Adaptation and Implementation of Evidence-Based Clinical Practice Guidelines for Antibiotic Prophylaxis in Surgery in King Saud University Hospitals in Riyadh, Saudi Arabia

1. Antibiotic Prophylaxis in Surgery
An Adapted Clinical Practice Guideline
First Edition 2013
Presented By
Dr. Tarek Altokhais,
Consultant, Pedia Surgery & Head of Surgery CPG Subcommittee,
Surgery Department
Dr. Yasser Amer,
CPG General Coordinator, CPG Committee, QMD
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2. 09 JAN 2014
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4. Clinical
Care GAP
Best
Practice
Knowledge
Translation
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5. Clinical Practice Guidelines (CPGs) Program of King Saud
University Hospitals/ Medical City
KSUHs Taskforce Responsible Staff from:
Clinical Practice Guidelines Committee;
Quality Management Department;
Clinical Departments (CPGs subcommittees);
Shaikh Abdullah Bahamdan Research Chair
for Evidence-Based Health Care and
Knowledge Translation;
Top Management & Leadership of College of
Medicine and University Hospitals (Future KSU
Medical City)
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6. 18 CPGs Subcommittees - - ->> 21
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
Department of Pediatrics [12+1]
Department of Critical Care [2+1]
Department of Psychiatry [2]
Department of Community & Family Medicine (Family Medicine Unit)  FMC [1+6]
Department of Pharmacy [3+16]
New
Department of Emergency Medicine [+11]
1. Department of Occupational
Department of Medicine [8]
Health & Safety [2]
2. Department of Rehabilitation
Department of Orthopedic Surgery [1+1]
Medicine [+1]
Department of Otorhinolaryngology [1]
3. Health Education Center [+3]
Department of Ophthalmology [1]
Department of Cardiac Sciences (Cardiology – Cardiac Surgery)  KFCC [3]
Department of Surgery [2]
Department of Obstetrics & Gynecology [1+3]
Department of Dermatology [1]
Department of Anesthesiology [1]
Department of Laboratory Medicine & Pathology [+15]
Department of Radiology [+3]
Department of Nursing [1]
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7. Adapted from Source CPGs
CPG for Antimicrobial
Prophylaxis in Surgery
Developed by
American Society of Health System Pharmacists,
Infectious Diseases Society of America, Society
for Healthcare Epidemiology of America and
Surgical Infection Society. 1999 (updated 2013)
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9. Hospital-Wide Policy & Procedure for
Hospital CPGs Adaptation
SEPT 2013

10. CPG objective
To provide practitioners with a
standardized approach to the
rational, safe, and effective use of
antimicrobial agents for the prevention of
surgical-site infections (SSIs) based on
currently available clinical evidence and
emerging issues
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11. CPG Authorship group (CPG Champions)
Review group
Adaptation working group
1. Dr. Tariq Altokhais, Head
CPG Surg SubC, Consult.
Pedia Surg
2. Dr. Abdelmonim ElTarifi, Consult. Urology
3. Dr. Khalid Alawi, Consult.
Surg
4. Dr. Yasser Amer, CPGC,
QMD
Support group:
Dorothy Villena, CPGC
Sheila Rivera, CPGC
09 JAN 2014
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2.
3.
4.
5.
6.
7.
Antibiotic Prophylaxis in Surgery
Dr. Danny Rabah, Consultant
Urology
Dr. Badr Aljabri, Consultant
Vascular Surg
Dr. Wassim Hajar, Consultant
Thoracic Surg
Dr. Mohammad Qattan,
Consultant, Plastic Surg
Dr. Yaser Alfakey, Consultant
Ophthalmology
Dr. Khalid Alsaleh, Consultant
Orthopedic Surg/Spine, Head
Ortho CPG
Dr. Neama Meriki, Consultant
OBGYN, MFM, Head OBGYN CPG
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12. Search and Selection of source CPGs
•8 CPGs internet databases searched
•27 source CPGs retrieved
•25 CPGs excluded based on HQ and
selection criteria & 2 CPGs included for
further appraisal by AGREE II
Instrument.
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13. Health Questions (PIPOH)
P: Patient/target population:
Adult (age 19 years or older) and pediatric
(age 1–18 years) patients undergoing surgery.
