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EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

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Page 1: EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

EMERGING EVIDENCE AROUND SURGICAL

PROPHYLAXIS:“the UPSIDES and the

DOWNSIDES”

Page 2: EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

Part 1: EXAMINING CAUSE AND EFFECT

Presented by Wendy Runge, RN, BScN, CIC

Infection Control Practitioner, Calgary AB

Page 3: EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

HEALTH CARE ASSOCIATED INFECTIONS (HCAI)

• THE BIG 3: SSI, CLI, VAP

• PREVENTION RESEARCH HAS IDENTIFIED EVIDENCE-BASED INTERVENTIONS(CLASS 1 EVIDENCE)

HOWEVER,

“NO GOOD DEED GOES UNPUNISHED”(Clare Boothe Luce)

Page 5: EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

SSI AND RISK

• RISK INCREASED BY:

– PATIENT FACTORS

– SURGICAL PROCEDURE

• RISK MAY BE DECREASED BY:

– COMPLIANCE WITH EVIDENCE-BASED PRACTICE

Page 6: EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

PROPHYLAXIS: the rationale

• SKIN CAN’T BESTERILISED

• SKIN FLORA WILL BETRACKED INTO DEEPERTISSUES

• PROVIDES SHORT-TERMSUPPORT FOR THE IMMUNE SYSTEM

Page 7: EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

ASSOCIATED RISKS

• INCREASED/IMPROPER USE OF ANTIBIOTICS HAS BEEN IMPLICATED IN: ANTIMICROBIAL RESISTANCE

– Clostridium difficile ASSOCIATED DIARRHEA (CDAD)

Page 8: EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

Staphylococcus aureus

• COMMON SKIN BACTERIUM

• PENICILLIN INTRODUCED1943; BY 1960, 80%RESISTANCE REPORTED

• 1ST CASE OF METHICILLIN- RESISTANCE WAS SEEN IN 1961 (MRSA)

• RELATIVELY SLOW EMERGENCE UNTIL 1990s

Page 9: EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

MRSA

• ADAPTS AND SHARES GENETIC INFORMATION

• ANTIMICROBIAL PRESSURE WILL SELECT FOR RESISTANT STRAINS

• RECENT EPIDEMIOLOGY:

– COMMUNITY ACQUISITION

– POOR ADHERANCE TO HAND HYGIENE IN HEALTH CARE

Page 10: EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

Emerging MRSA Epidemic Strains

0.0%

2.0%

4.0%

6.0%

8.0%

10.0%

12.0%

1995n=227

1996n=309

1997n=638

1998n=565

1999n=1083

2000n=773

2001n=1461

2002n=1365

2003n=1450

2004n=1658

2005n=1122

Year

Perc

ent M

RSA

Isol

ates CMRSA7

CMRSA8

CMRSA9

CMRSA10

Presented at the CNISP 2006 Annual Meeting

Page 11: EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

Clostridium difficile

• FOUND IN LOWER BOWEL, CAN BE PART OF RESIDENT FLORA

• SPORE-FORMER; SURVIVES FOR EXTENDED PERIODS IN THE ENVIRONMENT

• EXCRETES TOXINS WHICH CAN CAUSE TISSUE DAMAGE

Page 12: EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

C.difficile: Vegetative vs Spore

Vegetative form: metabolically active - Produces Toxin A & B (? Other)- Killed by some antibiotics only- Oxygen exposure kills

Spores: not metabolically active- No Toxin production, - Not affected by antibiotics- Oxygen exposure doesn’t kill

Dr. Michelle Alfa Ph.D, FCCMDiagnostic Services of ManitobaSt. Boniface General Hospital Site

Page 13: EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

CDAD (C. difficile associated diarrhea)

• ANTIMICROBIAL PRESSUREMAY ALLOW FOR OVERGROWTH

• RECOGNIZED AS PRIMARY CAUSE OF ANTIBIOTIC ASSOCIATED DIARRHEA IN 1978

• RECENT EMERGENCE OF NEW STRAINS CAUSING MORE SEVERE DISEASE

Page 14: EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

CDAD

• ANTIMICROBIALS MOST OFTEN IMPLICATED:

– CLINDAMYCIN

– 2ND AND 3RD GENERATION CEPHALOSPORINS

– FLUOROQUINOLONES

Page 15: EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

CDAD: MORE TO THE STORY?

