Components of Chlorhexidine Gluconate Dressing

C. R. Bard

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Device: Biopatch; Device: Tegaderm CHG; Device: CHG Catheter Dressing Patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT01112020

S10-0088

Details and patient eligibility

About

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

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 3 patient groups

CHG Catheter Dressing Patch

Experimental group

Treatment:

Device: CHG Catheter Dressing Patch

Biopatch

Active Comparator group

Description:

Biopatch Protective Disk with CHG

Treatment:

Device: Biopatch

Tegaderm CHG

Active Comparator group

Description:

Tegaderm CHG IV Securement Dressing

Treatment:

Device: Tegaderm CHG