Disease/Condition:
Postoperative infections (i.e., initial infection following
surgical procedures) without any other co-morbidities
Note: These CPGs do not specifically address newborn (premature and fullterm) infants.
While the CPGs do not address all concerns for patients with renal or hepatic
dysfunction, antimicrobial prophylaxis often does not need to be modified for
these patients when given as a single preoperative dose before surgical incision.
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14. PIPOH
I: Intervention and practices considered and
CPG Category:
Assessment of Therapeutic Effectiveness and
Prevention.
Primary
antimicrobial
prophylaxis
(i.e.,
prevention of an initial infection) for surgical
procedures, including antibiotic choice, dose,
and dosage regimen.
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15. PIPOH
P: Professionals and Intended Users (target
users/ stakeholders) and Clinical Specialty:
Physicians, Nurses, Allied Health Personnel and
Clinical Pharmacists in Departments of Surgery
and all Surgical subspecialties (Colon and Rectal
Surgery, Gastroenterology, Plastic Surgery,
Urology, Thoracic Surgery, Vascular Surgery and
Neurological Surgery), Obstetrics and Gynecology,
Orthopedic
Surgery,
Ophthalmology
and
Pharmacology.
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16. PIPOH
O: Major Outcomes Considered
1. Postoperative infection rates
2. Postoperative Morbidity and Mortality
rates
3. Duration and cost of health care
4. Adverse effects
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17. PIPOH
King Saud University Hospitals (KKUH/
KAUH) or KSU Medical City – Tertiary/
Governmental/ University Hospital –
Departments and clinics (mentioned in the
clinical specialty)
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18. Note: These CPGs reflect recommendations
for peri-operative antibiotic prophylaxis to
prevent SSI’s and do not apply for
prevention of opportunistic infections in
immunosuppressed transplantation patients
(e.g. for antifungal or antiviral medications).
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19. Inclusion / Exclusion source CPGs
Selection Criteria
1) Methods of Development; Evidence-Based CPGs: (Detailed
Methodology of Development Documented; link Recommendations
with Evidence; link to Systematic Reviews) rather than Consensusbased CPGs (Expert opinion)
2) Author(s) Organization (CPG development group) from CPGs
Database & Specialized Society (clinical specialty) NOT single
authors.
3) Country: international NOT national CPGs.
4) Date of Publication: range of year of publications: last 3 years
(2011 – 2013) NOT older.
5) Language: English CPGs only
6) Status: only Original source CPG (de novo developed) NOT
adapted CPGs
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20. AGREE II Domain Scores for the 2
source CPGs ASHP 2013 & ICSI 2012
AGREE II DOMAINS
ASHP 2013 CPG (%) ICSI 2012 CPG (%)
D1: Scope & Purpose
80
D2: Stakeholder
Involvement
D3: Rigour of Development
94
72
61
86
69
D4: Clarity & Presentation
94
42
83
Yes
69
D5: Applicability
D6: Editorial Independence
Overall Assessment
52
79
No
This table uses the AGREE II Domain Score Colour Coding proposed by Dr. Lubna Alansary
(< 40% red - > 41 – 70% yellow - > 71 % green)
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21. Evidence-Based
Recommendations
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22. Accreditation Canada International
Current ROP
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23. 2 Questions !!
When to START ?
When to STOP ?
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24. Preoperative-dose Timing
Optimal time for administration of pre-
operative antibiotics first dose is within 60
minutes before surgical incision (within
120 minutes for Vancomycin or
Fluoroquinolones due to prolonged
infusion times).
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25. Dosing & Re-dosing
Single dose prophylaxis is usually
sufficient, the duration of prophylaxis for most
procedures should be less than 24 hours.
The shortest effective duration of antimicrobial
administration for preventing SSI is unknown; however,
evidence is mounting that postoperative antimicrobial
administration is not necessary for most procedures.
Re-dosing may be required if surgery
duration is ≥ 2 half lives of chosen antimicrobial
or if blood loss is excessive.
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26. Dosing & Re-dosing (cont’d)
If an agent with a short half-life is used:(e.g. cefazolin, cefoxitin) it should be readministered if the procedure duration exceeds the
recommended redosing interval.
Re-administration:warranted If prolonged or excessive bleeding or if
other factors shorten the half-life of the prophylactic
agent (e.g. extensive burns).
