1. Surgical Site Infection Prevention The Cardiovascular Surgical Translational Study (“CSTS”)
Armstrong Institute for Patient Safety and Quality
Elizabeth Martinez, MD, MHS

2. Armstrong Institute for Patient Safety and Quality
Learning Objectives
To understand the evidence based practices for SSI reduction
To understand the model for translating evidence into practice
To explore how to implement evidence-based behaviors to prevent SSI
To understand strategies to engage, educate, execute and evaluate
9/21/2011
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3. Proportion of Adverse Events Most Frequent Categories
Non-surgical
Surgical
Brennan. N Engl J Med. 1991;324:
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Introduction
Over 300,000 CABG annually
SSI rates 3.51% (10,500 annually)
25% mediastinitis
33% saphenous vein site
6.8% multiple sites
Increased mortality:17.3% v. 3.0% (p<0.0001)
Increased LOS: 47% v 5.9% with LOS>14days (p<0.0001)
Increased cost: $20,000 to $60,000
Fowler et al.Circ, 2005:112(S), 358.
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CABG SSI Risk Model*
Preop
Age
Obesity
Diabetes
Cardiogenic shock
Hemodialysis
Immunosuppression
Intraop
Perfusion time
Placement of IABP
≥ 3 anastomoses
*Did not include known best practices (e.g. SCIP)
Fowler et al.Circ, 2005:112(S), 358.
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6. Traditional SSI Risk Factors Intrinsic-Patient Related
Age
Nutritional status
Diabetes
Smoking
Obesity
Remote infections
Endogenous mucosal microorganisms
Altered immune system
Preoperative stay-severity of illness
Wound class
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Preventive Measures*
Appropriate hair removal
Appropriate prophylactic antibiotic use
Selection, timing, redosing**, discontinuation
Perioperative normothermia
Perioperative normoglycemia
*Surgical Care Improvement Metrics
**Proposed SCIP measure
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8. CDC Guidelines for Antibiotic Prophylaxis
1. The procedure should carry a significant risk of infection and/or cause significant bacterial contamination.
There are 3 SCIP measures for the appropriate use of prophylactic antibiotics.
These are:
Prophylactic abx received within 1 hour prior to incision,
Appropriate abx selection,
Discontinuation of abx within 24 hours after surgery end time.
The Guidelines to evaluate and follow when implementing a local, evidence-based practice for these choices include that (1) –The procedure should carry a significant risk of infection and/or cause significant bacterial contamination. For example, there are no evidence based guidelines to suggest that prophylactic abx are indicated for tonsillectomy or urethral dilatation if the urine is sterile. However – most of the teams involved today are following procedures in which prophylactic abx are indicated.
Mangram. Infect.Control Hosp.Epidemiol. 1999;20(4):250
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9. Relative Benefit from Antibiotic Surgical Prophylaxis
Operation
Prophylaxis (%)
Placebo (%)
NNT*
Colon
4-12
24-48
3-5
Other (mixed) GI
4-6
15-29
4-9
Vascular
1-4
7-17
10-17
Cardiac
3-9
44-49
2-3
Hysterectomy
1-16
18-38
3-6
Craniotomy
0.5-3
9-29
Total joint
0.5-1
2-9
12-100
Breast & hernia ops
3.5
5.2 58
This is a summary slide – showing the difference in the infection rate for various procedures and the number needed to receive the appropriate abx at the appropriative time to prevent on SSI. The differences in the NNT reflect the degree of risk of contamination.
The number needed to treat (NNT) is an epidemiological measure used in assessing the effectiveness of a health-care intervention, typically a treatment with medication. The NNT is the number of patients who need to be treated in order to prevent one additional bad outcome (i.e. to reduce the expected number of cases of a defined endpoint by one). It is defined as the inverse of the absolute risk reduction
* Number Needed to Treat
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10. CDC Guidelines for Antibiotic Prophylaxis
2. The antibiotic selected must be active against the major contaminating organisms and should have previously been shown to be effective prophylaxis. It is NOT necessary to cover ALL organisms present.
