqueous CHG 4% w/v applied according to mfr's directions

Sterile water swab (3 @ once)

PLACEBO COMPARATOR

Sterile swabstick wetted with sterile deionized water - 3 swabsticks applied at the same time.

Other: Sterile swabstick with sterile water (3 @ once)

Sterile water swabstick (sequential)

PLACEBO COMPARATOR

Sterile swabstick wetted with sterile water--3 swabsticks applied sequentially.

Other: Sterile swabstick with sterile water (one-at-a-time)

Interventions

CHG 2% w/v & IPA 70% v/v, swabstick (3 @ once). DRUG

3 swabsticks topically applied at the same time to intact skin

Also known as: ChloraPrep Swabstick

CHG Swabstick (3 @ once)

CHG 2% w/v & IPA 70% v/v swab applied sequentially DRUG

Chlorhexidine gluconate 2% w/v and isopropyl alcohol 70% v/v; 3 swabsticks applied sequentially to intact skin.

Also known as: ChloraPrep Swabstick

CHG Swabstick sequential

Aqueous CHG 4% w/v applied according to mfr's directions DRUG

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.

Also known as: Hibiclens

Hibiclens

Sterile swabstick with sterile water (3 @ once) OTHER

3 sterile swabsticks wetted with sterile water topically applied to intact skin at the same time.

Sterile water swab (3 @ once)

Sterile swabstick with sterile water (one-at-a-time) OTHER

Sterile swabsticks wetted with sterile water topically applied to intact skin one-at-a-time.

Sterile water swabstick (sequential)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (1)

Microbiotest

Sterling, Virginia, 20164, United States

Location

MeSH Terms

Interventions

Chromogranins; chlorhexidine gluconate

Intervention Hierarchy (Ancestors)

Nerve Tissue Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors

Results Point of Contact

• Title: Erin Zook
• Organization: BD

erin.zook@bd.com

847-362-9047

Study Officials

• M. Hamid Bashir, MD

  Medical Director

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2008
• First Posted: December 1, 2008
• Study Start: November 13, 2007
• Primary Completion: April 27, 2008
• Study Completion: June 19, 2008
• Last Updated: December 11, 2025
• Results First Posted: May 27, 2021

Record last verified: 2025-11

Locations

US (1)