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Components of Chlorhexidine Gluconate Dressing

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ClinicalTrials.gov Identifier: NCT01112020
Recruitment Status : Completed
First Posted : April 28, 2010
Last Update Posted : March 22, 2013
Sponsor:
Information provided by (Responsible Party):
CareFusion

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

Condition or disease Intervention/treatment Phase
Healthy Device: CHG Catheter Dressing Patch Device: Biopatch Device: Tegaderm CHG Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : April 2010
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Chlorhexidine gluconate (CHG) level [ Time Frame: 1 week ]
    CHG level in dressing after 7 days exposure to CHG-containing test articles


Secondary Outcome Measures :
  1. Parachloroaniline (PCA) level [ Time Frame: 7 days ]
    PCA level in dressing after 7 days exposure to CHG-containing test articles



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: CareFusion
ClinicalTrials.gov Identifier: NCT01112020     History of Changes
Other Study ID Numbers: S10-0088
First Posted: April 28, 2010    Key Record Dates
Last Update Posted: March 22, 2013
Last Verified: March 2013

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
Disinfectants
Dermatologic Agents