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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

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ClinicalTrials.gov Identifier: NCT03030989
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Stem Cell Transplant Complications Drug: Chlorhexidine Gluconate 2% Wipe Drug: Placebo Wipe Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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 Start Date : January 2017
Actual Primary Completion Date : January 2, 2019
Actual Study Completion Date : June 2019


Arm Intervention/treatment
Active Comparator: Chlorhexidine Gluconate 2% Wipe Drug: Chlorhexidine Gluconate 2% Wipe
Placebo Comparator: Placebo wipe Drug: Placebo Wipe



Primary Outcome Measures :
  1. Primary blood stream infections [ Time Frame: 14 weeks ]
  2. Clinical (culture-negative) sepsis [ Time Frame: 14 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03030989


Locations
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United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT03030989     History of Changes
Other Study ID Numbers: IRB16-1059
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents