Document type: Antibiotic Prophylaxis in Adult Orthopaedic Surgery Version: 2.0 Author (name): Author (designation): Validated by Formulary/prescribing guideline Dr Celia Chu, Dr Katy Edwards, Dr Pradeep Subudhi, Consultant Microbiologists Samim Patel, Antimicrobial Lead Pharmacist As above Date validated 03.02.2016 Ratified by: Date ratified: 18.02.2016 Name of responsible committee/individual: Name of Executive Lead (for policies only) Master Document Controller: Antimicrobial Stewardship Committee Drugs & Therapeutics Committee Antimicrobial Stewardship Committee N/A Suzanne Schneider Date uploaded to intranet: March 2016 Key words Review date: Feb 2018 Orthopaedic, surgery, surgical prophylaxis, antibiotic prophylaxis Version control Version Type of Change Date Revisions from previous issues 2.0 Major Feb 2016 Policy incorporated into standard template for surgical prophylaxis to include risk factors, wound classification, aim of antibiotic prophylaxis in surgery and method of administration. Equality Impact Teicoplanin dose increased from 400mg to 600mg in situations for prophylaxis, and from 400mg to 12mg/kg in revision joint replacements until culture results known. Prophylactic Flucloxacillin dose increased to 2g. Clindamycin replaces teicoplanin in penicillin allergy New recommendation for open fracture repair Bolton NHS Foundation Trust strives to ensure equality of opportunity for all service users, local people and the workforce. As an employer and a provider of healthcare Bolton NHS FT aims to ensure that none are placed at a disadvantage as a result of its policies and procedures. This document has therefore been equality impact assessed to ensure fairness and consistency for all those covered by it regardless of their individuality. The results are shown in the Equality Impact Assessment (EIA). Page 1 of 9
. Contents Page 1 Purpose 3 2 Content 2.1 Risk Factors for SSI 2.2 Wound Classification 2.3 Aim of Antibiotic Prophylaxis in Surgery 2.4 Terminology & Definitions 2.5 Method of Antibiotic Administration 2.6 Summary of Recommendations 3 3 4 5 6 7 3 Monitoring 8 4 Appendix 1: References 8 5 Appendix 2: Equality Impact Assessment 9 Page 2 of 9
Purpose The purpose of this document is to make antibiotic recommendations for adult orthopaedic surgical procedures where prophylaxis is supported by the evidence base. The term surgical site infection (SSI) is used to encompass the surgical wound and infections involving the body cavity, bones, joints and other tissues involved in the operation. In procedures that require the insertion of implants or prosthetic devices, the term also encompasses infections associated with such devices. 1 SSI is one of the most common healthcare associated infections (HCAI), with one UK study from 2001 showing the consequences to be an average additional hospital stay of 6.5 days at a cost of 3,246 per patient. The consequences for the patient include a longer and more painful stay in hospital. 1 Content 2.1 Risk Factors for SSI 1 - These can be classified patient or operation characteristics: Patient Operation Extremes of age Length of surgical scrub Poor nutritional state Skin antisepsis Obesity Pre-operative shaving Diabetes mellitus Pre-operative skin preparation Smoking Length of operation Co-existing infection at other sites Antimicrobial prophylaxis Bacterial colonisation Operating theatre ventilation Immunosuppression Inadequate instrument sterilisation Prolonged postoperative stay Foreign material in surgical site Surgical drains Surgical techniques Postoperative hypothermia 2.2 Wound Classification 1 : Operations can be categorised into four classes, with an increasing incidence of bacterial contamination and subsequent incidence of SSI: Class Clean Cleancontaminated Contaminated Dirty Definition Operations in which no inflammation is encountered and the respiratory, alimentary or genitourinary tracts are not entered. There is no break in aseptic operating theatre technique Operations in which the respiratory, alimentary or genitourinary tracts are entered but without significant spillage. Operations where acute inflammation (without pus) is encountered, or where there is visible contamination of the wound. Examples include gross spillage from a hollow viscus during the operation or compound/open injuries operated on within four hours. Operations in the presence of pus, where there is a previously perforated hollow viscus, or compound/open injuries more than four hours old. Page 3 of 9
