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A Double-blind Randomized Placebo Controlled Clinical Trial Evaluating Effect of Chlorhexidine Gluconate 2% Cloth vs Placebo Cloth Baths on the Incidence of Central Line-Associated Blood Stream Infections in Outpatient Hematopoietic Stem Cell Transplant Patients

NCT ID: NCT03030989

Last Updated: 2020-12-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-06-30

Brief Summary

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This study evaluates the use of 2% CHG washcloths in an outpatient setting for adults after hematopoietic stem cell transplant in prevention of central line associated blood stream infections. Half of the participants will use 2% CHG washcloths and other half will use placebo washcloths.

Detailed Description

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Conditions

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Stem Cell Transplant Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Chlorhexidine Gluconate 2% Wipe

Group Type ACTIVE_COMPARATOR

Chlorhexidine Gluconate 2% Wipe

Intervention Type DRUG

Placebo wipe

Group Type PLACEBO_COMPARATOR

Placebo Wipe

Intervention Type DRUG

Interventions

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Chlorhexidine Gluconate 2% Wipe

Intervention Type DRUG

Placebo Wipe

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Admitted to the University of Chicago Hematopoietic Stem Cell Transplant Unit for transplant
* Age 18 and up

Exclusion Criteria

* Experienced an allergy or rash related to use of chlorhexidine washcloths or other chlorhexidine products
* Extensive open wounds
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB16-1059

Identifier Type: -

Identifier Source: org_study_id