Components of Chlorhexidine Gluconate Dressing

NCT ID: NCT01112020

Last Updated: 2025-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CHG Catheter Dressing Patch

Group Type EXPERIMENTAL

CHG Catheter Dressing Patch

Intervention Type DEVICE

2% CHG dressing applied to 7 sites

Biopatch

Biopatch Protective Disk with CHG

Group Type ACTIVE_COMPARATOR

Biopatch

Intervention Type DEVICE

Biopatch applied to 7 sites

Tegaderm CHG

Tegaderm CHG IV Securement Dressing

Group Type ACTIVE_COMPARATOR

Tegaderm CHG

Intervention Type DEVICE

Tegaderm CHG IV Securement Dressing applied to 7 sites

Interventions

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CHG Catheter Dressing Patch

2% CHG dressing applied to 7 sites

Intervention Type DEVICE

Biopatch

Biopatch applied to 7 sites

Intervention Type DEVICE

Tegaderm CHG

Tegaderm CHG IV Securement Dressing applied to 7 sites

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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C. R. Bard

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ramon Vargas, MD

Role: PRINCIPAL_INVESTIGATOR

Cetero Research, San Antonio

Locations

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Cetero Research

Saint Charles, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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S10-0088

Identifier Type: -

Identifier Source: org_study_id

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