Surgical Site Infection Prevention The Cardiovascular Surgical Translational Study (CSTS)

Armstrong Institute for Patient Safety and Quality

Elizabeth Martinez, MD, MHSmartinez.elizabeth@mgh.harvard.edu

Armstrong Institute for Patient Safety and Quality

Learning ObjectivesTo 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

9/21/2011Armstrong Institute for Patient Safety and Quality*

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Proportion of Adverse EventsMost Frequent Categories*Armstrong Institute for Patient Safety and Quality*Brennan. N Engl J Med. 1991;324:370-376Non-surgicalSurgical

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Chart1

0.194

0.136

0.129

0.106

0.081

0.075

0.07

0.07

Sheet1

Drug-relatedWound infect.Tech. comp.Late comp.Diag. mishapTherap. mishapNontech. comp.Proc. related

19.40%13.60%12.90%10.60%8.10%7.50%7.00%7.00%

IntroductionOver 300,000 CABG annuallySSI rates 3.51% (10,500 annually)25% mediastinitis33% saphenous vein site6.8% multiple sitesIncreased mortality:17.3% v. 3.0% (p14days (p

CABG SSI Risk Model*PreopAgeObesityDiabetesCardiogenic shockHemodialysisImmunosuppression

IntraopPerfusion timePlacement of IABP 3 anastomoses

*Armstrong Institute for Patient Safety and Quality**Did not include known best practices (e.g. SCIP)Fowler et al.Circ, 2005:112(S), 358.

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Traditional SSI Risk FactorsIntrinsic-Patient RelatedAgeNutritional statusDiabetesSmokingObesityRemote infectionsEndogenous mucosal microorganismsAltered immune systemPreoperative stay-severity of illnessWound class

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Preventive Measures*Appropriate hair removalAppropriate prophylactic antibiotic useSelection, timing, redosing**, discontinuationPerioperative normothermiaPerioperative normoglycemia

*Armstrong Institute for Patient Safety and Quality**Surgical Care Improvement Metrics**Proposed SCIP measure

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CDC Guidelines for Antibiotic Prophylaxis

1. The procedure should carry a significant risk of infection and/or cause significant bacterial contamination.

*Armstrong Institute for Patient Safety and Quality*Mangram. Infect.Control Hosp.Epidemiol. 1999;20(4):250

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Relative Benefit from Antibiotic Surgical Prophylaxis*Armstrong Institute for Patient Safety and Quality** Number Needed to Treat

OperationProphylaxis (%)Placebo (%)NNT*Colon4-1224-483-5Other (mixed) GI4-615-294-9Vascular1-47-1710-17Cardiac3-944-492-3Hysterectomy1-1618-383-6Craniotomy0.5-34-129-29Total joint0.5-12-912-100Breast & hernia ops3.55.258

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CDC Guidelines for Antibiotic Prophylaxis2. 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.

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WOUND INFECTION:ORGANISMS 1990-1996*Armstrong Institute for Patient Safety and Quality*

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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.

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Give antibiotics within 60 minutes prior to incision.*Armstrong Institute for Patient Safety and Quality*Relative RiskClassen. NEJM. 1992;328:281.

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Cardiac surgery prophylaxiseffect of serum levels*Armstrong Institute for Patient Safety and Quality*NonePresent3/11 (27%)2/175 (1%)Serum Level at Wound ClosureInfectionGoldmann. J Thorac Cardiovasc Surg. 1977;73:470-479.P = .002

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Cefazolin Half-life*Armstrong Institute for Patient Safety and Quality*

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CDC Guidelines for Antibiotic Prophylaxis4. 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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Does prolonged peri-op abx prophylaxis have consequences?Prospective surveillance 2641 patients undergoing cardiac surgeryExposure outcome: cephalosporin resistant enterobacteriaceae and VREProlonged antibiotic prophylaxis (>48 h) increase the risk of acquired resistance (OR 1.6, CI 1.1-2.6)

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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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Antimicrobial Prophylaxis: Category IB EvidenceDo not routinely use vancomycin for antimicrobial prophylaxisIT IS NOT THE BEST AGENT FOR SKIN FLORA!If Vancomycin is usedit 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.1This may not be commonly used but should be considered if you have a problem with gram negative infections.