• 2000 – 2001: LARGEST MULTICENTRE OUTBREAK TO DATE REPORTED IN CALGARY

• INVESTIGATIONAL FINDINGS:– FRAIL ELDERLY WITH MULTIPLE

COMORBIDITIES– ENVIRONMENTAL

CONTAMINATION– UNRESTRICTED USE OF

CLINDAMYCIN

Page 16: EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

CDAD PREVENTION

• ANTIMICROBIAL STEWARDSHIP

• ELIMINATING ENVIRONMENTAL RESERVOIRS

• CONTACT ISOLATION OF SUSPECT AND CONFIRMED CASES

Page 17: EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

PROPHYLAXIS DONE RIGHT!

• TARGETS THE ORGANISMS MOST LIKELY AT THE SURGICAL SITE

• DELIVERED AT THE OPTIMAL TIME

• PROPHYLAXIS VS TREATMENT

• “BUGS & DRUGS 2006 ANTIMICROBIAL REFERENCE BOOK”

Page 18: EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

Risk Evaluation of Risk Evaluation of Clostridium difficileClostridium difficile-Associated Diarrhea -Associated Diarrhea

Following Antimicrobial Prophylaxis Following Antimicrobial Prophylaxis in Patients Undergoing in Patients Undergoing

Cardiac, Vascular or Thoracic Surgery in a Cardiac, Vascular or Thoracic Surgery in a Tertiary Care Trauma CenterTertiary Care Trauma Center

D.J.G. Thirion, M.Sc., Pharm.D., BCPSD.J.G. Thirion, M.Sc., Pharm.D., BCPS

Clinical Assistant Professor, PharmacistClinical Assistant Professor, Pharmacist

Hôpital du Sacré-Cœur de MontréalHôpital du Sacré-Cœur de Montréal

Faculty of Pharmacy, Université de MontréalFaculty of Pharmacy, Université de Montréal

Paper K-351Paper K-351

ICAAC 2006ICAAC 2006

Page 19: EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

BackgroundBackground

Antimicrobial prophylaxis (AP) is Antimicrobial prophylaxis (AP) is standard of practice forstandard of practice for– Cardiac, thoracic, vascular surgery Cardiac, thoracic, vascular surgery

AP decreases surgical site infections AP decreases surgical site infections (SSIs)(SSIs)

Risk of Risk of C. difficileC. difficile associated associated diarrhea (CDAD) has been low diarrhea (CDAD) has been low historically (1.2%)historically (1.2%) Harbarth Harbarth et al.et al. J Hosp Inf 2001;48:93-97 J Hosp Inf 2001;48:93-97

Page 20: EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

Antibiotic prophylaxis protocolAntibiotic prophylaxis protocol

Promoting rational use of antibiotic Promoting rational use of antibiotic prophylaxis in surgery canprophylaxis in surgery can Surgical Site Infections Surgical Site Infections length of staylength of stay therapeutic use of antimicrobialstherapeutic use of antimicrobials

Improve costsImprove costs

Thirion DJG et al. Thirion DJG et al. Applied Therapeutics. 2004Applied Therapeutics. 2004

Page 21: EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

Appropriate use to decrease risks Appropriate use to decrease risks (pitfalls!)(pitfalls!)

