Components of Chlorhexidine Gluconate Dressing

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CareFusion
ClinicalTrials.gov Identifier:
NCT01112020
First received: April 26, 2010
Last updated: March 21, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention Phase
Healthy
Device: CHG Catheter Dressing Patch
Device: Biopatch
Device: Tegaderm CHG
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official 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

Resource links provided by NLM:


Further study details as provided by CareFusion:

Primary Outcome Measures:
  • Chlorhexidine gluconate (CHG) level [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    CHG level in dressing after 7 days exposure to CHG-containing test articles


Secondary Outcome Measures:
  • Parachloroaniline (PCA) level [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    PCA level in dressing after 7 days exposure to CHG-containing test articles


Enrollment: 45
Study Start Date: April 2010
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CHG Catheter Dressing Patch Device: CHG Catheter Dressing Patch
2% CHG dressing applied to 7 sites
Active Comparator: Biopatch
Biopatch Protective Disk with CHG
Device: Biopatch
Biopatch applied to 7 sites
Active Comparator: Tegaderm CHG
Tegaderm CHG IV Securement Dressing
Device: Tegaderm CHG
Tegaderm CHG IV Securement Dressing applied to 7 sites

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01112020

Locations
United States, Missouri
Cetero Research
St. Charles, Missouri, United States, 63301
Sponsors and Collaborators
CareFusion
Investigators
Principal Investigator: Ramon Vargas, MD Cetero Research, San Antonio
  More Information

No publications provided

Responsible Party: CareFusion
ClinicalTrials.gov Identifier: NCT01112020     History of Changes
Other Study ID Numbers: S10-0088
Study First Received: April 26, 2010
Last Updated: March 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by CareFusion:
Chlorhexidine digluconate (CHG)
Biopatch Protective Disk
Tegaderm CHG IV (intravenous) Securement Dressing
parachloroaniline (PCA)
No condition being studied.
Assessing components of CHG-containing dressings after use.

Additional relevant MeSH terms:
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on April 15, 2014