Chlorhexidine Bathing Effect on Clostridium Difficile Rates

Phase 2

Completed

• Conditions: Clostridium Difficile
• Interventions: Drug: Sage 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation

• Registration Number: NCT02502682
• Lead Sponsor: Jared Brooks

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-14
• Study First Submitted QC: 2015-07-17
• Study First Posted: 2015-07-20
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-06
• Last Update Posted: 2016-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional	Sage 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation	Receive daily bathing with 2% Chlorhexidine gluconate bathing wipes.

Primary Outcome Measures

Name	Time	Method
Number of participants with Relative Risk of C-diff infection	up to 12 months	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	expected average of six days

Trial Locations

Locations (1)

Northwestern Medicine - Delnor Hospital; 🇺🇸 Geneva, Illinois, United States