SURGICAL ANTIBIOTIC PROPHYLAXIS GUIDELINES WITHIN ORTHOPAEDIC SURGERY FOR ADULT PATIENTS Full Title of Guideline: Author (include email and role): Division & Speciality: Scope (Target audience, state if Trust wide): Review date (when this version goes out of date): Explicit definition of patient group to which it applies (e.g. inclusion and exclusion criteria, diagnosis): Changes from previous version (not applicable if this is a new guideline, enter below if extensive): Summary of evidence base this guideline has been created from: SURGICAL ANTIBIOTIC PROPHYLAXIS GUIDELINES WITHIN ORTHOPAEDIC SURGERY FOR ADULT PATIENTS Dr Sue Snape (Consultant Microbiologist) Dr Lakshmipathy Purushothaman Head of service for Trauma Tim Hills Lead Pharmacist Antimicrobials and infection control Trauma/elective orthopaedics - MSKN Prescribers, nurses and pharmacists caring for patients undergoing orthopaedic operations. January 2021 Adult patients undergoing orthopaedic surgical procedures outlined within the guideline. Nil changes National SIGN guidelines on Surgical Antibiotic Prophylaxis Guideline 104 available from www.sign.ac.uk. April 2014. British Orthopaedic Association. Open fractures of the lower limb a short guide. Sept 2009. Recommended best practice based on clinical experience of guideline developers. This guideline has been registered with the trust. However, clinical guidelines are guidelines only. The interpretation and application of clinical guidelines will remain the responsibility of the individual clinician. If in doubt contact a senior colleague or expert. Caution is advised when using guidelines after the review date or outside of the Trust. Nottingham Antibiotic Guidelines Committee Page 1 of 7 Review: Jan 2021
Contents SURGICAL ANTIBIOTIC PROPHYLAXIS GUIDELINES WITHIN ORTHOPAEDIC SURGERY FOR ADULT PATIENTS 1. Introduction 3 Page 2. Risk of Infection 3 3. Antibiotic Prophylaxis - Principles 4 3.1 Timing for administration 3.2 Additional intra-operative doses 3.3 Post-operative antibiotic prophylaxis 4. Orthopaedic Surgery Antibiotic Prophylaxis Regimens 5 4.1 Standard regimen 4.2 Alternative regimen for patients with mild allergy to Penicillins (i.e. no 4.3 Alternative regimen for patients with severe allergy to Penicillins or allergy to Cephalosporins or known MRSA 5. Orthopaedic Antibiotic Guideline for Open Fractures 6 5.1 Standard regimen 5.2 Alternative regimen for patients with mild allergy to Penicillins (i.e. no 5.3 Alternative regimen for patients with severe allergy to Penicillins or allergy to Cephalosporins 5.4 Standard regimen if wound grossly contaminated 7 5.5 Alternative regimen for patients with Penicillin allergy if wound grossly contaminated Nottingham Antibiotic Guidelines Committee Page 2 of 7 Review: Jan 2021
1. Introduction Surgical site infection (SSI) is one of the most common healthcare associated infections resulting in an average additional hospital stay of 6.5 days per case. In operations with a higher risk of infection (e.g. clean-contaminated surgery), perioperative antibiotic prophylaxis has been shown to lower the incidence of infection. High antibiotic levels at the site of incision for the duration of the operation are essential for effective prophylaxis. Studies have shown that the administration of prophylactic antibiotics after wound closure do not reduce infection rates further and can result in harm (see below). Administration of antibiotics also increases the prevalence of antibiotic-resistant bacteria and predisposes the patient to infection with organisms such as Clostridium difficile, a cause of antibiotic-associated colitis. This risk increases with the duration that antibiotics are given for and is higher in the elderly, immunosuppressed, patients who have a prolonged hospital stay or who have received gastro-intestinal surgery. 