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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014