Adverse reactionsAdverse reactions– Allergic or toxic reactionsAllergic or toxic reactions– Clostridium difficileClostridium difficile (superinfection) (superinfection) (Spencer RC. AAC 1998)(Spencer RC. AAC 1998)

Development of resistanceDevelopment of resistance– Vancomycin resistant enterococci (VRE)Vancomycin resistant enterococci (VRE)

Page 22: EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

CDADCDAD

Outbreak in Quebec, Canada associated Outbreak in Quebec, Canada associated with new strain (BI/NAP1 toxinotype III)with new strain (BI/NAP1 toxinotype III)– Average rate of up to 20 cases/1000 Average rate of up to 20 cases/1000

admissionsadmissions– Increased mortality, morbidityIncreased mortality, morbidity– Increased severity of diseaseIncreased severity of disease

Onset of disease closely related to Onset of disease closely related to antimicrobial exposureantimicrobial exposure

Outbreak of CDAD may expose pts to Outbreak of CDAD may expose pts to higher adverse risk with APhigher adverse risk with AP

Loo V, Loo V, et al.et al. N Engl J Med 2005;353:2442-9. N Engl J Med 2005;353:2442-9.McDonald LC, McDonald LC, et al.et al. N Engl J Med 2005;353:2433-41. N Engl J Med 2005;353:2433-41.

Page 23: EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

AssessmentAssessment

Adverse outcomes with CDAD may Adverse outcomes with CDAD may surpass benefits of APsurpass benefits of AP

Purpose:Purpose:– To evaluated the risk of CDAD and its To evaluated the risk of CDAD and its

complicationscomplications– Following APFollowing AP– In cardiac, thoracic, and vascular In cardiac, thoracic, and vascular

surgerysurgery

Page 24: EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

MethodologyMethodology

Retrospective cohort studyRetrospective cohort study University affiliated tertiary trauma centerUniversity affiliated tertiary trauma center Pts who underwentPts who underwent

– Cardiac surgeryCardiac surgery– Thoracic surgeryThoracic surgery– Vascular surgeryVascular surgery

January 1January 1stst 2002 to December 31 2002 to December 31stst 2004 2004 AP 4 hours prior to and up to 2 hours AP 4 hours prior to and up to 2 hours

after beginning of surgeryafter beginning of surgery 2 surgeries in the same patient were 2 surgeries in the same patient were

considered as separate eventsconsidered as separate events Pts who did not receive AP were excludedPts who did not receive AP were excluded

Page 25: EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

OutcomesOutcomes

PRIMARY OUTCOMEPRIMARY OUTCOME– Occurrence of CDADOccurrence of CDAD (post-op. up to 1 mo. post-op.)(post-op. up to 1 mo. post-op.)

• Positive Positive C. difficileC. difficile toxin A and/or B assay and 3 or more toxin A and/or B assay and 3 or more episodes of diarrhea/dayepisodes of diarrhea/day

• Endoscopic evidence of pseudomembranous colitisEndoscopic evidence of pseudomembranous colitis• Histopathological evidence of Histopathological evidence of C. difficileC. difficile colitis colitis

– Complications of CDADComplications of CDAD(from hospitalisation and up to 3 months post CDAD)(from hospitalisation and up to 3 months post CDAD)

• Pseudomembranous colitisPseudomembranous colitis• Toxic megacolonToxic megacolon• PerforationPerforation• Surgery or colectomySurgery or colectomy• RelapseRelapse• DeathDeath

•Septic choc Septic choc •ICU admission forICU admission for

Dehydration Dehydration Electrolyte Electrolyte

disordersdisordersHypovolemia Hypovolemia Septic shockSeptic shock

1 of 31 of 3

Page 26: EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

OutcomesOutcomes

SECONDARY OUTCOMESECONDARY OUTCOME Risk factors for CDADRisk factors for CDAD Surgical site infectionsSurgical site infections

– SuperficialSuperficial< 30 days post-op< 30 days post-op

– DeepDeep< 30 days post-op < 30 days post-op

< 1 year post-op if material implant< 1 year post-op if material implant

Page 27: EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

Statistical analysisStatistical analysis

Rates of CDAD (95% CI)Rates of CDAD (95% CI) Risk of complications with CDADRisk of complications with CDAD Rates of SSIs (95% CI)Rates of SSIs (95% CI) Logistic regression for influence of Logistic regression for influence of

different risk factors on the incidence different risk factors on the incidence of CDAD (OR, 95% CI)of CDAD (OR, 95% CI)