The next principle to keep in mind as local Guidelines are utilized is that
The antibiotic selected must be active against the major contaminating organisms and should have previously been shown to be effective prophylaxis.
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11. WOUND INFECTION: ORGANISMS 1990-1996
Staphylococci and Streptococci are the most common organisms of concern for most procedures, whereas anaerobes and Enterobacteriaceae are common for GI cases. Many published guidelines for AMP [5,6,11-15] are available for development of local antibiotic guidelines; local sensitivity profiles also should be taken into account.
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12. CDC Guidelines for Antibiotic Prophylaxis
3. The antibiotic chosen must achieve concentrations higher than the minimal inhibitory concentration (MIC) of the suspected pathogens in the wound site at the time of incision.
Unpublished data with cefazolin is adequate for average MIC within 3 minutes – Consideration must be made when a tourniquet is used – that the abx is administered prior to tourniquet inflation. Also – while there are mixed data on whether the infusion, of say vanc or clindaymicin needs to be completed prior to incision – most experts would advocate completion to make certain there are adequate levels. Of course – the goal should be avoidance of these except only with true pcn allergies – which is essentially in those patient with hives of previous anaphylaxis with exposure to a penicillin.
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13. Give antibiotics within 60 minutes prior to incision.
Relative Risk
Antibiotic levels of the individual agents must be higher than the MIC at the time of incision
Individual agents must be considered
Cefazolin has a Vd of L can can be pushed within minutes of incision
Additional doses dependent on half-life and blood loss
We have clinical data. Classen et al reported findings on 2847 patients investigating the timing of prophylactic antibiotics and surgical wound infections. In this study of patients undergoing clean or clean-contaminated surgery were prospectively monitored for antibiotic timing and incidence of SSI. This slide summarizes the results of that study showing that if antibiotics were not given in the preop time period defined as minutes – the relative risk of infection ranged from 2.4 x baseline if given after incision, and 5.8 to 6.7 times the risk if given too early or postoperatively.
Classen. NEJM. 1992;328:281.
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14. Cardiac surgery prophylaxis effect of serum levels
Serum Level at Wound Closure
Infection
None
Present
3/11 (27%)
2/175 (1%)
Observational studies have shown that repeated intraoperative dosing of an antibiotic with a short half-life is associated with a decreased risk of SSI.
P = .002
Goldmann. J Thorac Cardiovasc Surg. 1977;73:
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Cefazolin Half-life
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16. CDC Guidelines for Antibiotic Prophylaxis
4. The shortest possible course of the most effective least toxic antibiotic must be used for prophylaxis. Must consider distribution and half-life of individual agents.
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17. Does prolonged peri-op abx prophylaxis have consequences?
Prospective surveillance
2641 patients undergoing cardiac surgery
Exposure outcome:
cephalosporin resistant enterobacteriaceae and VRE
Prolonged antibiotic prophylaxis (>48 h)
increase the risk of acquired resistance
(OR 1.6, CI )
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18. CDC Guidelines for Antibiotic Prophylaxis
5. The newer broader spectrum agents must be saved for therapy of resistant organisms and should not be used for prophylaxis.
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19. Antimicrobial Prophylaxis: Category IB Evidence
Do not routinely use vancomycin for antimicrobial prophylaxis
IT IS NOT THE BEST AGENT FOR SKIN FLORA!
If Vancomycin is used
“it is recommended that an aminoglycoside be considered for one preoperative and at most one additional postoperative dose to act as a specific gram-negative agent when vancomycin is indicated to be the primary prophylactic agent.”1
This may not be commonly used but should be considered if you have a problem with gram negative infections.
1Ann Thorac Surg 2007;83:1569–76
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20. Hyperglycemia and Infection Risk: Abdominal and Cardiovascular Operations
Glucose POD#1
<220 mg%
>220 mg%
Any Infection
12%
31%
“Serious” Infection
5.7-fold increase for any glucose > 220 mg%
Glycemic control in the perioperative care of surgery is beginning to gain momentum. The predominance of the data are in cardiac and critical care patients. There are also compelling animal and lab data to support the impact of normoglycemia on infection and wound healing.
