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

Stem Cell Transplant Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03030989
• Other study ID #: IRB16-1059
• Status: Completed
• Phase: Phase 2
• Start date: January 2017
• Est. completion date: June 2019

Study information

• Verified date: November 2020
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2019
• Est. primary completion date: January 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infection
• Stem Cell Transplant Complications

Intervention

Drug:
• Chlorhexidine Gluconate 2% Wipe

• Placebo Wipe

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

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