Study of 2% Chlorhexidine Gluconate-Impregnated Bath Cloths to Prevent MRSA Colonization in Complex Continuing Care

NCT01717690 | Completed Phase 4

• 1 other identifier: BCGC-CHG-2012
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether daily bathing with 2% chlorhexidine gluconate-impregnated antiseptic cleanser (CHG) significantly reduces incidence of colonization of hospitalized patients with methicillin-resistant Staphylococcus aureus (MRSA). Investigators postulate that daily bathing with CHG significantly reduces incidence of colonization of hospitalized patients with MRSA.

Conditions

Staph Aureus Methicillin Resistant Colonization

Keywords

MRSA; chlorhexidine

Outcome Measures

Primary Outcomes (1)

• Incidence of MRSA colonization

  Primary outcome measure will be incidence of MRSA colonization measured through bi-weekly point-prevalence surveys on each of the three units. All new admissions and re-admissions to the units will also be screened. Protective properties of CHG bathing are expected to significantly reduce the incidence of MRSA transmission in the intervention arm, compared to control arms.

  12 months

Secondary Outcomes (1)

• Time to MRSA conversion

  12 months

Study Arms (2)

CHG antiseptic body cleanser

ACTIVE COMPARATOR

One randomly selected intervention unit in Complex Continuing Care program where all patients (MRSA-positive and MRSA-negative) will be bathed daily with an antiseptic body cleanser (CHG). Only MRSA-negative patients at enrollment will be included in the study analysis, and only their outcomes (MRSA status and time to conversion) will be analyzed. Antiseptic body cleanser - 2% Chlorhexidine Gluconate in a non-alcohol and non-alkaline base, delivered to skin surface through the bath cloths impregnated with this antiseptic solution.

Drug: CHG antiseptic body cleanser

Non-antiseptic body cleanser

NO INTERVENTION

Two control units in Complex Continuing Care program where all patients (MRSA-positive and MRSA-negative) will be bathed daily with a non-antiseptic body cleanser (Comfort Bath ®). Only MRSA-negative patients at enrollment will be included in the study analysis, and only their outcomes (MRSA status and time to conversion) will be analyzed.

Interventions

CHG antiseptic body cleanser DRUG

The intervention consists of daily bathing of all patients (MRSA-positive and MRSA-negative) on the intervention unit with CHG.

Also known as: Chlorhexidine gluconate cloths, Drug Identification Number (Health Canada): 02245741

CHG antiseptic body cleanser

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• MRSA-negative (at enrollment) inpatient of Complex Continuing Care program

You may not qualify if:

• MRSA-positive (at enrollment) inpatient of Complex Continuing Care program

Sponsors & Collaborators

• Baycrest: lead

Study Sites (1)

Baycrest Hospital, Complex Continuing Care program

Toronto, Ontario, M6A 2E1, Canada

Location

Study Officials

• Chingiz Amirov, MPH, CIC

  Baycrest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Infection Prevention and Control

Study Record Dates

• First Submitted: October 26, 2012
• First Posted: October 30, 2012
• Study Start: August 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: February 23, 2015

Record last verified: 2015-02

Locations

CA (1)