Pomposelli et all followed 100 diabetic patients undergoing abdominal and CV surgery and showed the glycemic control early in the postop course decreased patients risk.
Pomposelli. JPEN 1998;22:77
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21. Portland Diabetes Project: Mortality
CII 10 8 6 4
Mortality (%) 87 88 89 90 91 92 93 94 98 99 00
Year
Patients with diabetes
Patients without
diabetes 2 95 96 97 01
Portland Diabetic Project: Mortality
All patients with diabetes undergoing CABG (N = 3,554) were treated aggressively with either subcutaneous insulin (1987–1991) or continuous insulin infusion (1992–2001) for hyperglycemia in this nonrandomized, prospective study.
Observed mortality and glucose control were both significantly better with continuous insulin infusion than with subcutaneous insulin therapy.
Continuous insulin infusion independently reduced perioperative absolute mortality by 57% and risk-adjusted mortality by 50%. Improved survival was attributed to a reduction in cardiac-related deaths.
Furnary AP, Gao G, Grunkemeier GL, et al. Continuous insulin infusion reduces mortality in patients with diabetes undergoing coronary artery bypass grafting. J Thorac Cardiovasc Surg. 2003;125:1007–1021.
Eliminating the diabetic disadvantage.
Furnary AP, et al. J Thorac Cardiovasc Surg. 2003;125
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22. ADDITIONAL CONSIDERATIONS FOR REDUCING SSI
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23. Chlorhexidine is Beneficial as Surgical Skin Prep
Br J Surg Nov;97(11):
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24. Selective Nasal Decolonization
Bode. N Engl J Med 2010;362:9-17
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Nasal Decolonization
Selective decolonization
Rapid PCR
Patients with S. aureus
Protocol used Mupirocin PLUS chlorhexidine baths
The duration of the study treatment was 5 days, irrespective of the timing of any interventions. Patients who were still hospitalized after 3 weeks and those still hospitalized after 6 weeks received a second and third course of the same trial medication, respectively.
Bode. N Engl J Med 2010;362:9-17
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26. Mupirocin Recommendations
STS recommendations
“beginning at least the day before operation (sooner, if elective operation) and continuing for 2 to 5 days after surgery.” 1
CSTS recommendations
Selective decolonization
1Ann Thorac Surg 2007;83:1569–76
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27. Preoperative Chlorhexidine Baths
Mixed data
Do demonstrate decrease in skin colony count
Little data including cardiac surgical patients
Consider as part of a comprehensive program
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28. Estimated Overall Benefits1
Process
Relative Risk Reduction
NNT*
Clipping vs. Shaving
70% 21
Normothermia
68% 8
Appropriate Abx timing
80% 42
Glycemic control*
63% 31
*Number Needed to Treat
**Post op cardiac and Abd
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29. Summary Recommendations
First line antibiotic Cefazolin 2 grams to be given within 60 minutes prior to incision
Cefazolin to be redosed within 4 hours
Consider 2-3 hours
Perioperative antibiotics to be discontinued prior to 48 hours
Use a clipper to remove hair; remove the least area as possible
Maintain glucoses in the range and prevent hyperglycemia >200mg/dL
Chlorhexidine for skin prep
Selective decolonization
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30. Armstrong Institute for Patient Safety and Quality
Learning Objectives
To understand the evidence based practices for SSI reduction
To understand the model for translating evidence into practice
To explore how to implement evidence-based behaviors to prevent SSI
To understand strategies to engage, educate, execute and evaluate
1/16/2019
Armstrong Institute for Patient Safety and Quality

31. Translating Evidence into Practice
Pronovost, Berenholtz, Needham. BMJ 2008
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32. Your Hospitals’ Performance*
*summarized (estimate) data for all surgical procedures
from all participating Institutions as of 3/31/2011
Accessed 3/5/2011
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33. Ensure Patients Reliably Receive Evidence
Senior
Team
Staff
leaders
Engage
How does this make the world a better place?