Not be warranted for patients in whom the half-life
of the agent may be prolonged (e.g. renal insufficiency
or failure).
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27. Route of administration
IV route typically preferred due to
rapid, reliable, and predictable tissue
and serum concentrations
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28. Select Antimicrobial based on
1. Agent active against most common
pathogens for given procedure but
with as narrow spectrum as possible.
2. Safety profile of drug.
3. Patient allergies and co-morbidities.
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29. Rating Scheme for the Strength/ Levels of the Evidence
Level of Evidence
Type of Study
Level I
Evidence from large, well conducted, randomized, controlled clinical trials or a meta-analysis
Level II
Evidence from small, well conducted, randomized, controlled clinical trials
Level III
Evidence from well conducted cohort studies
Level IV
Evidence from well conducted case–control studies
Level V
Evidence from uncontrolled studies that were not well conducted
Level VI
Conflicting evidence that tends to favor the recommendation
Level VII
Expert opinion or data extrapolated from evidence for general principles and other procedures
Rating Scheme for the Strength/ Levels of Recommendations
Grade of R. (GoR)
Category A
Levels I-III
Category B
Levels IV-VI
Category C
09 JAN 2014
Level of E. (LoE)
Level VII
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30. EVIDENCE-BASED RECOMMENDATIONS
Thoracic Procedures
Recommended
Agents & Dosage
Cefazolin 2 g*
Ampicillin-sulbactam 3 g**
Alternative agents Clindamycin 900 mg
in Patients with B- Vancomycin 15 mg/kg
Lactam Allergy
Strength of
Evidence (accord. To
procedure)
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A, C
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31. Gatsrodudenal Procedures
Recommended
Cefazolin 2 g
Agents & Dosage
Alternative agents
Clindamycin 900 mg or
in Patients with BVancomycin 15 mg/kg +
Lactam Allergy
aminoglycoside or
Aztreonam 2 g or
Fluoroquinolone




Strength of Evidence
(accord. To procedure)
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A
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32. Biliary tract - Open Procedure
Recommended •Cefazolin 2 g*
Agents &
•Cefoxitin 2 g
Dosage
•Cefotetan 2 g
•Ceftriaxone 2 g
•Ampicillin-sulbactam 3 g**
Alternative
•Clindamycin 900 mg or
agents in
•Vancomycin 15 mg/kg + aminoglycoside***
Patients with
or
B-Lactam
•Aztreonam 2 g or fluoroquinolone****
Allergy
•Metronidazole 500 mg + aminoglycoside***
or fluoroquinolone****
Strength of
Evidence (accord.
To procedure)
09 JAN 2014
A
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33. Biliary tract - laparoscopic procedure
Recommended Elective, low-risk: none
Elective, high-risk:
Agents &
•Cefazolin 2 g*
Dosage
•Cefoxitin 2 g
•Cefotetan 2 g
•Ceftriaxone 2 g
•Ampicillin-sulbactam 3 g**
Alternative
agents in
Patients with
B-Lactam
Allergy
Elective, low-risk: none
Elective, high-risk:
•Clindamycin 900 mg or Vancomycin 15 mg/kg
+ aminoglycoside*** or
Aztreonam 2 g or fluoroquinolone****
•Metronidazole 500 mg + aminoglycoside***
or fluoroquinolone****
Strength of
Evidence (accord.
09 JAN 2014
To procedure)
A
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34. Appendectomy for uncomplicated appendicitis
Recommended •Cefoxitin 2 g
Agents &
•Cefotetan 2 g
Dosage
•Cefazolin 2 g* + metronidazole
Alternative
agents in
Patients with
B-Lactam
Allergy
Strength of
Evidence (accord.
To procedure)
09 JAN 2014
•Clindamycin 900 mg or vancomycin +
aminoglycoside*** or aztreonam 2 g or
fluoroquinolone****
•Metronidazole 500 mg +
aminoglycoside*** or
fluoroquinolone****
A
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35. Appendectomy for uncomplicated appendicitis
Recommended •Cefoxitin 2 g
Agents &
•Cefotetan 2 g
Dosage
•Cefazolin 2 g* + metronidazole
Alternative
agents in
Patients with
B-Lactam
Allergy
Strength of
Evidence (accord.