*Armstrong Institute for Patient Safety and Quality*1Ann Thorac Surg 2007;83:156976

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Hyperglycemia and Infection Risk:Abdominal and Cardiovascular Operations*Armstrong Institute for Patient Safety and Quality*Pomposelli. JPEN 1998;22:77

Glucose POD#1220 mg%Any Infection12%31%Serious Infection5.7-fold increase for any glucose > 220 mg%

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Portland Diabetes Project: Mortality*Armstrong Institute for Patient Safety and Quality*Furnary AP, et al. J Thorac Cardiovasc Surg. 2003;125

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ADDITIONAL CONSIDERATIONS FOR REDUCING SSI*Armstrong Institute for Patient Safety and Quality*

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Chlorhexidine is Beneficial asSurgical Skin Prep*Armstrong Institute for Patient Safety and Quality*Br J Surg. 2010 Nov;97(11):1614-20

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Selective Nasal Decolonization*Armstrong Institute for Patient Safety and Quality*Bode. N Engl J Med 2010;362:9-17

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Nasal DecolonizationSelective decolonizationRapid PCRPatients with S. aureusProtocol used Mupirocin PLUS chlorhexidine bathsThe 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.

*Armstrong Institute for Patient Safety and Quality*Bode. N Engl J Med 2010;362:9-17

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Mupirocin RecommendationsSTS recommendationsbeginning at least the day before operation (sooner, if elective operation) and continuing for 2 to 5 days after surgery. 1

CSTS recommendationsSelective decolonization

*Armstrong Institute for Patient Safety and Quality*1Ann Thorac Surg 2007;83:156976

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Preoperative Chlorhexidine BathsMixed dataDo demonstrate decrease in skin colony countLittle data including cardiac surgical patientsConsider as part of a comprehensive program

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Estimated Overall Benefits1*Armstrong Institute for Patient Safety and Quality**Number Needed to Treat**Post op cardiac and Abd

ProcessRelative Risk ReductionNNT*Clipping vs. Shaving70% 21Normothermia 68%8Appropriate Abx timing 80%42Glycemic control* 63% 31

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Summary RecommendationsFirst line antibiotic Cefazolin 2 grams to be given within 60 minutes prior to incisionCefazolin to be redosed within 4 hoursConsider 2-3 hoursPerioperative antibiotics to be discontinued prior to 48 hoursUse a clipper to remove hair; remove the least area as possibleMaintain glucoses in the 140-180 range and prevent hyperglycemia >200mg/dLChlorhexidine for skin prepSelective decolonization

*Armstrong Institute for Patient Safety and Quality*

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Learning ObjectivesTo 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

*Armstrong Institute for Patient Safety and Quality*

Armstrong Institute for Patient Safety and Quality

Translating Evidenceinto Practice*Armstrong Institute for Patient Safety and Quality*Pronovost, Berenholtz, Needham. BMJ 2008

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Your Hospitals Performance**Armstrong Institute for Patient Safety and Quality**summarized (estimate) data for all surgical procedures from all participating Institutions as of 3/31/2011www.hospitalcompare.hhs.gov;Accessed 3/5/2011

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Ensure Patients ReliablyReceive Evidence*Armstrong Institute for Patient Safety and Quality*

SeniorTeamStaffleadersleadersEngageHow does this make the world a better place?EducateWhat do we need to do?ExecuteWhat keeps me from doing it?How can we do it with my resources and culture?EvaluateHow do we know we improved safety?

