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

Phase 2

Completed

• Conditions: Stem Cell Transplant Complications
• Interventions: Drug: Placebo Wipe; Drug: Chlorhexidine Gluconate 2% Wipe

• Registration Number: NCT03030989
• Lead Sponsor: University of Chicago

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-01-23
• Study First Submitted QC: 2017-01-23
• Study First Posted: 2017-01-25
• Primary Completion: 2019-01-02
• Study Completion: 2019-06
• Results First Submitted: 2020-09-30
• Status Verified: 2020-11
• Results First Submitted QC: 2020-11-16
• Last Update Submitted: 2020-11-16
• Results First Posted: 2020-12-10
• Last Update Posted: 2020-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

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Exclusion Criteria

• Experienced an allergy or rash related to use of chlorhexidine washcloths or other chlorhexidine products
• Extensive open wounds

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo wipe	Placebo Wipe	-
Chlorhexidine Gluconate 2% Wipe	Chlorhexidine Gluconate 2% Wipe	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Primary Blood Stream Infections	14 weeks	Blood stream infections are defined by the presence of bacteria in the blood
Number of Participants With Clinical (Culture-negative) Sepsis	14 weeks	Clinical (culture-negative) sepsis is defined by the presence of low blood pressure without bacteria in the blood

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States