To procedure)
09 JAN 2014
•Clindamycin 900 mg or vancomycin
+ aminoglycoside*** or aztreonam 2 g
or fluoroquinolone****
•Metronidazole 500 mg +
aminoglycoside*** or
fluoroquinolone****
A
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36. Vascular Procedures
Recommended
Agents &
Dosage
Cefazolin 2 g*
Alternative
agents in
Patients with
B-Lactam
Allergy
Clindamycin 900 mg
Vancomycin 15 mg/kg
Strength of
Evidence (accord.
To procedure)
09 JAN 2014
A
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37. Recommended Agents & Dosage
Urologic procedure
Lower tract instrumentation with risk factors for infection:•Fluoroquinolone (e.g. ciprofloxacin 400mg)
•Trimethoprim-sulfamethoxazole
•Cefazolin 2 g*
Clean without entry into urinary tract:•Cefazolin 2 g*; addition of single dose of aminoglycoside
may be recommended for placement of prosthetic material
•If involving implanted prosthesis:
Cefazolin 2 g* with or without aminoglycoside
Cefazolin as dosed above with or without aztreonam 2g
Ampicillin-sulbactam 3 g**
Clean with entry into urinary tract:-Cefazolin 2 g*; addition of
single dose of aminoglycoside may be recommended for
placement of prosthetic material
Clean-contaminated:•Cefazolin 2 g*+ metronidazole 500 mg
•Cefoxitin 2 g
LoE
09 JAN 2014
A
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38. Alternative agents in Patients
with B-Lactam Allergy
Urologic procedures
Lower tract instrumentation with risk factors for
infection:
•Aminoglycoside*** with or without clindamycin 900 mg
Clean without entry into urinary tract:
•Clindamycin 900 mg
•Vancomycin 15 mg/kg
•If involving implanted prosthesis, consider adding
aminoglycoside*** or aztreonam 2 g to either regimen
Clean with entry into urinary tract:
•Fluoroquinolone****
•Aminoglycoside*** with or without clindamycin 900 mg
Clean-contaminated:
•Fluoroquinolone****
•Aminoglycoside*** + metronidazole 500 mg or
clindamycin 900 mg
LoE
09 JAN 2014
A
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39. Orthopedic procedures
Recommended Clean operations involving hand,
Agents &
knee, or foot and not involving
Dosage
implantation of foreign materials:-
None.
Spinal procedures with and
without instrumentation, hip
fracture repair, implantation of
internal fixation devices, total joint
replacement: Cefazolin 2 g*
LoE
09 JAN 2014
C, A
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40. Alternative agents in Patients
with B-Lactam Allergy
Orthopedic procedures
Clean operations involving hand, knee, or
foot and not involving implantation of
foreign materials:
•None
Spinal procedures with and without
instrumentation, hip fracture repair,
implantation of internal fixation devices,
total joint replacement:
•Clindamycin 900 mg
•Vancomycin 15 mg/kg
LoE
09 JAN 2014
A
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41. Plastic surgery -Clean with risk factors or cleancontaminated
Recommended
Agents & Dosage
•Cefazolin 2 g*
•Ampicillin-sulbactam 3 g**
Alternative agents
in Patients with BLactam Allergy
•Clindamycin 900 mg
•Vancomycin 15 mg/kg
Strength of Evidence
(accord. To procedure)
09 JAN 2014
Antibiotic Prophylaxis in Surgery
C
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42. Excluded recommendations
 The panel decided to exclude the
recommendations related to:1. Cardiac Surgery Procedures (Separate CPG)
2. Organ Transplantation Procedures (not
currently practiced in KSUMC)
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43. Implementation Strategies & Tools
TOOLS/ Resources:
 Quick Reference Guides
STRATEGIES
 Dissemination Process (print/
e-/website)
(Key Recommendations)
 Local Clinical Champions.
 Protocol
 Standing Orders: Paper  Awareness raising/ training
activities.
OR CPOE: Integration into
New HIS (e-SIHI) as CPOE (Power
Plans or Power Charts)
 Networking and linking with
existing projects.
 Patient Education Guide
 Patients as champions for
(in Ar/ Eng)
change.
 Clinical Audit tools/
Performance measures  Regular M & E.
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44. Thank YOU all for listening
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