2.3 Aim of Antibiotic Prophylaxis in Surgery: The aim of antibiotic prophylaxis in surgery is to: Reduce the incidence of SSI by inhibiting growth of contaminating bacteria at the operative site. Utilise antibiotics in a manner that is supported by evidence of effectiveness. Minimise the risk of collateral damage associated with antibiotic use, such as acquisition of HCAI (e.g. Clostridium difficile infection), antibiotic resistance and adverse drug effects. Page 4 of 9
2.4 Terminology and Definitions Choice of Antibiotic Route of Administration Penicillin Allergy Dosage Selection Timing of Administration Duration of prophylaxis Additional dosage during the operation: Surgical prophylaxis for MRSA positive patients Although a wide range of organisms can cause infection in surgical patients, SSI is usually due to a small number of common pathogens. The antibiotics selected for prophylaxis must cover the expected pathogens for that operative site. Prophylactic antibiotics for surgical procedures should be given intravenously Alternative recommendations are provided for patients with penicillin allergy. Patients with a history of anaphylaxis, laryngeal oedema, bronchospasm, hypotension, local swelling, urticaria or rash, occurring immediately after penicillin administration are potentially at increased risk of immediate hypersensitivity to beta-lactams and should not receive prophylaxis with a beta-lactam antibiotic. It is generally accepted as good practice that the dosage of an antibiotic required for prophylaxis is the same as that for treatment of infection. 1 The timing of the first dose in relation to administration is critical. Antibiotic prophylaxis administered too early or too late reduces the efficacy of the antibiotic and may increase the risk of SSI. For surgical procedures, IV antibiotics must be administered to the patient within 60 minutes before the skin is incised and as close to the time of incision as practically possible. A single standard therapeutic dose of antibiotic is sufficient for prophylaxis under most circumstances. For many types of commonly performed surgery, there is consistent evidence that a single dose of antimicrobial with a long enough half-life to achieve activity throughout the operation is adequate. Since prophylaxis must maintain adequate antibiotic levels for the duration of the procedure, additional dosage is recommended in the following circumstances: Where the duration of the procedure is longer than 4 hours and the half-life of the antibiotic administered is 2hours. For the purpose of the antibiotics recommended in this document, this will include flucloxacillin (t1/2 = 1 hour) only. In the event of major intra-operative blood loss (in adults >1500ml). All patients with a positive screen for MRSA should undergo MRSA skin and nasal de-colonisation therapy as per the Trust MRSA policy. For procedures requiring antibiotic prophylaxis, patients with current or previous MRSA colonisation should receive systemic antibiotic prophylaxis even if they have been treated with topical de-colonisation therapy. Teicoplanin IV is recommended as first line therapy in surgical prophylaxis since it may be administrated as a bolus injection. Page 5 of 9
2.5 Method of Antibiotic Administration In order to maximise tissue antibiotic concentration at the point of skin incision, it is recommended that IV antibiotics be administered by the bolus method, where bolus is not contraindicated: Antibiotic IV bolus IV infusion Flucloxacillin 2g Reconstitute each 1g vial with Give as IV bolus 15-20ml WFI Administer 2g over 6 mins Gentamicin Ready diluted over 3-5 mins Give as IV bolus Teicoplanin Piperacillin/tazobactam (Tazocin) 4.5g Reconstitute with WFI provided with vial. 800mg as IV bolus over 3-5 mins 20ml WFI over 3-5 mins >800mg IV infusion in NS or 5% glucose over 60mins Give as IV bolus Key: WFI = Water for Injection, NS = 0.9% sodium chloride Page 6 of 9
