Trial record 11 of 42 for:    Open Studies | "Staphylococcal Infections"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Baycrest
Sponsor:
Information provided by (Responsible Party):
Chingiz Amirov, Baycrest
ClinicalTrials.gov Identifier:
NCT01717690
First received: October 26, 2012
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Staph Aureus Methicillin Resistant Colonization
Drug: CHG antiseptic body cleanser
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomized Controlled Clinical Trial of 2% Chlorhexidine Gluconate-Impregnated Bath Cloths to Prevent MRSA Colonization on Complex Continuing Care Units of Baycrest Hospital

Resource links provided by NLM:


Further study details as provided by Baycrest:

Primary Outcome Measures:
  • Incidence of MRSA colonization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Time to MRSA conversion [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Secondary outcome measure will be time to MRSA conversion measured as the length of time it takes patients to convert from being MRSA-negative at enrollment to MRSA-positive at discharge or end of the study. Protective properties of CHG bathing are expected to significantly prolong conversion time.


Estimated Enrollment: 70
Study Start Date: August 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CHG antiseptic body cleanser

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
The intervention consists of daily bathing of all patients (MRSA-positive and MRSA-negative) on the intervention unit with CHG.
Other Names:
  • Chlorhexidine gluconate cloths
  • Drug Identification Number (Health Canada): 02245741
No Intervention: Non-antiseptic body cleanser

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.


Detailed Description:

Bathing patients with 2% chlorhexidine gluconate-impregnated cloths (CHG) is an established practice at Baycrest. Our previous studies have demonstrated strong MRSA-preventive properties of CHG bathing practice - the rate of MRSA transmission on intervention units dropped from 4.99 to 0.88 cases per 1,000 patient days - an overall rate reduction of 82%.

Although CHG will continue to be used as part of an established clinical practice in our hospital, its impact on MRSA prevention merits further evaluation in complex continuing care (CCC) settings endemic for MRSA. Investigators propose a cluster-randomized, prospective, open-label, two-arm clinical trial (RCT) on three geographically separate, but otherwise comparable, CCC units - one intervention unit using CHG, and two control units using non-antiseptic cleanser. The RCT is expected to conclusively answer whether daily bathing with CHG significantly reduces incidence of MRSA colonization.

By cluster randomization investigators imply randomly assigning interventions to the three patient care units. Investigators propose randomization of the units as it is not feasible to randomly assign the individual participants to intervention vs control arms.

For a meaningful interpretation of the RCT findings, patient populations on the three floors will be compared at the beginning, during, and at the end of the study. The following variables will be used to compare patient populations:

  • Colonization pressure (CP) is a measure of the MRSA reservoir on the unit. CP will be calculated at the onset of the RCT and then bi-weekly (Number of MRSA patient-days × 100 ÷ Total Number of Patient Days).
  • Average Braden scale score (BSS) for patients on each unit is measured to predict a pressure ulcer risk. It is one of the measures of patient's clinical complexity. It is calculated by examining six patient criteria (sensory perception, skin moisture, physical activity, mobility, nutrition, friction and shear). BSS will be calculated at the onset of the RCT and then monthly.
  • Average Case Mix Index (CMI) is a value reflecting the daily relative weight of resources used by an individual patient compared to a base resource level (the average resource use of the patient population). The CMI value is not a dollar amount; rather it is a relative value and an indirect marker of patient's clinical complexity. CMI will be calculated at the onset of the RCT and then quarterly.

Patient information will be de-identified for privacy reasons, before analysis of the study data - logistic regression, to compare the rates of MRSA incidence and time to MRSA conversion on intervention and control units.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • MRSA-positive (at enrollment) inpatient of Complex Continuing Care program
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01717690

Contacts
Contact: Chingiz M Amirov, MPH, CIC (1)-416-785-2500 ext 2981 camirov@baycrest.org
Contact: Heather L Candon, MSc, CIC (1)-416-785-2500 ext 2133 hcandon@baycrest.org

Locations
Canada, Ontario
Baycrest Hospital, Complex Continuing Care program Recruiting
Toronto, Ontario, Canada, M6A 2E1
Contact: Chingiz Amirov, MPH    (1)-416-785-2500 ext 2981    camirov@baycrest.org   
Contact: Heather L Candon, MSc    (1)-416-785-2500 ext 2133    hcandon@baycrest.org   
Principal Investigator: Chingiz Amirov, MPH, CIC         
Sponsors and Collaborators
Baycrest
Investigators
Principal Investigator: Chingiz Amirov, MPH, CIC Baycrest
  More Information

No publications provided

Responsible Party: Chingiz Amirov, Director, Infection Prevention and Control, Baycrest
ClinicalTrials.gov Identifier: NCT01717690     History of Changes
Other Study ID Numbers: BCGC-CHG-2012
Study First Received: October 26, 2012
Last Updated: March 3, 2014
Health Authority: Canada: Health Canada

Keywords provided by Baycrest:
MRSA
chlorhexidine

Additional relevant MeSH terms:
Chlorhexidine gluconate
Chlorhexidine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents
Disinfectants

ClinicalTrials.gov processed this record on October 01, 2014