Components of Chlorhexidine Gluconate Dressing
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
1 other identifier
interventional
45
1 country
1
Brief Summary
The purpose of this study is to determine the contents of a chlorhexidine-containing dressing after use.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Apr 2010
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 26, 2010
CompletedFirst Posted
Study publicly available on registry
April 28, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedNovember 26, 2025
November 1, 2025
1 month
April 26, 2010
November 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Chlorhexidine gluconate (CHG) level
CHG level in dressing after 7 days exposure to CHG-containing test articles
1 week
Secondary Outcomes (1)
Parachloroaniline (PCA) level
7 days
Study Arms (3)
CHG Catheter Dressing Patch
EXPERIMENTALBiopatch
ACTIVE COMPARATORBiopatch Protective Disk with CHG
Tegaderm CHG
ACTIVE COMPARATORTegaderm CHG IV Securement Dressing
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- C. R. Bardlead
Study Sites (1)
Cetero Research
Saint Charles, Missouri, 63301, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Ramon Vargas, MD
Cetero Research, San Antonio
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2010
First Posted
April 28, 2010
Study Start
April 1, 2010
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
November 26, 2025
Record last verified: 2025-11