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1 Clinical Guideline Surgical Antibiotic Prophylaxis Sites where Clinical Guideline applies All facilities where surgery is carried out This Clinical Guideline applies to: 1. Adults Yes 2. Children up to 16 years Yes 3. Neonates less than 29 days No Approval gained from the Children Young People and Families Network on 6 May 2014 Target audience Description Surgeons, anaesthetists, intensivists and pharmacists This document consists of expert recommendations for surgical antibiotic prophylaxis in facilities managed by Hunter New England Local Health District (HNELHD). Hyperlink to Guideline Keywords Antibiotic, surgical, orthopaedic, prophylaxis, wound, infection, stewardship, patient safety. Document Registration Number HNELHD CG 14_35 Replaces Existing Guideline? Registration Numbers of Superseded Documents Yes HNEH CPG 09_17 from December 2010; HNEH CPG 08_06 Related Legislation, Australian Standard, NSW Ministry of Health Policy Directive or Guideline, National Safety and Quality Health Service Standard (NSQHSS) and/or other, HNE Health Document, Professional Guideline, Code of Practice or Ethics: National Safety & Quality Health Standard 3.14 Therapeutic Guidelines: Antibiotic, Therapeutic Guidelines, Melbourne, Victoria 2010 Position responsible for Clinical Guideline Governance Clinical Guideline Contact Officer Contact Details Infection Prevention and Control Committee Dr Rod Givney rodney.givney@hnehealth.nsw.gov.au Date authorised 15 December 2014 This Clinical Guideline contains advice on therapeutics Yes Approval gained from HNE Quality Use of Medicines Committee on 4 November 2014 Issue date 17 December 2014 Review date 17 December 2017 TRIM number 14/ Version One December 2014

2 TABLE OF CONTENTS Surgical Antibiotic Prophylaxis HNELHD CG 14_35 Risk Statement Page 2 Guideline Summary Page 2 Glossary Page 3 ANTIBIOTIC PROPHYLAXIS FOR PROCEDURES OTHER THAN ORTHOPAEDIC PROCEDURES Page 4 ANTIBIOTIC PROPHYLAXIS FOR ORTHOPAEDIC PROCEDURES Page 5 ANTIBIOTIC RECOMMENDATIONS BY ANTIBIOTIC TYPE Page 6 Implementation Plan Page 7 Monitoring and auditing plan, Consultation with key stakeholders, Feedback Page 7 Note: Over time links in this document may cease working. Where this occurs please source the document in the PPG Directory at: RISK STATEMENT: The risk of post-surgical infection is significantly decreased by the use of correct choice, dose & duration of antibiotic prophylaxis, and by the pre-emptive treatment of established but not yet overt infection, notably in trauma patients. The risk of avoidable antimicrobial resistance is decreased by correct choice, dose & duration of antibiotics. RISK CATEGORY: Clinical Care & Patient Safety SUMMARY The optimal time for administration of preoperative intravenous antibiotics is within 60 minutes before surgical incision; data suggests administration between 15 to 30 minutes before surgical incision may be best. Except where explicitly stated, only a single preoperative dose is indicated. Cephazolin dose for all adult patients is 2 grams IV, regardless of weight. Repeat the cephazolin dose intraoperatively if the procedure lasts more than 3 hours. Check if preoperative Staphylococus aureus (including MRSA) screening was performed to determine if a patient requires a glycopeptide (teicoplanin) for MRSA carriage. Teicoplanin is now the glycopeptide of choice because of its simple dosing regimen (once only over 5 minutes) compared with vancomycin s (see Table 3, page 6). This should facilitate effective prophylaxis. However, teicoplanin costs $36 for a 400mg ampoule while vancomycin costs only $2.06 for a 500mg ampoule, so vancomycin remains in this guideline as an alternative. For patients already receiving regular doses of β-lactam antibiotics with activity against likely intraoperative pathogens, recommended prophylaxis may be omitted if it is likely that a steady state concentration above the relevant minimal inhibitory concentration has been reached. Version One December 2014 Page 2