Page 28: EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

Baseline characteristics of patients undergoing Baseline characteristics of patients undergoing cardiac, thoracic or vascular surgerycardiac, thoracic or vascular surgery

Baseline characteristicsBaseline characteristics GlobalGlobaln = 1688n = 1688

CardiacCardiacn = 832n = 832

ThoracicThoracicn = 350n = 350

VascularVascularn = 506n = 506

Mean age Mean age (years) 64.164.1 63.663.6 60.960.9 67.067.0

Percentage of women Percentage of women 31.031.0 27.227.2 39.139.1 31.831.8

Hospital stayHospital stay Mean duration Mean duration (days SD)

15.9 15.9 19.3 19.3 15.1 15.1 11.5 11.5 19.6 19.6 22.3 22.3 14.7 14.7 25.9 25.9

Median days Median days (range) 11 (1-187)11 (1-187) 12 (1-144)12 (1-144) 13 (2-236)13 (2-236) 8 (1-387)8 (1-387)

Co-morbiditiesCo-morbidities

Mean number of co-morbiditiesMean number of co-morbidities 3.33.3 3.83.8 3.33.3 2.52.5

Diabetes (%)Diabetes (%) 22.322.3 26.926.9 13.413.4 20.920.9

COPD (%)COPD (%) 19.819.8 9.09.0 49.749.7 16.816.8

Active malignancy (%)Active malignancy (%) 17.117.1 1.41.4 76.976.9 1.61.6

Anemia (%)Anemia (%) 7.07.0 6.66.6 8.68.6 6.76.7

Renal insufficiency (CrCl Renal insufficiency (CrCl 30 mL/min) 30 mL/min) (%)(%)

3.63.6 3.43.4 1.11.1 5.75.7

Heart failure (%)Heart failure (%) 2.42.4 3.73.7 0.90.9 1.41.4

Rhumatoid Arthritis (%)Rhumatoid Arthritis (%) 0.90.9 0.80.8 0.90.9 1.21.2

Gastro-intestinal disease (CD, UC) (%)Gastro-intestinal disease (CD, UC) (%) 0.50.5 0.60.6 00 0.60.6

SD, standard deviation; COPD, chronic obstructive pulmonary disease; CrCl, creatinine clearance; UC, SD, standard deviation; COPD, chronic obstructive pulmonary disease; CrCl, creatinine clearance; UC, ulcerative colitis; CD, crohn’s disease.ulcerative colitis; CD, crohn’s disease.

Page 29: EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

Rate of CDAD, complications of CDAD, Rate of CDAD, complications of CDAD, and SSIs in cardiac, thoracic and and SSIs in cardiac, thoracic and

vascular surgery patientsvascular surgery patients

GlobalGlobal CardiacCardiac ThoracicThoracic VascularVascular

Number of patientsNumber of patients 16881688 832832 350350 506506

Number of CDADsNumber of CDADsaa 8282 3535 2424 2323

Number of Number of complicationscomplicationsbb 2121 99 88 44

Number of superficial Number of superficial SSIsSSIs 4747 2525 33 1919

Number of deep SSIsNumber of deep SSIscc 1212 88 00 44

a: CDAD was evaluated up to 30 days after surgerya: CDAD was evaluated up to 30 days after surgeryb: Complications were evaluated up to 3 months post-CDADb: Complications were evaluated up to 3 months post-CDADc: SSIs were evaluated up to 1 year post surgeryc: SSIs were evaluated up to 1 year post surgery

Page 30: EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

Rates of CDAD, complications of CDAD, Rates of CDAD, complications of CDAD, superficial SSIs and deep SSIs in superficial SSIs and deep SSIs in

cardiac, thoracic and vascular surgerycardiac, thoracic and vascular surgery

0

1

2

3

4

5

6

7

8

Cardiac (n=832) Thoracic (n=350) Vascular (n=506)

Type of surgery

CDAD

CDAD complications

Superficial SSI

Deep SSI

Over a 3 year period (2002-2004)Over a 3 year period (2002-2004)

