Chlorhexidine Bathing Effect on Clostridium Difficile Rates

NCT ID: NCT02502682

Last Updated: 2016-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

167 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Clostridium Difficile

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control

Receive the bathing standard of care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventional

Receive daily bathing with 2% Chlorhexidine gluconate bathing wipes.

Group Type EXPERIMENTAL

Sage 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation

Intervention Type DRUG

Daily bathing.

Interventions

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Sage 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation

Daily bathing.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern Medicine

OTHER

Sponsor Role collaborator

Jared Brooks

OTHER

Sponsor Role lead

Responsible Party

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Jared Brooks

Co-Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Brian Poustinchian, D.O.

Role: PRINCIPAL_INVESTIGATOR

Hospitalist - Northwestern Medicine Regional Medical Group

Locations

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Northwestern Medicine - Delnor Hospital

Geneva, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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CDiff070115

Identifier Type: -

Identifier Source: org_study_id

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