Title of Guideline (must include the word Guideline (not protocol, policy, procedure etc) Author: Contact Name and Job Title Directorate & Speciality Date of submission June 2015 Explicit definition of patient group to which it applies (e.g. inclusion and exclusion criteria, diagnosis) Version 3.0 If this version supersedes another clinical guideline please be explicit about which guideline it replaces including version number. Changes from previous guideline Statement of the evidence base of the guideline has the guideline been peer reviewed by colleagues? Evidence base: (1-5) 1a 1b 2a 2b meta analysis of randomised controlled trials at least one randomised controlled trial at least one well-designed controlled study without randomisation at least one other type of well-designed quasiexperimental study 3 well designed non-experimental descriptive studies (ie comparative / correlation and case studies) 4 expert committee reports or opinions and / or clinical experiences of respected authorities 5 recommended best practise based on the clinical experience of the guideline developer Surgical Antibiotic Prophylaxis Guidelines for Adult Patients within Maxillofacial and ENT. Sarah Partridge (Antimicrobial Pharmacist) Miss Liza Watson (Associate Specialist Oral & Maxillofacial Surgery) Mr Andrew Marshall (ENT Consultant) Dr Vivienne Weston (Consultant Microbiologist). Diagnostics and Clinical Support, Microbiology Applies to: Adult patients undergoing ENT and Maxillofacial surgical procedures outlined within the guideline Excludes: Paediatrics. Replaces previous guideline no.1875 Timing of administration changed to 60 minutes. Teicoplanin doses increased to 800mg. Cefuroxime re-dose increased to 1.5g. Evidence base 1a and 4+5 SIGN 104: Antibiotic prophylaxis in surgery. July 2008, updated April 2014. Available online: http://www.sign.ac.uk/ (accessed 29.05.2015) Recommended best practice based on clinical experience of guideline developers Consultation Process NUH Antimicrobial Guidelines Committee Ratified by: Date: Target audience Review date: June 2018 NUH Antimicrobial Guidelines Committee Prescribers, trained nurses and pharmacists. 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. Nottingham Antibiotic Guidelines Committee Page 1 of 16 Review: June 2018
Surgical Antibiotic Prophylaxis Guidelines for Adult Patients within Maxillofacial and ENT Contents Page 1. Introduction 4 2. Risk of infection 4 3. Antibiotic Prophylaxis Principles 5 3.1 Timing for Administration 5 5 3.2 Additional Intra-operative doses 3.3 Post-operative antibiotic prophylaxis 5 4. Summary Table for ENT/ Maxillofacial Antibiotic Prophylaxis Regimens in patients. 6 Nottingham Antibiotic Guidelines Committee Page 2 of 16 Review: June 2018
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), peri-operative 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 Colonization with microorganisms (e.g. Staph. aureus) Immunosuppression (inc. taking glucocorticoid steroids or immunosuppressant drugs) Length of preoperative stay Coexistent 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 sterilization of instruments Foreign material in the surgical site Surgical drains Surgical technique inc. haemostasis, poor closure, tissue trauma Post-operative hypothermia Nottingham Antibiotic Guidelines Committee Page 3 of 16 Review: June 2018
The risk is also related to the amount of contamination with microorganisms the socalled class of the operation (see table 2): Table 2: Definitions of operation class. Class Definition Clean Clean-contaminated Contaminated Dirty 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. Peri-operative antibiotics are generally recommended for clean-contaminated or contaminated operations. Dirty operations (e.g. perforated appendectomy) generally require treatment with antibiotics. 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 and ensure that surgery starts within 60 minutes of this time wherever possible. 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 recommended prophylaxis regimen for that operation (see section 4). For operations lasting more than 4 hours re-dosing may be necessary (see table 3) Antibiotic Amoxicillin Cefuroxime Clindamycin Co-amoxiclav Gentamicin Metronidazole Teicoplanin Recommended re-dosing interval/dose to give 4 hours, give 1g IV 4 hours, give 1.5g IV 4 hours give 600mg IV 4 hours, give 1.2g IV re-dosing not recommended 8 hours, give 500mg IV re-dosing not recommended Vancomycin re-dosing not recommended Table 3: Recommend re-dosing interval Nottingham Antibiotic Guidelines Committee Page 4 of 16 Review: June 2018
