Healthy
Conditions
Keywords
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.
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.
Interventions
DEVICECHG Catheter Dressing Patch
2% CHG dressing applied to 7 sites
DEVICEBiopatch
Biopatch applied to 7 sites
DEVICETegaderm CHG
Tegaderm CHG IV Securement Dressing applied to 7 sites
Sponsors
C. R. Bard
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chlorhexidine gluconate (CHG) level | 1 week | CHG level in dressing after 7 days exposure to CHG-containing test articles |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parachloroaniline (PCA) level | 7 days | PCA level in dressing after 7 days exposure to CHG-containing test articles |
Countries
United States
Outcome results
None listed