3 GLOSSARY Surgical Antibiotic Prophylaxis HNELHD CG 14_35 Acronym or Term BV DTC GIT HNE LHD HNE LHD AWP HSM IV JMO LSCS MRSA QUMC SSI VMO Definition Bacterial vaginosis Drugs & Therapeutics Committee Gastrointestinal Hunter New England Local Health District Hunter New England Local Health District Antimicrobial Working Party Health Service Manager Intravenous Junior Medical Officer Lower section caesarean section Methicillin-resistant Staphylococcus aureus Quality Use of Medicines Committee Surgical site infection Visiting Medical Officer Version One December 2014 Page 3

4 TABLE 1 ANTIBIOTIC PROPHYLAXIS FOR PROCEDURES OTHER THAN ORTHOPAEDIC PROCEDURES Procedure First Line Second Line (Major beta lactam allergy / MRSA) Abdominal surgery (colorectal, upper GIT/ biliary, including laparoscopic surgery, but not pyloromyotomy). Amputation of ischaemic lower limb. 4 Caesarean section (LSCS). Cephazolin 2g IV (Child 25mg/kg up to 2g). 1 Lincomycin or clindamycin 600mg IV 2,3 AND gentamicin 2mg/kg IV. Benzylpenicillin 1.2g IV at Metronidazole 500mg IV. Repeat dose at induction & 6 hourly for 24 hours. 12 hours. Cephazolin 2g IV. Lincomycin or clindamycin 600mg IV. 3 Cardiac Catheter Laboratory (Defibrillator device /permanent pacemaker insertion). Cardiac (thoracic) surgery 2. Head and neck & ear/nose/throat (ENT) surgery. 5 Hysterectomy 7 (abdominal or vaginal hysterectomy) or termination of pregnancy. Neurosurgery (prolonged procedure anticipated, re-explorations, microsurgery or insertion of prosthetic materials except 8 as listed). Vascular (1): Angiography Vascular (2): Aortic & all other with procedures involving prosthetic material. Vascular (3): Fistula formation with prosthetic graft. Vascular surgery (4) 2 : All infrarenal procedures Cephazolin 2g IV AND (if re-do) teicoplanin 800mg. Cephazolin 2g IV THENCE 8 hourly for 2 further doses AND (if MRSA carriage or valve redo) ADD teicoplanin 800mg IV single. Cephazolin 2 g IV AND in some circumstances 6 ADD metronidazole 500 mg IV. Cephazolin 2 g IV AND metronidazole 500mg IV. Cephazolin 2 g IV (child: 25 mg/kg up to 2g). Cephazolin 2g IV (child: 25 mg/kg up to 2 g). Cephazolin 2g IV (child: 25 mg/kg up to 2 g) AND (if pre-existing open wound) teicoplanin 800mg (child 20mg/kg up to 800mg) IV prior Cephazolin 2g IV (child: 25mg/kg up to 2g) AND teicoplanin 800mg (child 20mg/kg up to 800mg) IV prior Cephazolin 2g IV THENCE 8- hourly for 24 hours AND (if inguinal or more distal incision with insertion of graft) ADD Teicoplanin 800mg IV prior Teicoplanin 800mg IV. Teicoplanin 800mg IV AND ciprofloxacin 400mg IV single dose. Lincomycin or clindamycin 600mg IV. 3 Metronidazole 500mg IV AND gentamicin 2mg/kg IV. 800mg) IV prior 800mg) IV prior 800mg) IV prior 800mg) IV prior Teicoplanin 800mg IV single dose prior to induction AND gentamicin 5mg/kg single dose IV. 1. Add metronidazole 500 mg (child: 12.5 mg/kg up to 500 mg) only in small intestine surgery with obstruction and colorectal surgery. 2.Preoperative Staphylococus aureus (MRSA) nasal screening & decolonisation (load reduction) is indicated for: (1) oesophagectomy & partial hepatectomy (2) All cardiac (thoracic) surgery (3) All infrarenal vascular procedures. See Management of Multi-resistant Organisms and Clostridium difficile PD2007_084:PCP 1 data/assets/pdf_file/0012/120153/pd2007_084_pcp_1_multi- Resistant_Organisms_and_Clostridium_Difficile.pdf pages Section E Check the MRSA is susceptible to clindamycin. If not, add teicoplanin. See Table 3 ANTIBIOTIC RECOMMENDATIONS BY ANTIBIOTIC on page 6, for lincomycin & clindamycin dilution & administration. 