S. Aureus Screening and Decolonization
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Hospital |
| Therapuetic Areas: | Immunology / Infectious Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/1/2018 |
| Start Date: | July 2014 |
| End Date: | August 2016 |
Effectiveness of Screening and Decolonization of S. Aureus in Surgery Outpatients
Staphylococcus aureus (SA) healthcare-associated infections (HAI) cause significant morbidity
and mortality. SA causes 15% of all HAI and 30% of surgical site infections (SSIs). Each year
over 40 million Americans undergo operations, 1-10% of whom will acquire SSIs. Such
infections double the length of hospitalization and risk of dying, and increase U.S. health
care costs by $5-10 billion/year. We need effective interventions to prevent SSIs caused by
either methicillin-susceptible (MSSA) or methicillin-resistant (MRSA) strains. Nasal carriers
of SA (25-30% of adults) have a 2-14 times greater risk than non-carriers of acquiring an SA
SSI. A potential prevention approach is routine pre-operative screening of patients, followed
by decolonization of identified SA carriers.
and mortality. SA causes 15% of all HAI and 30% of surgical site infections (SSIs). Each year
over 40 million Americans undergo operations, 1-10% of whom will acquire SSIs. Such
infections double the length of hospitalization and risk of dying, and increase U.S. health
care costs by $5-10 billion/year. We need effective interventions to prevent SSIs caused by
either methicillin-susceptible (MSSA) or methicillin-resistant (MRSA) strains. Nasal carriers
of SA (25-30% of adults) have a 2-14 times greater risk than non-carriers of acquiring an SA
SSI. A potential prevention approach is routine pre-operative screening of patients, followed
by decolonization of identified SA carriers.
The long term goal of this research is to help reduce the incidence of SSIs caused by SA,
both MSSA and MRSA strains. This will help improve the safety and effectiveness of health
care for Americans. Achievement of this goal requires that we first address the following
critical knowledge gaps: (i) which surgical patients should be screened pre-operatively; (ii)
which body site(s) should be screened for optimal SA detection, and (iii) which
decolonization approach is optimal for outpatient use. The goal of this study is to conduct
the research needed to determine pre-operative SA carriage rates (including by strain type
and site of carriage), to evaluate the practicality (adherence, cost) of a SA decolonization
protocol that is self-administered by patients at home. We are conducting randomized clinical
trial (RCT) of the efficacy of nasal mupirocin ointment, chlorhexidine gluconate (CHG) mouth
rinse, and CHG pre-operative bathing, as performed by the patient at home for 5 days
pre-operatively. This protocol will be compared with the current standard of care, usually
1-2 showers with an antiseptic soap before the procedure. Briefly, the aims are as follows:
Aim 1: Determine the efficacy of a novel decolonization protocol, compared with standard of
care, for eradicating SA carriage pre-operatively in surgery out-patients. We hypothesize
that the SA eradication rate will be 2-3 times higher in the intervention arm compared with
the standard of care arm.
Aim 2: Obtain data to inform sample size calculations and cost estimates for a future trial
to prevent SSIs, determine screening requirements, and assess treatment adherence. We will:
determine the proportion of pre-operative patients who are SA carriers and the sites of
carriage, by SA type, determine adherence to the study intervention and standard of care,
reasons for non-compliance, and gather cost data to provide preliminary evidence of potential
cost-effectiveness of the intervention.
Aim 3: Identify risk factors (demographic, medical) for SA carriage. Gather preliminary data
on SSIs in study subjects.
both MSSA and MRSA strains. This will help improve the safety and effectiveness of health
care for Americans. Achievement of this goal requires that we first address the following
critical knowledge gaps: (i) which surgical patients should be screened pre-operatively; (ii)
which body site(s) should be screened for optimal SA detection, and (iii) which
decolonization approach is optimal for outpatient use. The goal of this study is to conduct
the research needed to determine pre-operative SA carriage rates (including by strain type
and site of carriage), to evaluate the practicality (adherence, cost) of a SA decolonization
protocol that is self-administered by patients at home. We are conducting randomized clinical
trial (RCT) of the efficacy of nasal mupirocin ointment, chlorhexidine gluconate (CHG) mouth
rinse, and CHG pre-operative bathing, as performed by the patient at home for 5 days
pre-operatively. This protocol will be compared with the current standard of care, usually
1-2 showers with an antiseptic soap before the procedure. Briefly, the aims are as follows:
Aim 1: Determine the efficacy of a novel decolonization protocol, compared with standard of
care, for eradicating SA carriage pre-operatively in surgery out-patients. We hypothesize
that the SA eradication rate will be 2-3 times higher in the intervention arm compared with
the standard of care arm.
Aim 2: Obtain data to inform sample size calculations and cost estimates for a future trial
to prevent SSIs, determine screening requirements, and assess treatment adherence. We will:
determine the proportion of pre-operative patients who are SA carriers and the sites of
carriage, by SA type, determine adherence to the study intervention and standard of care,
reasons for non-compliance, and gather cost data to provide preliminary evidence of potential
cost-effectiveness of the intervention.
Aim 3: Identify risk factors (demographic, medical) for SA carriage. Gather preliminary data
on SSIs in study subjects.
Inclusion Criteria:
- All patient who are 18 years and older, able to give informed consent and willing to
complete the study decolonization protocol.
- Surgery must be scheduled 2 weeks in the future to allow completion of the study
protocol prior to the scheduled operation.
- Patients will be admitted from home the day of the surgery or have the surgery done on
an outpatient basis.
Exclusion Criteria:
- Currently on antibiotic therapy, allergy to mupirocin or CHG.
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