Rat

e (%

)R

ate

(%)

Page 31: EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

ObservationsObservations

Pts developed CDAD on average 9 d Pts developed CDAD on average 9 d (range 2-30 d) post-surgery (range 2-30 d) post-surgery

CDAD pts had longer hospital stay CDAD pts had longer hospital stay (32.1 d vs 15.1 d) than non-CDAD pts(32.1 d vs 15.1 d) than non-CDAD pts

AP was the only antibiotic received AP was the only antibiotic received in perioperative care in perioperative care – 45.1% of patients with CDAD45.1% of patients with CDAD– from 3 months before surgery until from 3 months before surgery until

diagnosis of CDADdiagnosis of CDAD No CDAD related deaths reportedNo CDAD related deaths reported

Page 32: EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

Rate of CDAD per year in cardiac, Rate of CDAD per year in cardiac, thoracic and vascular surgerythoracic and vascular surgery

2,3

4,63,9

10,6

0,5

7,7

6,15,5 5,6

0

2

4

6

8

10

12

2002 2003 2004

Year of surgery

Cardiac

Thoracic

Vascular

Rat

e (%

)R

ate

(%)

n = 1688n = 1688

Page 33: EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

Logistic regression of potential risk Logistic regression of potential risk factors for CDAD among surgical ptsfactors for CDAD among surgical pts

Potential risk factorsPotential risk factors Odd ratioOdd ratio 95% C.I.95% C.I. P-valueP-value

LowerLower UpperUpper

Parenteral nutritionParenteral nutrition 6.46.4 2.72.7 15.015.0 <0.001<0.001

Enteral nutritionEnteral nutrition 4.34.3 2.32.3 8.28.2 <0.001<0.001

Diabetes Diabetes 0.90.9 0.50.5 1.51.5 0.60.6

COPDCOPD 2.02.0 1.21.2 3.43.4 0.010.01

UC/CDUC/CD 3.73.7 0.40.4 31.431.4 0.20.2

Renal insufficiencyRenal insufficiencyaa 1.61.6 0.60.6 4.34.3 0.30.3

Heart failureHeart failure 1.81.8 0.60.6 5.75.7 0.30.3

AnemiaAnemia 1.41.4 0.60.6 2.92.9 0.40.4

MalignancyMalignancy 1.31.3 0.70.7 2.42.4 0.40.4

ImmunosupressionImmunosupression 00 00 -- 1.01.0

H2 antagonistsH2 antagonists 2.52.5 0.80.8 7.47.4 0.10.1

PPIPPI 1.01.0 0.60.6 1.71.7 1.01.0

RARA 00 00 -- 1.01.0

a: Renal insufficiency defined as a creatinine clearance less than 30mL/mina: Renal insufficiency defined as a creatinine clearance less than 30mL/min

Page 34: EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

Antimicrobial agents used, moment of Antimicrobial agents used, moment of administration, and duration of administration, and duration of

antimicrobial prophylaxisantimicrobial prophylaxisCardiac (%) Cardiac (%)

(n = 832)(n = 832)Thoracic (%) Thoracic (%)

(n = 350)(n = 350)Vascular (%)Vascular (%)

(n = 506)(n = 506)

CefazolinCefazolin 43.943.9 74.974.9 91.191.1

Cloxacillin + Cloxacillin + AmpicillinAmpicillin

52.552.5 2.42.4 4.24.2

VancomycineVancomycine 3.43.4 3.53.5 3.23.2

OtherOther 0.20.2 19.219.2 1.51.5

Moment of Moment of administrationadministration a, b a, b

34.134.1 12.312.3 16.316.3

Duration of AP Duration of AP 24 24 hourshours

45.345.3 78.178.1 83.183.1

Duration of AP > 24 Duration of AP > 24 hourshours

54.754.7 21.921.9 16.916.9

a: Administration of antimicrobial prophylaxis between 30 minutes to 1 hour before the surgical incision. a: Administration of antimicrobial prophylaxis between 30 minutes to 1 hour before the surgical incision. b: Documentation of the moment of administration was absent from charts in 25.7% of charts overall. b: Documentation of the moment of administration was absent from charts in 25.7% of charts overall.

