NCT01112020

CompletedPhase 1

Components of Chlorhexidine Gluconate Dressing

C. R. Bard Source

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Other study identifiers

Sponsor study identifier

S10-0088

Study Type

interventional

Actual enrollment (reported)

45

Locations

1 country

Sites

1

Timeline

Study Start

April 2010

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

May 2010

Actual (reported)

Study Completion

May 2010

Actual (reported)

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 45 participants
Study completion date: May 2010
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
April 2010
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
April 26, 2010
Actual (reported)
First Posted
April 28, 2010
Actual (reported)
Primary Completion
May 2010
Actual (reported)
Study Completion
May 2010
Actual (reported)

Last Updated: November 26, 2025
Status Verified: November 2025
Last Update Submitted: November 25, 2025

Conditions

Healthy

Keywords

Chlorhexidine digluconate (CHG)Biopatch Protective DiskTegaderm CHG IV (intravenous) Securement Dressingparachloroaniline (PCA)No condition being studied.Assessing components of CHG-containing dressings after use.

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

Parachloroaniline (PCA) level
7 days

Study Arms (3)

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

CHG Catheter Dressing PatchDevice

2% CHG dressing applied to 7 sites

CHG Catheter Dressing Patch

BiopatchDevice

Biopatch applied to 7 sites

Biopatch

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

C. R. Bard
Industrylead

Study Sites (1)

Cetero Research

Saint Charles, Missouri, 63301, United States

Study Officials

Ramon Vargas, MD
Cetero Research, San Antonio
PRINCIPAL INVESTIGATOR

Enrollment

45 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: OUTCOMES ASSESSOR
Purpose: OTHER
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 26, 2010

First Posted

April 28, 2010

Study Start

April 2010

Date type not reported

This date has not been verified as actual or estimated.

Phase 1

Completed

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Tegaderm CHGDevice

Tegaderm CHG IV Securement Dressing applied to 7 sites

Tegaderm CHG

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Use study-approved contraceptive methods

You may not qualify if:

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

Contact the study team to confirm eligibility.

Primary Completion

May 2010

Actual (reported)

Study Completion

May 2010

Actual (reported)

Last Updated

November 26, 2025

Record last verified: 2025-11

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01112020
Data provider: ClinicalTrials.gov
Source updated: 2025-11-26
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:32:17 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (3)

CHG Catheter Dressing Patch

Biopatch

Tegaderm CHG

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations