Trial Outcomes & Findings for Checklist to Prevent MRSA Surgical Site Infections (NCT NCT02216227)
NCT ID: NCT02216227
Last Updated: 2026-03-31
Results Overview
Participants with superficial and deep/organ space MRSA infections, 90 days postoperatively, as measured by VA electronic health data.
COMPLETED
NA
23005 participants
90 days postoperatively
2026-03-31
Participant Flow
For the "Concurrent Non-equivalent Control Group" there were not patients identified in VA databases as undergoing total joint arthroplasty or cardiac surgery at VA Medical Centers who were not included in the intervention group during the years of the intervention.
Unit of analysis: VA Facilities
Participant milestones
| Measure |
Retrospective Control Group
Retrospective Control Group Inclusion Criteria: • Patients identified in VA databases (e.g. VASQIP) by ICD-9 procedure codes as undergoing total joint arthroplasty or cardiac surgery at the 11 intervention VA Medical Centers during the 5 year preintervention period (2008-2013)
|
Surgical Site Infection Checklist
At these VA Facilities, if patient has a known positive Staph aureus pre-op screening result (MRSA or MSSA):
* decolonize with intranasal Mupirocin ointment BID x 5 days
* chlorhexidine gluconate (CHG) bathing (daily x 5 days, using wipes or liquid)
* cefazolin plus Vancomycin (no Vanco for MSSA positive)
At these VA facilities, if patient has a known negative Staph aureus pre-op screening result:
* CHG bathing (night before \& morning of surgery using wipes or liquid)
* cefazolin
At these VA facilities, if patient was not screened or results are unknown at time of surgery:
* decolonize with intranasal Mupirocin ointment (start BID x 5 days; discontinue if negative screen)
* CHG bathing (start daily bath 5 days before operation if possible; at a minimum bathe the night before \& morning of surgery using wipes or liquid)
* cefazolin plus Vancomycin
Nasal Povidone Iodine: In 2017, an FDA final monograph stated that nasal povidone-iodine may be used for pre-surgical decolonization. Nasal povidone-iodine should be able to overcome barriers to checklist implementation that we identified in Aim 3. We now plan to replace the nasal agent mupirocin with the nasal agent povidone-iodine at 3 participating medical centers (Iowa City VA, Minneapolis VA and Portland VA) to assess whether this overcomes the barriers to our SSI checklist.
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|---|---|---|
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Retrospective Period
STARTED
|
15212 11
|
0 0
|
|
Retrospective Period
COMPLETED
|
15212 11
|
0 0
|
|
Retrospective Period
NOT COMPLETED
|
0 0
|
0 0
|
|
Intervention Period
STARTED
|
0 0
|
7793 11
|
|
Intervention Period
COMPLETED
|
0 0
|
7793 11
|
|
Intervention Period
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age data were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Surgical Site Infection Checklist
n=11 VA facilities
At these VA Facilities, if patient has a known positive Staph aureus pre-op screening result (MRSA or MSSA):
* decolonize with intranasal Mupirocin ointment BID x 5 days
* chlorhexidine gluconate (CHG) bathing (daily x 5 days, using wipes or liquid)
* cefazolin plus Vancomycin (no Vanco for MSSA positive)
At these VA facilities, if patient has a known negative Staph aureus pre-op screening result:
* CHG bathing (night before \& morning of surgery using wipes or liquid)
* cefazolin
At these VA facilities, if patient was not screened or results are unknown at time of surgery:
* decolonize with intranasal Mupirocin ointment (start BID x 5 days; discontinue if negative screen)
* CHG bathing (start daily bath 5 days before operation if possible; at a minimum bathe the night before \& morning of surgery using wipes or liquid)
* cefazolin plus Vancomycin
Nasal Povidone Iodine: replace mupirocin with povidone-iodine at 3 medical centers to assess if this overcomes the barriers to our SSI checklist.
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|---|---|
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Age, Categorical
<=18 years
|
0 VA facilities
Age data were not collected from any participant.
|
|
Age, Categorical
Between 18 and 65 years
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0 VA facilities
Age data were not collected from any participant.
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Age, Categorical
>=65 years
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0 VA facilities
Age data were not collected from any participant.
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|
Sex: Female, Male
Female
|
0 VA facilities
Sex data were not collected from any participant.
|
|
Sex: Female, Male
Male
|
0 VA facilities
Sex data were not collected from any participant.
|
|
Region of Enrollment
United States
|
7793 participants
n=7793 Participants
|
PRIMARY outcome
Timeframe: 90 days postoperativelyPopulation: Patients undergoing surgery at the 11 VA facilities during intervention
Participants with superficial and deep/organ space MRSA infections, 90 days postoperatively, as measured by VA electronic health data.
