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Chlorhexidine Bathing Effect on Clostridium Difficile Rates

Primary Purpose

Clostridium Difficile

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sage 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation
Sponsored by
Jared Brooks
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Clostridium Difficile focused on measuring Chlorhexidine bathing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Prescription of antibiotics for suspected or confirmed infection.
  • Admitted to the 2600 General/Medical ward at Delnor Hospital.

Exclusion Criteria:

  • Antibiotics only for surgical prophylaxis
  • Not mentally capable
  • Cannot provide consent in English
  • Pregnant
  • Documented chlorhexidine allergy
  • Patient is a prisoner
  • Health system employee

Sites / Locations

  • Northwestern Medicine - Delnor Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Interventional

Arm Description

Receive the bathing standard of care.

Receive daily bathing with 2% Chlorhexidine gluconate bathing wipes.

Outcomes

Primary Outcome Measures

Number of participants with Relative Risk of C-diff infection
Study data will cease to be collected after 300 participants have been enrolled or until 12 months have elapsed. Data will be collected and assessed monthly.
Duration of Hospital stays

Secondary Outcome Measures

Full Information

First Posted
July 14, 2015
Last Updated
July 6, 2016
Sponsor
Jared Brooks
Collaborators
Northwestern Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02502682
Brief Title
Chlorhexidine Bathing Effect on Clostridium Difficile Rates
Official Title
Effect of Daily Chlorhexidine Bathing on Clostridium Difficile Rates on the General Medical Floor in Patients Receiving Antibiotics
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jared Brooks
Collaborators
Northwestern Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Clostridium difficile (C. diff.) infections, whether nosocomial or community borne, may present with profound diarrhea, especially in those patients receiving antibiotics. Based on a preliminary review of hospital data, the investigators have found that these symptomatic c. diff infections occur with a relatively high incidence at Delnor Hospital. Notwithstanding their high mortality, one recent study attributes a near quadrupling of hospitalization costs to c. diff infections. Chlorhexidine baths have been shown in multiple randomized trials to help reduce the incidence of highly virulent pathogens and hospital acquired infections. Further, several studies show a favorable effect of reducing the incidence of c. diff infections by using Chlorhexidine baths on ICU patients. Far fewer studies, however, have focused on the effects of these baths on general medical/surgical wards. This investigation seeks to study the effect of the daily use of 2% Chlorhexidine gluconate wipes in patients on the general medical/surgical wards who are exposed to antibiotics for a suspected or confirmed infection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile
Keywords
Chlorhexidine bathing

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
167 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Receive the bathing standard of care.
Arm Title
Interventional
Arm Type
Experimental
Arm Description
Receive daily bathing with 2% Chlorhexidine gluconate bathing wipes.
Intervention Type
Drug
Intervention Name(s)
Sage 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation
Intervention Description
Daily bathing.
Primary Outcome Measure Information:
Title
Number of participants with Relative Risk of C-diff infection
Description
Study data will cease to be collected after 300 participants have been enrolled or until 12 months have elapsed. Data will be collected and assessed monthly.
Time Frame
up to 12 months
Title
Duration of Hospital stays
Time Frame
expected average of six days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Prescription of antibiotics for suspected or confirmed infection. Admitted to the 2600 General/Medical ward at Delnor Hospital. Exclusion Criteria: Antibiotics only for surgical prophylaxis Not mentally capable Cannot provide consent in English Pregnant Documented chlorhexidine allergy Patient is a prisoner Health system employee
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Poustinchian, D.O.
Organizational Affiliation
Hospitalist - Northwestern Medicine Regional Medical Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Medicine - Delnor Hospital
City
Geneva
State/Province
Illinois
ZIP/Postal Code
60134
Country
United States

12. IPD Sharing Statement

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Chlorhexidine Bathing Effect on Clostridium Difficile Rates

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