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

NCT ID: NCT01717690

Last Updated: 2015-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-09-30

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.

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.

Conditions

Staph Aureus Methicillin Resistant Colonization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

CHG antiseptic body cleanser

Intervention Type: DRUG

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CHG antiseptic body cleanser

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

Intervention Type: DRUG

Other Intervention Names

Chlorhexidine gluconate cloths; Drug Identification Number (Health Canada): 02245741

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Baycrest

OTHER

Sponsor Role: lead

Responsible Party

Chingiz Amirov

Director, Infection Prevention and Control

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chingiz Amirov, MPH, CIC

Role: PRINCIPAL_INVESTIGATOR

Baycrest

Locations

Baycrest Hospital, Complex Continuing Care program

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

BCGC-CHG-2012

Identifier Type: -

Identifier Source: org_study_id