Components of Chlorhexidine Gluconate Dressing

Phase 1

Completed

• Conditions: Healthy
• Interventions: Device: Biopatch; Device: CHG Catheter Dressing Patch; Device: Tegaderm CHG

• Registration Number: NCT01112020
• Lead Sponsor: CareFusion

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 Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-26
• Study First Submitted QC: 2010-04-27
• Study First Posted: 2010-04-28
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-21
• Last Update Posted: 2013-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biopatch	Biopatch	Biopatch Protective Disk with CHG
CHG Catheter Dressing Patch	CHG Catheter Dressing Patch	-
Tegaderm CHG	Tegaderm CHG	Tegaderm CHG IV Securement Dressing

Primary Outcome Measures

Name	Time	Method
Chlorhexidine gluconate (CHG) level	1 week	CHG level in dressing after 7 days exposure to CHG-containing test articles

Secondary Outcome Measures

Name	Time	Method
Parachloroaniline (PCA) level	7 days	PCA level in dressing after 7 days exposure to CHG-containing test articles

Trial Locations

Locations (1)

Cetero Research; 🇺🇸 St. Charles, Missouri, United States