Components of Chlorhexidine Gluconate Dressing

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.

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

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Device: CHG Catheter Dressing Patch
* Device: Biopatch
* Device: Tegaderm CHG


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHG Catheter Dressing Patch<br> | Device: CHG Catheter Dressing Patch<br>* 2% CHG dressing applied to 7 sites<br>|
| Active Comparator: Biopatch<br>Biopatch Protective Disk with CHG | Device: Biopatch<br>* Biopatch applied to 7 sites<br>|
| Active Comparator: Tegaderm CHG<br>Tegaderm CHG IV Securement Dressing | Device: Tegaderm CHG<br>* Tegaderm CHG IV Securement Dressing applied to 7 sites<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chlorhexidine gluconate (CHG) level | CHG level in dressing after 7 days exposure to CHG-containing test articles | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parachloroaniline (PCA) level | PCA level in dressing after 7 days exposure to CHG-containing test articles | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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.