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EngageMake the problem realShare local infection ratesShare local compliance with process measuresShare a story of a patient with SSIHave the patient share their story

Publicly commit that harm is untenableInstitutional commitmentChampions within the OR and the ICU and floor teamsPartnership with Infection Preventionist

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EducateDevelop 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 educatePosters to educate the teams about the evidence-based process measurePresentations at staff/faculty meetings, M&M

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**Avoid RazorsAvoid HypothermiaGive Correct AntibioticsGive Antibiotics at the Right Time Redose Antibiotics AppropriatelyAntibiotics at 24 Hours*Within 60 minutes prior to incision

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Perioperative SSI Process Measures*Armstrong Institute for Patient Safety and Quality*

Quality IndicatorNumeratorDenominatorAppropriate antibiotic choiceNumber of patients who received the appropriate prophylactic antibioticAll patients for whom prophylactic antibiotics are indicatedAppropriate timing of prophylactic antibioticsNumber of patients who received the prophylactic antibiotic within 60 minutes prior to incisionAll patients for whom prophylactic antibiotics are indicatedAppropriate discontinuation of antibioticsNumber of patients who received prophylactic antibiotics and had them discontinued in 24 hoursAll patients who received prophylactic antibioticsAppropriate hair removalNumber of patients who did not have hair removed or who had hair removed with clippersAll surgical patientsPerioperative normothermiaNumber of patients with postoperative temperature 36.0oCPatients undergoing surgery without CPB/planned hypothermiaPerioperative glycemic controlNumber of cardiac surgery patients with glucose control at 6AM pod 1 and 2Patients undergoing cardiac surgery

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ExecuteCultureDevelop a culture of intolerance for infectionStandardize/Reduce complexity of the processChecklists -Confirm abx administration during briefingUtilize a glycemic control protocolLocal antibiotic guidelines posted in ORsStandardize surgical skin prepRedundancyAdd best practices to briefing/debriefing checklistPost reminders in the OR (White board)Antibiotic timer program for redosingRegular team meetingsDevelop a project planIdentify barriers

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EvaluateTrack compliance with SCIP measuresPerformance measures already being tracked by hospitals as part of SCIP participation*Post performance on monthly basisPost in the OR, ICU and floorInvestigate non-compliant cases on a monthly basisUse Learning from Defect (LFD) toolPost SSI rates on a monthly/quarterly basisInvestigate each SSI with the CUSP team to identify areas for improvement using the LFD toolAudit performance with skin prep methodology (at a minimum) and goal is conversion to chlorhexidine

*Armstrong Institute for Patient Safety and Quality**based on data availability on Hospital compare

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Share Results*Armstrong Institute for Patient Safety and Quality*

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AcknowledgementsDeborah Hobson, BSNPamela Lipsett, MDSara Cosgrove, MDLisa Maragakis, MDTrish Perl, MDMatthew Huddle, BSNicole Errett, BSJustin Henneman, BSJoyce Wahr, MDThe Johns Hopkins SSI Prevention Collaborative teams

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QUESTIONS?Thank you!

Elizabeth Martinez, MD, MHSMassachusetts General Hospital, Harvard Medical Schoolmartinez.elizabeth@mgh.harvard.edu

Armstrong Institute for Patient Safety and Quality

*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.

*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

*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.

*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.

*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.

*Antibiotic levels of the individual agents must be higher than the MIC at the time of incisionIndividual agents must be consideredCefazolin has a Vd of 10-12 L can can be pushed within minutes of incisionAdditional 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 0-120 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.

*Observational studies have shown that repeated intraoperative dosing of an antibiotic with a short half-life is associated with a decreased risk of SSI.

*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.

*Portland Diabetic Project: MortalityAll patients with diabetes undergoing CABG (N = 3,554) were treated aggressively with either subcutaneous insulin (19871991) or continuous insulin infusion (19922001) 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;125:10071021.

Eliminating the diabetic disadvantage.

*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.

**