Page 35: EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

DiscussionDiscussion

AP is not without risk, especially in epidemic AP is not without risk, especially in epidemic areas of CDADareas of CDAD – AP exposes patients to a AP exposes patients to a highhigh risk of CDAD, which can risk of CDAD, which can

lead to additional morbidity, length of stay, and hospital lead to additional morbidity, length of stay, and hospital costs. costs.

– The risk of CDAD with AP use outweighs the benefits in The risk of CDAD with AP use outweighs the benefits in thoracic surgery. thoracic surgery.

AP in surgeries at low risk of SSIs needs to be re-AP in surgeries at low risk of SSIs needs to be re-evaluated in the context of CDAD outbreaks.evaluated in the context of CDAD outbreaks.

Confirms other reports that enteral and parenteral Confirms other reports that enteral and parenteral nutrition, and COPD are risks for development of nutrition, and COPD are risks for development of CDADCDAD

Page 36: EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

AcknowledgementsAcknowledgements

David Banon, B. Pharm.David Banon, B. Pharm.1, 21, 2

Catherine Ferland, B. Pharm. Catherine Ferland, B. Pharm. 1, 21, 2

Anik Thibodeau, B. Pharm. Anik Thibodeau, B. Pharm. 1, 21, 2

Karine Wilhelmy , B. Pharm. Karine Wilhelmy , B. Pharm. 1, 21, 2

Pierre J. Laflamme, MDPierre J. Laflamme, MD11

Gilbert Pichette, MDGilbert Pichette, MD11

Thérèse Bigras, M.Sc.Inf., MBAThérèse Bigras, M.Sc.Inf., MBA11

Anne Filion, B.Pharm., M.Sc. Anne Filion, B.Pharm., M.Sc. 11

Lucie Blais, Ph.D. Lucie Blais, Ph.D. 1, 21, 2

1.1.

2.2.

Page 37: EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

Definitions of SSIsDefinitions of SSIs

SuperficialSuperficial– < 30 days post-op< 30 days post-op

++– Skin or soft tissue involvment onlySkin or soft tissue involvment only

++– One of the followingOne of the following

» Purulent drainagePurulent drainage» S/sx of infection and opening of the wound by the S/sx of infection and opening of the wound by the

surgeonsurgeon» Diagnosis of superficial surgical site infectionDiagnosis of superficial surgical site infection» Positive culture from site using aseptic techniquePositive culture from site using aseptic technique

Page 38: EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

Definitions of SSIsDefinitions of SSIs

DeepDeep– < 30 days post-op or< 30 days post-op or– < 1 year post-op if material implants< 1 year post-op if material implants ++– Infection seems related to surgeryInfection seems related to surgery ++– Affects deep tissue including fascia and muscleAffects deep tissue including fascia and muscle ++– One of the followingOne of the following

» Purulent drainage from deep wound ( but not cavity or Purulent drainage from deep wound ( but not cavity or organ)organ)

» Spontaneous dehiscance opening of the deep wound by Spontaneous dehiscance opening of the deep wound by the surgeon when T>38°C or localized painthe surgeon when T>38°C or localized pain

» Abcess or evidence of infection by direct or radiological Abcess or evidence of infection by direct or radiological exam, subsequent surgery, or histopathologyexam, subsequent surgery, or histopathology

» Diagnosis of deep SSIDiagnosis of deep SSI

Page 39: EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

Definition of CDAD complicationsDefinition of CDAD complications

ICU admissionICU admission– Dehydration, electrolyte disorders, hypovolemia, septic shockDehydration, electrolyte disorders, hypovolemia, septic shock