2. Risk of Infection The risk of SSI depends on a number of factors; these can be related to the patient or the operation and some of them are modifiable (see table 1). Table 1: Risk factors that increase the rate of SSI Patient Operation Age Nutritional status Diabetes Smoking Obesity Coexistent infections at a remote body site Colonisation with microorganisms (e.g. Staph. aureus) Immunosuppression (inc. taking glucocorticoid steroids or immunosuppressant drugs) Length of preoperative stay Co-existent severe disease that either limits activity or is incapacitating Malignancy Duration of surgical scrub / Skin antisepsis Preoperative shaving / preoperative skin prep. Length of operation Appropriate antimicrobial prophylaxis Operating room ventilation Inadequate sterilisation of instruments Foreign material in the surgical site Surgical drains Surgical technique inc. haemostasis, poor closure, tissue trauma Post-operative hypothermia The risk is also related to the amount of contamination with microorganisms the so-called class of the operation (see table 2). Table 2: Definitions of operation class Class Clean 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. Clean-contaminated Contaminated Dirty 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. Nottingham Antibiotic Guidelines Committee Page 3 of 7 Review: Jan 2021
Peri-operative antibiotics are generally recommended for clean-contaminated or contaminated operations. Dirty operations (e.g. open fracture > 4 hours old) generally require treatment with antibiotics (see section 5). 3. Antibiotic Prophylaxis 3.1 Timing for administration Antibiotic prophylaxis administered too early or too late increases the risk of SSI. Studies suggest that antibiotics are most effective when given 60 minutes before skin is incised. The pragmatic approach is to administer prophylaxis towards the end of induction and ensure that surgery starts within 60 minutes of this time wherever possible. It is important that antibiotics are fully administered prior to tourniquet inflation (if used). 3.2 Additional intra-operative doses High antibiotic levels, at the site of incision, for the duration of the operation, are essential for effective prophylaxis. Patient s who experience major blood loss (greater than 1500ml) should have fluid resuscitation, followed by re-dosing with the recommend prophylaxis regimen for that operation (see section 4 and 5). For operations lasting > 4 hours re-dosing may be necessary (see table 3) Common Antibiotics Cefuroxime Ciprofloxacin Flucloxacillin Gentamicin Piperacillin / Tazobactam Metronidazole Recommended re-dosing interval/dose to give 4 hours, give 1.5g IV 8 hours, give 400mg IV 3 hours, give 1g IV re-dosing not recommended 2 hours, give 4.5g IV 8 hours, give 500mg IV Teicoplanin re-dosing not recommended Table 3: Recommend re-dosing interval 3.3 Post-operative antibiotic prophylaxis In arthroplasty, there is evidence from a very large observational cohort that 24 hours of antimicrobial perioperative prophylaxis is associated with lower rates of re-operation than a single dose. This has been extrapolated to other orthopaedic operations involving internal fixation. Studies have shown that giving additional antibiotic prophylaxis does not reduce infection rates further, but increases the prevalence of antibiotic-resistant bacteria and predisposes the patient to infection with organisms such as Clostridium difficile, a cause of antibiotic-associated colitis. Antibiotics beyond 24 hours must only be given to treat active/on-going infection unless specifically recommended against the surgical procedure (e.g. see open fracture guidance below). Nottingham Antibiotic Guidelines Committee Page 4 of 7 Review: Jan 2021
