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CompletedNCT02502682Updated Jul 11, 2016

Chlorhexidine Bathing Effect on Clostridium Difficile Rates

A Phase 2 interventional study of Sage 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation in Clostridium Difficile, sponsored by Jared Brooks. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-11.

Sponsored by Jared Brooks · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
167
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Clostridium Difficile

Keywords

  • Chlorhexidine bathing
03

In context

Clostridium Infections

310 studies on the registry are indexed under Clostridium Infections; 50 are open to participants now.

This study's enrollment of 167 is above the median of 65 across 233 interventional studies indexed under Clostridium Infections.

Browse Clostridium Infections studies →

Lead sponsor

This is the only study on the registry with Jared Brooks as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
167 participants (actual)

Study arms

  • No intervention
    Control

    Receive the bathing standard of care.

  • Experimental
    Interventional

    Receive daily bathing with 2% Chlorhexidine gluconate bathing wipes.

    Drug: Sage 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation

Interventions

  • DrugSage 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation

    Daily bathing.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: up to 12 months

  2. Duration of Hospital stays

    Time frame: expected average of six days

07

Study locations

1 site
  • Northwestern Medicine - Delnor Hospital
    Geneva, Illinois 60134, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02502682
Lead sponsor
Jared Brooks
Collaborators
Northwestern Medicine
Responsible party
Jared Brooks (Co-Investigator, Northwestern Medicine) — Sponsor-investigator
First posted
Jul 20, 2015
Start date
Jul 2015
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Jul 11, 2016

Study contacts

Brian Poustinchian, D.O.
principal investigator · Hospitalist - Northwestern Medicine Regional Medical Group

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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