4. Penicillin prophylaxis provides cover against the small but important risk of clostridial infection. 5. Clean-contaminated cancer surgery or other clean-contaminated procedures with the exception of tonsillectomy and functional endoscopic sinus procedures (for which procedures no antimicrobial prophylaxis is recommended). 6. Clean procedures with placement of prosthesis (excludes tympanostomy tubes) do not require metronidazole. 7. Prior to hysterectomy, screening and treatment for bacterial vaginosis (BV) reduces BV-associated cuff infection. Similarly for termination of pregnancy, screening for Chlamydia trachomatis and BV with appropriate treatment, prior to the procedure reduces infectious complications. 8. The value of prophylaxis for the insertion of shunts, ventricular drains or pressure monitors remains unproven and is not recommended. Version One December 2014 Page 4

5 TABLE 2 ANTIBIOTIC PROPHYLAXIS FOR ORTHOPAEDIC PROCEDURES Procedure First Line Second Line Orthopaedics: elective surgery (nontrauma) only if prosthesis inserted. 9 Screen for MRSA (nasal swab). 10 Orthopaedics: non-elective (trauma) Cephazolin 2g IV (child: 25 mg/kg up to 2g) AND (if MRSA positive) Cephazolin 2g IV (child: 25 mg/kg up to 2g) AND (if MRSA positive) (major beta lactam allergy) If a fracture is debrided, fixed and closed within 6 hours then no extra prophylaxis is required. Otherwise, presumptive therapy for early infection (not yet clinically overt) is indicated (see below). For this guideline, the presence of an external fixator is not considered to represent an open wound. Gustillo type Size of wound Duration of antibiotics I <1 cm 24 hours after wound closure or 2 II 1 3 cm 24 hours after wound closure or 3 III > 3 cm 24 hours after wound closure or 5 IIIA Bone coverable. 24 hours after wound closure or 5 IIIB IIIC Other multi-trauma cases Including brain injury, base of skull fracture and CSF pressure monitored case. Bone not coverable. Arterial injury, bone not coverable 24 hours after procedure. 9 Prophylaxis is given for prosthetic joint and other procedures involving insertion of prosthetic/foreign material. Arthroscopy does not require antibiotic prophylaxis. If joint infection is suspected prior to surgery and diagnostic specimens are required, delay administration in hip prostheses until after tissue samples taken. In knee operations, administer prophylaxis at the time of tourniquet removal. 10 Preoperative Staphylococus aureus (MRSA) nasal screening is indicated for prosthetic hip and knee joint surgery. Glycopeptide (teicoplanin) surgical prophylaxis is required for MRSA carriers. Version One December 2014 Page 5

6 TABLE 3 ANTIBIOTIC RECOMMENDATIONS BY ANTIBIOTIC Cephazolin Cefalothin (Cefalotin) Cefotaxime, ceftriaxone & ceftazidime Clindamycin Gentamicin Lincomycin Metronidazole Teicoplanin Vancomycin 2g IV is recommended for all adult patients. No longer recommended for prophylaxis in view of its inferior pharmacokinetics for this purpose. There is no indication for any of these antibiotics for surgical prophylaxis. They may provide inferior coverage for Gram positive microorganisms and their broad Gram negative coverage promotes unacceptable antimicrobial resistance. Injection should be diluted in no less than 50mL. Infuse over at least 20 minutes. Dose as indicated above. Dose according to actual body weight up to maximum of 360mg. Intravenous dosing may be by slow injection over 5 minutes. Avoid gentamicin if significant pre-existing conductive hearing or vestibular problem (including past history of Ménière s disease). Must be diluted to at least 100mL and infuse over 60 minutes. Appropriate dilution and infusion rate are the key to preventing cardiopulmonary infusion reactions (e.g. hypotension). 