Operation Primary joint replacement Hip fracture 1 st line prophylaxis regimen Flucloxacillin 2g IV stat plus gentamicin 3mg/kg IV stat. Teicoplanin 600mg IV stat plus gentamicin 3mg/kg IV stat. 2 nd line regimen: Patients with penicillin allergy Teicoplanin 600mg IV stat plus gentamicin 3mg/kg IV stat. As per 1 st line. History of MRSA colonisation or infection Teicoplanin 600mg IV stat plus gentamicin 3mg/kg IV stat. As per 1 st line. Other comments Open fracture repair Co-amoxiclav 1.2g IV stat Other trauma surgery Teicoplanin 600mg IV stat plus gentamicin 3mg/kg IV stat plus metronidazole 400mg IV stat. Flucloxacillin 2g IV stat. Teicoplanin 600mg IV stat. Co-amoxiclav 1.2g IV stat plus teicoplanin 600mg IV stat Teicoplanin 600mg IV stat. Continue for 72hrs or until skin closure, whichever is soonest. For patients on 2 nd line agents, liaise with microbiology for follow on therapy. Revision joint replacement (organism unknown) Revision joint replacement (organism known) Teicoplanin 12mg/kg (round to the nearest 50mg) IV BD x 3 doses then 12mg/kg IV OD plus Piperacillin/tazobactam (Tazocin) 4.5g IV TDS until culture results known. Discuss with duty Microbiologist. As per 1 st line. Liaise with Consultant Microbiologist prior to surgery. Aim to take 7 deep culture samples prior to antibiotics. Treat as per previous culture and sensitivity results. Consider extra antibiotics in cement. Aim to take 7 deep culture samples prior to antibiotics. Page 7 of 9
Monitoring Area to be monitored Methodology Who Reported to Frequency Compliance with antibiotic recommendations As per the Antimicrobial Stewardship Audit Plan for Bolton FT Under supervision of Consultant Microbiologist / Antimicrobial Pharmacist 1. Antimicrobial Stewardship Committee. 2.Elective Care Governance 3. General Surgical Audit meeting Annual Appendices Appendix 1: References 1. Scottish Intercollegiate Guidelines Network (SIGN 104). Antibiotic Prophylaxis in Surgery. July 2008. Updated April 2014. (sign.ac.uk/guidelines/fulltext/104/index.html). 2. National Institute for Health and Clinical Excellence. Surgical Site Infection: Prevention and Treatment of Surgical Site Infection. NICE Clinical Guideline 74 (www.guidance.nice.org.uk/cg74). 3. Summary of Product Characteristics (www.medicines.org.uk/emc). 4. British National Formulary.68 (www.bnf.org). 5. World Health Organisation Surgical Safety Checklist 2008 (www.who.int/patientsafety/safesurgery/ss_checklist/en/). 6. UK Medicines Information. Medicines Q&A. Q&A 306.3. Can a 2 gram dose of flucloxacillin be given as a slow intravenous injection? 7 th March 2014. Accessed via www.evidence.nhs.uk on 09.12.2015. 7. Imperial College Healthcare NHS Trust. Flucloxacillin Intravenous - Adult. Medusa Injectable Medicines Guide. Accessed via www.injguide.nhs.uk on 09.12.2015. Page 8 of 9
Equality Impact Assessment Tool To be completed and attached to any procedural document when submitted to the appropriate committee for consideration and approval. Yes/ Comments 1. Does the document/guidance affect one group less or more favourably than another on the basis of: Race Ethnic origins (including gypsies and travellers) Nationality Gender (including gender reassignment) Culture Religion or belief Sexual orientation Age Disability - learning disabilities, physical disability, sensory impairment and mental health problems 2. Is there any evidence that some groups are affected differently? 3. If you have identified potential discrimination, are there any valid exceptions, legal and/or justifiable? 4. Is the impact of the document/guidance likely to be negative? 5. If so, can the impact be avoided? N/A 6. What alternative is there to achieving the document/guidance without the impact? 7. Can we reduce the impact by taking different action? N/A N/A If you have identified a potential discriminatory impact of this procedural document, please refer it to the Equality and Diversity Co-ordinator together with any suggestions as to the action required to avoid/reduce this impact. Page 9 of 9