Septic shockSeptic shock– Hypotension SBP < 90 mmHg, decrease > 40 mmHg, in the Hypotension SBP < 90 mmHg, decrease > 40 mmHg, in the

absence of other causes absence of other causes + 2 of the following:+ 2 of the following:– temp > 38°C or < 36°C, HR > 90 bpm, RR > 20/min, pCO2 < 32 temp > 38°C or < 36°C, HR > 90 bpm, RR > 20/min, pCO2 < 32

mmHg, WBC > 12 000 or < 4000, or > 10% bandsmmHg, WBC > 12 000 or < 4000, or > 10% bands Pseudomembranous colitis: confirmed by endoscopyPseudomembranous colitis: confirmed by endoscopy Toxic megacolon: > 6 cm dilation, confirmed by X-ray, Toxic megacolon: > 6 cm dilation, confirmed by X-ray,

+ 3 of the following:+ 3 of the following:fever > 38.5°C, tachycardia HR>120 bpm, WBC > 10 500, anemia, fever > 38.5°C, tachycardia HR>120 bpm, WBC > 10 500, anemia,

dehydration, confusion, electrolyte disorders, hypotensiondehydration, confusion, electrolyte disorders, hypotension Colon perforation: confirmed by radiographyColon perforation: confirmed by radiography Relapse: readmissioin to the hospital for CDAD following Relapse: readmissioin to the hospital for CDAD following

initial remissioninitial remission Death as confirmed on death certificateDeath as confirmed on death certificate

Page 40: EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

Rates of CDAD, complications of CDAD, Rates of CDAD, complications of CDAD, overall SSIs in cardiac, thoracic and overall SSIs in cardiac, thoracic and

vascular surgeryvascular surgery

0

1

2

3

4

5

6

7

8

9

10

Cardiac (n=832) Thoracic (n=350) Vascular (n=506)

Type of surgery

CDAD

CDAD complications

Overall SSI

Over a 3 year period (2002-2004)Over a 3 year period (2002-2004)

Rat

e (%

)R

ate

(%)

95% CI95% CI

Page 41: EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

Prevention and ChangePrevention and Change

Page 42: EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

Questions to consider in Prevention

Questions to consider in Prevention

What is the burden of diseaseIs there any proven benefit from the intervention?If there is, how great is it ?Are there any adverse effects of the intervention?If there are, what are they, how serious are they, and how frequently do they occur?Informed consent.

What is the burden of diseaseIs there any proven benefit from the intervention?If there is, how great is it ?Are there any adverse effects of the intervention?If there are, what are they, how serious are they, and how frequently do they occur?Informed consent.

Page 43: EMERGING EVIDENCE AROUND SURGICAL PROPHYLAXIS: “the UPSIDES and the DOWNSIDES”

Size of benefitSize of benefit

Multiple studies actual results varied however OR in ranges of 0.30 to 0.5 in antibiotic vs placebo trials

Number needed to treat (NNT) approximately 6

Multiple studies actual results varied however OR in ranges of 0.30 to 0.5 in antibiotic vs placebo trials

Number needed to treat (NNT) approximately 6

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Adverse events - frequencyAdverse events - frequency

Gillespie 2000 - Cochrane collaboration

RR 1.83 (0.96 -3.5)Crabtree TD, et al. Am Surg. 1999. 65:507-511. In16% of post surgical patients with C. difficile colitis the antibiotics were prophylactic.Antibiotic resistance - associated with antibiotic use - ? relevance to a single dose regimen

Gillespie 2000 - Cochrane collaboration

RR 1.83 (0.96 -3.5)Crabtree TD, et al. Am Surg. 1999. 65:507-511. In16% of post surgical patients with C. difficile colitis the antibiotics were prophylactic.Antibiotic resistance - associated with antibiotic use - ? relevance to a single dose regimen

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Evidence supports the use of prophylactic antibiotics.

the current benefit : harm ratio is favorable

However:

Evidence supports the use of prophylactic antibiotics.

the current benefit : harm ratio is favorable

However:

SummarySummary

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Microorganisms are not boring-change is constant

The healthcare system should not be boring - change needs to be constant.

Microorganisms are not boring-change is constant

The healthcare system should not be boring - change needs to be constant.

