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Completed

NCT Number: NCT01112020

Components of Chlorhexidine Gluconate Dressing

The purpose of this study is to determine the contents of a chlorhexidine-containing dressing after use.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cetero Research

Saint Charles, Missouri, 63301, United States

About this study

To characterize the chemical composition of the CHG (2% CHG) Catheter Dressing Patch as compared to Biopatch Protective Disk with CHG, and Tegaderm IV (intravenous) Securement Dressing over a wear period of 7 days.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able to read, review and sign the Informed Consent
  • Willing to shower using the same soap/cleansers from the Screening Visit through the end of the study
  • Use study-approved contraceptive methods

Exclusion criteria

  • Participation in an investigational study within 28 days prior to dosing.
  • Clinically significant illness within 28 days prior to dosing.
  • History of allergic responses to chlorhexidine, chlorhexidine-containing products, glycerol, adhesives, latex
  • History of clinically significant skin disorders
  • History of Type I diabetes mellitus, insulin-dependent diabetes mellitus(IDDM)
  • History of significant dermatologic cancers (melanoma, squamous)
  • Known history of immunologic disorders
  • Use immunosuppressive or other proscribed medications
  • Use of skin products at the application site
  • Significant history of allergies to soaps, lotions, emollients, ointments, creams
  • History of drug or alcohol addiction within the past year
  • Pregnant, lactating, breast-feeding, or intends to become pregnant during the course of the study

Treatment and study plan

CHG Catheter Dressing Patch

Device

2% CHG dressing applied to 7 sites

Biopatch

Device

Biopatch applied to 7 sites

Tegaderm CHG

Device

Tegaderm CHG IV Securement Dressing applied to 7 sites

Primary outcomes

  1. Chlorhexidine gluconate (CHG) level

    Time frame: 1 week

    CHG level in dressing after 7 days exposure to CHG-containing test articles

Secondary outcomes

  1. Parachloroaniline (PCA) level

    Time frame: 7 days

    PCA level in dressing after 7 days exposure to CHG-containing test articles

Sponsors and collaborators

Lead sponsor

C. R. Bard

Industry

Registry information

Official study title

Components & Tolerability of Chlorhexidine Gluconate Dressing Patch Compared to BioPatch & Tegaderm Chlorhexidine Gluconate Securement Dressing After Application to Healthy Subjects Over a 7-day Period

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 28, 2010
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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