NCT01112020CompletedPhase 1
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
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- C. R. Bard
- Enrollment
- 45
- Locations
- 2
- Primary Endpoint
- Chlorhexidine gluconate (CHG) level
Study Overview
Brief Summary
The purpose of this study is to determine the contents of a chlorhexidine-containing dressing after use.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Chlorhexidine gluconate (CHG) level
Time Frame: 1 week
CHG level in dressing after 7 days exposure to CHG-containing test articles
Secondary Outcomes
- Parachloroaniline (PCA) level(7 days)
Investigators
Study Sites (2)
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