4. Orthopaedic Antibiotic Prophylaxis Regimens 4.1 Standard regimens Clean surgery without the insertion of prosthetic material No antibiotic prophylaxis required. Insertion of joint prosthetics / internal fixation Flucloxacillin 2g IV + Gentamicin 2mg/kg IV at induction. Plus Flucloxacillin 1g IV at 3 hours post-induction if still intra-operative or 6 hours postinduction if operation finished. Plus Flucloxacillin 1g IV, 12 hours post-induction*. Plus Flucloxacillin 1g IV 18 hours post-induction*. *The doses of Flucloxacillin 1g IV at 12 and 18 hours post-induction are not required in day-case patients with simple fractures of the radius or ankle. 4.2 Alternative regimen for patients with mild allergy to penicillins (i.e. no Clean surgery without the insertion of prosthetic material No antibiotic prophylaxis required. Insertion of joint prosthetics / internal fixation Cefuroxime 1.5g IV + Gentamicin 2mg/kg IV at induction. Additional doses for prolonged procedures/ major blood loss (see 3.2): Cefuroxime 1.5g IV at 4 hours post-induction if still intra-operative or if there is major blood loss (>1500mls). No post-operative antibiotic prophylaxis is given. 4.3 Alternative regimen for patients with severe allergy to penicillins, allergy to cephalosporins or known MRSA Clean surgery without the insertion of prosthetic material No antibiotic prophylaxis required. Insertion of joint prosthetics / internal fixation Teicoplanin IV 800mg at induction + Gentamicin 2mg/kg IV at induction. No further post-operative doses required. Nottingham Antibiotic Guidelines Committee Page 5 of 7 Review: Jan 2021
5. Orthopaedic Antibiotic Guideline for Open Fractures Regimens for wounds that are not grossly contaminated If multiple operations required due to extensive fractures please discuss antibiotic treatment with microbiology in working hours. 5.1 Standard regimen As soon as possible after the injury, and certainly within three hours start: Co-amoxiclav IV 1.2g 8 hourly. Co-amoxiclav IV 1.2g + Gentamicin IV 2mg/kg at induction. Continue Co-amoxiclav IV 1.2g 8 hourly until soft tissue closure or for a maximum of 72 hours, whichever is sooner. 5.2 Alternative regimen for patients with mild allergy to penicillins (i.e. no As soon as possible after the injury, and certainly within three hours start: Cefuroxime IV 1.5g 8 hourly. Cefuroxime IV 1.5g + Gentamicin IV 2mg/kg at induction. Continue Cefuroxime IV 1.5g 8 hourly until soft tissue closure or for a maximum of 72 hours, whichever is sooner. 5.3 Alternative regimen for patients with severe penicillin allergy (e.g. anaphylaxis, immediate onset urticarial or angioedema) or allergy to cephalosporins As soon as possible after the injury, and certainly within three hours start: Clindamycin IV 600mg 6 hourly. Clindamycin IV 600mg + Gentamicin IV 2mg/kg at induction. Continue Clindamycin IV 600mg 6 hourly until soft tissue closure or for a maximum of 72 hours, whichever is sooner. Nottingham Antibiotic Guidelines Committee Page 6 of 7 Review: Jan 2021
Regimens for wounds that are grossly contaminated If multiple operations required due to extensive fractures please discuss antibiotic treatment with microbiology in working hours. 5.4 Standard regimen if wound grossly contaminated Start Piperacillin / Tazobactam IV 4.5g 8 hourly as soon as possible after the injury, and certainly within three hours. Piperacillin / Tazobactam IV 4.5g + Gentamicin IV 2mg/kg at induction. Continue Piperacillin / Tazobactam IV 4.5g 8 hourly until soft tissue closure or for a maximum of 72 hours, whichever is sooner. 5.5 Alternative regimen for patients with penicillin allergy if wound grossly contaminated Start: Ciprofloxacin IV 400mg 12 hourly + Metronidazole IV 500mg 8 hourly + Teicoplanin IV 800mg 12 hourly for 3 doses then 800mg OD Give as soon as possible after the injury, and certainly within three hours. Ciprofloxacin IV 400mg (if not already given within the previous 4 hours) + Gentamicin IV 2mg/kg at induction. No extra doses of Metronidazole and Teicoplanin required. Continue Ciprofloxacin, Metronidazole and Teicoplanin (as above) until soft tissue closure or for a maximum of 72 hours, whichever is sooner. if not already given. Nottingham Antibiotic Guidelines Committee Page 7 of 7 Review: Jan 2021