Back to resultsA 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
Primary Purpose
Stem Cell Transplant Complications
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Chlorhexidine Gluconate 2% Wipe
Placebo Wipe
Sponsored by
About this trial
This is an interventional prevention trial for Stem Cell Transplant Complications
Eligibility Criteria
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
Sites / Locations
- University of Chicago
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Chlorhexidine Gluconate 2% Wipe
Placebo wipe
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants With Primary Blood Stream Infections
Blood stream infections are defined by the presence of bacteria in the blood
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03030989
First Posted
January 23, 2017
Last Updated
November 16, 2020
Sponsor
University of Chicago
1. Study Identification
Unique Protocol Identification Number
NCT03030989
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 2017 (undefined)
Primary Completion Date
January 2, 2019 (Actual)
Study Completion Date
June 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stem Cell Transplant Complications
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chlorhexidine Gluconate 2% Wipe
Arm Type
Active Comparator
Arm Title
Placebo wipe
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine Gluconate 2% Wipe
Intervention Type
Drug
Intervention Name(s)
Placebo Wipe
Primary Outcome Measure Information:
Title
Number of Participants With Primary Blood Stream Infections
Description
Blood stream infections are defined by the presence of bacteria in the blood
Time Frame
14 weeks
Title
Number of Participants With Clinical (Culture-negative) Sepsis
Description
Clinical (culture-negative) sepsis is defined by the presence of low blood pressure without bacteria in the blood
Time Frame
14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
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
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