Components of Chlorhexidine Gluconate Dressing | NCT01112020

Studies
Components of Chlorhexidine Gluconate Dressing

NCT01112020

Sponsor

C. R. Bard

Status

Completed

Last Update Posted

Nov 26, 2025Actual

Enrollment

45Actual

Phase

Phase 1

Conditions

Healthy

Interventions

CHG Catheter Dressing Patch
Biopatch
Tegaderm CHG

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

May 2010Actual

Completion Date

May 2010Actual

First Submitted Date

Apr 26, 2010

First Submission Date that Met QC Criteria

Apr 27, 2010

First Posted Date

Apr 28, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 25, 2025

Last Update Posted Date

Nov 26, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CHG Catheter Dressing Patch	Experimental		Device: CHG Catheter Dressing Patch
Biopatch	Active Comparator	Biopatch Protective Disk with CHG	Device: Biopatch
Tegaderm CHG	Active Comparator	Tegaderm CHG IV Securement Dressing	Device: Tegaderm CHG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CHG Catheter Dressing Patch	Device	2% CHG dressing applied to 7 sites	CHG Catheter Dressing Patch

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided