Staph Aureus Methicillin Resistant Colonization Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT01208519 -
SATURN 04 Nosocomial Acquisition Study
|
N/A |