Educate
What do we need to do?
Execute
What keeps me from doing it?
How can we do it with my resources and culture?
Evaluate
How do we know we improved safety?
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34. Armstrong Institute for Patient Safety and Quality
Engage
Make the problem real
Share local infection rates
Share local compliance with process measures
Share a story of a patient with SSI
Have the patient share their story
Publicly commit that harm is untenable
Institutional commitment
Champions within the OR and the ICU and floor teams
Partnership with Infection Preventionist
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Educate
Develop an educational plan to reach ALL members of the caregiver team
Educate on the evidence based practices AND the data collection plan and other steps of the process.
Use multiple methods to educate
Posters to educate the teams about the evidence-based process measure
Presentations at staff/faculty meetings, M&M
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36. Six Steps to Prevent SSI1.
Avoid Razors 2.
Avoid Hypothermia
>36 degrees 3.
Give Correct Antibiotics 4.
Give Antibiotics at the Right Time
*Within 60 minutes prior to incision 5.
Redose Antibiotics Appropriately 6.
Antibiotics at 24 Hours
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37. Perioperative SSI Process Measures
Quality Indicator
Numerator
Denominator
Appropriate antibiotic choice
Number of patients who received the appropriate prophylactic antibiotic
All patients for whom prophylactic antibiotics are indicated
Appropriate timing of prophylactic antibiotics
Number of patients who received the prophylactic antibiotic within 60 minutes prior to incision
Appropriate discontinuation of antibiotics
Number of patients who received prophylactic antibiotics and had them discontinued in 24 hours
All patients who received prophylactic antibiotics
Appropriate hair removal
Number of patients who did not have hair removed or who had hair removed with clippers
All surgical patients
Perioperative normothermia
Number of patients with postoperative temperature ≥36.0oC
Patients undergoing surgery without CPB/planned hypothermia
Perioperative glycemic control
Number of cardiac surgery patients with glucose control at 6AM pod 1 and 2
Patients undergoing cardiac surgery
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Execute
Culture
Develop a culture of intolerance for infection
Standardize/Reduce complexity of the process
Checklists -Confirm abx administration during briefing
Utilize a glycemic control protocol
Local antibiotic guidelines posted in ORs
Standardize surgical skin prep
Redundancy
Add best practices to briefing/debriefing checklist
Post reminders in the OR (White board)
Antibiotic timer program for redosing
Regular team meetings
Develop a project plan
Identify barriers
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Evaluate
Track compliance with SCIP measures
Performance measures already being tracked by hospitals as part of SCIP participation*
Post performance on monthly basis
Post in the OR, ICU and floor
Investigate non-compliant cases on a monthly basis
Use Learning from Defect (LFD) tool
Post SSI rates on a monthly/quarterly basis
Investigate each SSI with the CUSP team to identify areas for improvement using the LFD tool
Audit performance with skin prep methodology (at a minimum) and goal is conversion to chlorhexidine
There are data from all participating hospitals on hospital compare and SCIP is very highly penetrated nationally so we do not anticipate additional data collection burden for the evidence-based practices (SCIP infection measures). Check with your hospital QI/QA leaders to confirm tracking of these measures for cardiac surgery and brainstorm how to present these data these data locally. The goal is leverage current data collection burden for the teams.
*based on data availability on Hospital compare
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Share Results
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41. Armstrong Institute for Patient Safety and Quality
Acknowledgements
Deborah Hobson, BSN
Pamela Lipsett, MD
Sara Cosgrove, MD
Lisa Maragakis, MD
Trish Perl, MD
Matthew Huddle, BS
Nicole Errett, BS
Justin Henneman, BS
Joyce Wahr, MD
The Johns Hopkins SSI Prevention Collaborative teams
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42. QUESTIONS? Thank you! Elizabeth Martinez, MD, MHS
Massachusetts General Hospital, Harvard Medical School