Outcome measures
| Measure |
Retrospective Control Group
n=11 VA facilities
Patients in preintervention time period prior to implementation of the Surgical Site Infection Checklist
|
Surgical Site Infection Checklist
n=11 VA facilities
At these VA Facilities, if patient has a known positive Staph aureus pre-op screening result (MRSA or MSSA):
* decolonize with intranasal Mupirocin ointment BID x 5 days
* chlorhexidine gluconate (CHG) bathing (daily x 5 days, using wipes or liquid)
* cefazolin plus Vancomycin (no Vanco for MSSA positive)
At these VA facilities, if patient has a known negative Staph aureus pre-op screening result:
* CHG bathing (night before \& morning of surgery using wipes or liquid)
* cefazolin
At these VA facilities, if patient was not screened or results are unknown at time of surgery:
* decolonize with intranasal Mupirocin ointment (start BID x 5 days; discontinue if negative screen)
* CHG bathing (start daily bath 5 days before operation if possible; at a minimum bathe the night before \& morning of surgery using wipes or liquid)
* cefazolin plus Vancomycin
Nasal Povidone Iodine: replace mupirocin with povidone-iodine at 3 medical centers to assess if this overcomes the barriers to our SSI checklist.
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|---|---|---|
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Participants With Superficial and Deep/Organ Space MRSA Infections Within 90 Days
|
70 participants
|
25 participants
|
SECONDARY outcome
Timeframe: one year postoperativelyPopulation: Patients undergoing surgeries at 11 VA facilities during intervention period; data reported is at 90 days
The investigators chose 90-days rather than 1 year for the primary outcome measure since not all patients in the study will be able to be followed for 1 year due to the timing of the study. However, since the investigators will be able to follow 83% of the cohort for 1-year post-operatively, the investigators will perform this secondary analysis in which the investigators will include only patients who were followed for one year. However, it is unlikely that the 90-day analysis and 1 year analysis will differ significantly because over 75% of SSIs are detected within 30 days, in fact most SSI manifest within 22 days.
Outcome measures
| Measure |
Retrospective Control Group
n=11 VA facilities
Patients in preintervention time period prior to implementation of the Surgical Site Infection Checklist
|
Surgical Site Infection Checklist
n=11 VA facilities
At these VA Facilities, if patient has a known positive Staph aureus pre-op screening result (MRSA or MSSA):
* decolonize with intranasal Mupirocin ointment BID x 5 days
* chlorhexidine gluconate (CHG) bathing (daily x 5 days, using wipes or liquid)
* cefazolin plus Vancomycin (no Vanco for MSSA positive)
At these VA facilities, if patient has a known negative Staph aureus pre-op screening result:
* CHG bathing (night before \& morning of surgery using wipes or liquid)
* cefazolin
At these VA facilities, if patient was not screened or results are unknown at time of surgery:
* decolonize with intranasal Mupirocin ointment (start BID x 5 days; discontinue if negative screen)
* CHG bathing (start daily bath 5 days before operation if possible; at a minimum bathe the night before \& morning of surgery using wipes or liquid)
* cefazolin plus Vancomycin
Nasal Povidone Iodine: replace mupirocin with povidone-iodine at 3 medical centers to assess if this overcomes the barriers to our SSI checklist.
|
|---|---|---|
|
Participants With Superficial and Deep/Organ Space MRSA Infections Within 1 Year
|
70 participants
|
25 participants
|
SECONDARY outcome
Timeframe: 30-days pre-surgery to day of surgeryPopulation: Because facilities did not collect this data, this measure was not conducted and data will not be collected in the future.
This will be established electronically, through measurement of mupirocin prescription, CHG prescription and swab collection, as well as utilizing the compliance information collected on patient intake on the day of surgery.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Duration of postoperative stay, an expected average of 3 daysPopulation: Due to funding constraints, this measure was not conducted and data will not be collected in the future.
Duration of postoperative stay, an expected average of 3 days.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1-year post-surgeryPopulation: Due to funding constraints, this measure was not conducted and data will not be collected in the future.
All-cause mortality, Up to 1-year post-surgery.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 90-days postsurgeryPopulation: Due to funding constraints, this measure was not conducted and data will not be collected in the future.
Readmission, 90-days postsurgery.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30-days pre-surgery to 90-days post-surgeryPopulation: Due to funding constraints, this measure was not conducted and data will not be collected in the future.
The investigators will test bacterial isolates from MRSA positive patients at the 11 interventions sites. The VA is mandated to take nasal swabs from each patient preoperatively. For those patients who are MRSA positive, the investigators will have the bacterial isolates sent to the Iowa City site to be tested for resistance to mupirocin and CHG. The investigators will also collect bacterial isolates from patients who experience surgical site infections during the study. These isolates will also be tested for mupirocin and CHG resistance. The purpose of this testing is to a) ensure the investigators' study checklist does not cause mupirocin or CHG resistance by b) determining if resistance was present at the initial nasal swab, or if resistance occurred after performance of study checklist.
Outcome measures
Outcome data not reported
Adverse Events
Surgical Site Infection Checklist
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Eli N Perencevich, MD MS BS
Iowa City VA Health Care System, Iowa City, IA
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place