500mg IV infusion over minutes ending the infusion at the time of induction. Teicoplanin is now the preferred glycopeptide as it can be given by slow injection over 5 minutes, fifteen to thirty minutes before surgical incision. However the cost of teicoplanin is considerably more than vancomycin. Vancomycin should be used if teicoplanin is not available (see immediately below). 25mg/kg (based on actual body weight) up to 1.5 g infused at a maximum rate of 10 mg/minute to prevent red man syndrome. Due to its long infusion time, vancomycin should ideally be commenced between 30 to 120 minutes before surgical incision, ending the infusion 15 to 30 minutes PRIOR to anaesthetic induction. To co-ordinate this, vancomycin infusion must begin when the patient is on the ward. If gentamicin is also indicated, this can be given 15 to 30 minutes before surgical incision. Version One December 2014 Page 6

7 IMPLEMENTATION PLAN Surgical Antibiotic Prophylaxis HNELHD CG 14_35 The District Executive will ensure that all Health Service Managers (HSMs) receive this Guideline. The HNE LHD Quality Use of Medicines Committee (HNE LHD QUMC) will disseminate this Guideline to all Quality Use of Medicine Committees (QUMCs), Drugs & Therapeutics Committees (DTCs) or equivalent in the District. The QUMCs, DTCs etc. & the HSMs will disseminate this Guideline to the lead person for antimicrobial stewardship implementation designated by the HSM of each Health Service. The lead person for antimicrobial stewardship implementation at each site or the HSM (if the HSM has not designated a lead person) will disseminate this Guideline to all surgical, orthopaedic & anaesthetic practitioners & services. Intensive care rounds conducted at least weekly by clinical microbiology & infectious diseases at all District sites should assess all trauma and neurosurgical cases for duration of prophylaxis. Intensivists should apply this Guideline to truncate prolonged prophylaxis. Junior Medical Officer (JMOs), Specialists, Visiting Medical Officers (VMOs) and General Practitioners will receive education from Pharmacy, Infectious Diseases & Clinical Microbiology at orientation & other educational opportunities. The Guideline will be included on the HNE LHD QUM app at HNE LHD Antimicrobial Working Party is responsible for updating this Guideline. MONITORING AND AUDITING PLAN Surgical Prophylaxis audits by Pharmacy will assess perioperative timeliness, correct agent and correct dose. Reports will be tabled at QUMCs, DTCs & equivalent meetings. Timeout procedure will include assessment of surgical prophylaxis completion The designated lead for antimicrobial stewardship at each health service or the HSM is responsible for co-ordinating these audits. CONSULTATION WITH KEY STAKEHOLDERS Surgical Departments & District surgical services Orthopaedic Departments Anaesthetic services Paediatric Surgeons Infectious Diseases and Immunology Pathology North Microbiology District Antimicrobial Working Party Clinical Governance REFERENCES Dale W. Bratzler et al. Clinical practice guidelines for antimicrobial prophylaxis in surgery. American Journal of Health-System Pharmacy. 2013; 70: (ASHP Report) Antibiotic Expert Group. Therapeutic Guidelines: Antibiotic. Version15.Melbourne: Therapeutic Guidelines Limited; FEEDBACK Any feedback on this document should be sent to the Contact Officer listed on the front page. Version One December 2014 Page 7