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MRSAMRSAAn abridged and selected

HistoryAn abridged and selected

History

Pre Penicillin 1942Mortality sepsis secondary pneumonia, osteomyelitis, cellulitis > 80%

Pre Penicillin 1942Mortality sepsis secondary pneumonia, osteomyelitis, cellulitis > 80%

Penicillin 1942Mortality sepsis secondary pneumonia, osteomyelitis, cellulitis 35%

Penicillin 1942Mortality sepsis secondary pneumonia, osteomyelitis, cellulitis 35%

1945 Penicillinase lactamase

1945 Penicillinase lactamase

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Mid 1940s Penicillin resistance. Mortality rates increase to pre penicillin era

Mid 1940s Penicillin resistance. Mortality rates increase to pre penicillin era

late 1940s - 1950s Staphylococcal epidemics (Golden Staph)- Birth of Hospital Infection Control

late 1940s - 1950s Staphylococcal epidemics (Golden Staph)- Birth of Hospital Infection Control

1959 semi synthetic penicillins-methicillin1959 semi synthetic penicillins-methicillin

1961 MRSA England1961 MRSA England

1963 MRSA outbreaks Europe1963 MRSA outbreaks Europe

1967 MRSA in US1967 MRSA in US

1968 first hospital MRSA outbreak in US1968 first hospital MRSA outbreak in US

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1980 first reports from LTCF1980 first reports from LTCF

1992 aboriginal children western Australia CA MRSA

1992 aboriginal children western Australia CA MRSA

2000 multiple outbreaks, prisons, schools, schools, athletic teams, Military, increasing prevalence children. (CA MRSA)

2000 multiple outbreaks, prisons, schools, schools, athletic teams, Military, increasing prevalence children. (CA MRSA)

1995 -change in sensitivity profiles - Europe

1995 -change in sensitivity profiles - Europe

1999 17% Nosocomial MRSA - Harbor UCLA SCC mec IV (CA MRSA)

1999 17% Nosocomial MRSA - Harbor UCLA SCC mec IV (CA MRSA)

55.3 % ICU isolates HA MRSA55.3 % ICU isolates HA MRSA

∂∂

1975 2.1% ICU S. aureus are MRSA in the US

1975 2.1% ICU S. aureus are MRSA in the US

∂∂

1986 Cluster of MRSA in Aboriginal community Canada

1986 Cluster of MRSA in Aboriginal community Canada

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Interesting times ahead

Interesting times ahead

Change is constantSurveillance is mandatory

Change is constantSurveillance is mandatory

2003 Harbor UCLA 53% Nosocomial MRSA - is CA phenotype SCC mec type IV

2003 Harbor UCLA 53% Nosocomial MRSA - is CA phenotype SCC mec type IV

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Evolution in Health Care Systems

Evolution in Health Care Systems

Surgical Infection Prevention(SIP) project.Antibiotic selection suspended as a publically reported measure of hospital quality.Reasons:

MRSA - guidelines not in agreement on when Vancomycin should be used as prophylaxis-what is a high prevalence of MRSA?Antibiotic shortages.Conflicting guidelines regarding preventing SSI and endocarditis in surgical patients.

Surgical Infection Prevention(SIP) project.Antibiotic selection suspended as a publically reported measure of hospital quality.Reasons:

MRSA - guidelines not in agreement on when Vancomycin should be used as prophylaxis-what is a high prevalence of MRSA?Antibiotic shortages.Conflicting guidelines regarding preventing SSI and endocarditis in surgical patients.

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RememberRemember

Organisms change.

New knowledge is accumulating.

There is an absolute need to monitor what is happening in your institution.

There is a need for organizations such as Safer Healthcare Now to regularly review the recommendations in their guidelines.

Organisms change.

New knowledge is accumulating.

There is an absolute need to monitor what is happening in your institution.

There is a need for organizations such as Safer Healthcare Now to regularly review the recommendations in their guidelines.

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Thank you and have a good dayThank you and have a good day