3.3 Post-operative antibiotic prophylaxis Studies have shown that giving additional antibiotic prophylaxis after wound closure does not reduce infection rates further. Post-operative antibiotics should only be given to treat active/on-going infection (e.g. dental abscess) unless specifically recommended against the surgical procedure (see section 4). Nottingham Antibiotic Guidelines Committee Page 5 of 16 Review: June 2018
4. Summary Table for Maxillofacial / ENT Antibiotic Prophylaxis Regimens in Patients Procedure Head and Neck Surgery - Oral & Facial 0.2% Chlorhexidine Gluconate mouth rinse to be given pre-op for all procedures involving mucosal breach and advised TDS post-op 3 days (check with Consultant before prescribing chlorhexidine to Oncology cases having major resection / free flap reconstruction). Dentoalveolar Routine - Extraction / surgical removal of teeth. Complex - Large cysts, Closure of Oro-antral fistula prophylaxis routinely. Amoxicillin 1g 500mg on routinely. routinely. prophylaxis routinely. 500mg on If previous radiotherapy or bisphosphonates: use Clindamycin 600mg (PO) 1 hour pre-op for local anaesthetic cases; (IV) on for general anaesthetic. Treat with antibiotics if active infection. Nottingham Antibiotic Guidelines Committee Page 6 of 16 Review: June 2018
Procedure Open reduction and internal fixation of fractures (ORIF): No prosthesis e.g. Simple elevation of Zygoma If a previous course of oral co-amoxiclav has been given as conservative treatment use Cefuroxime and metronidazole prophylaxis regimen as in mild penicillin allergy Cefuroxime 1500mg Metronidazole 500mg IV at If a previous course of oral cefalexin and metronidazole has been given as conservative treatment use IV clindamycin prophylaxis regimen as in severe penicillin allergy If a previous course of oral clindamycin has been given as conservative treatment use IV teicoplanin and metronidazole prophylaxis regimen as in previous/ 500mg on Refers to mandible, maxilla, Zygoma & Orbital fractures Prosthesis for internal fixation + 2 further doses at 8 and 16 hrs post-op If a previous course of oral co-amoxiclav has been given as conservative treatment use Cefuroxime and metronidazole prophylaxis regimen as in mild penicillin allergy Cefuroxime 1500mg Metronidazole 500mg IV + 2 further doses at 8 and 16 hrs post-op If a previous course of oral cefalexin and metronidazole has been given as conservative treatment use IV clindamycin prophylaxis regimen as in severe penicillin allergy + 3 further doses at 6, 12 and 18 hrs post-op If a previous course of oral clindamycin has been given as conservative treatment use IV teicoplanin and metronidazole prophylaxis regimen as in previous/ 500mg on + 2 further doses of 500mg at 8 and 16 hrs post-op Nottingham Antibiotic Guidelines Committee Page 7 of 16 Review: June 2018
Procedure Open fractures for conservative treatment Facial/Mandibular fracture involving oral /antral mucosal breach (not usually sutured) or Zyg arch/condylar fracture with overlying skin wound Co-amoxiclav 625mg PO TDS for 3 days Cefalexin 500mg TDS PO and Metronidazole 400mg TDS PO for 3 days Clindamycin 450mg QDS PO for 3 days 500mg initially then 400mg TDS PO for 3 days 72 hours or sooner (24hrs) if the only epithelial breach is sutured skin No extra antibiotics for CSF leak Closed Fractures: e.g. Isolated zygomatic arch # for Conservative treatment or elevation ORIF of fractured condylar neck as for TMJ surgery with prosthesis Skin / Mucosal Lacerations Good debridement / irrigation essential. Check tetanus status Check tetanus status Check tetanus status Check tetanus status Nottingham Antibiotic Guidelines Committee Page 8 of 16 Review: June 2018
Procedure Animal Bites As per ED guidelines Antibiotic prophylaxis is recommended for wound <48-72 hours old when risk of infection is high. Co-amoxiclav 625mg PO TDS for 5 days Check tetanus status Consider rabies risk assessment Doxycycline 200mg PO on day 1 then 100mg daily + Metronidazole 400mg PO TDS for 5 days If pregnant use: Azithromycin 500mg PO OD for 3 days + Metronidazole 400mg PO TDS for 5 days Check tetanus status Consider rabies risk assessment Doxycycline 200mg PO on day 1 then 100mg daily + Metronidazole 400mg PO TDS 5 days of each If pregnant use: Azithromycin 500mg PO OD for 3 days + Metronidazole 400mg PO TDS for 5 days Check tetanus status Consider rabies risk assessment Good debridement / irrigation essential. Close if no significant tissue loss. Human Bites As per ED guidelines Antibiotic prophylaxis is recommended for wound <48-72 hours old when risk of infection is high. Co-amoxiclav 625mg PO TDS for 5 days Check need for tetanus/ Hep B / HIV / Hep C prophylaxis, Doxycycline 200mg PO on day 1 then 100mg daily + Metronidazole 400mg PO TDS for 5 days If pregnant use: Azithromycin 500mg PO OD for 3 days + Metronidazole 400mg PO TDS for 5 days Check need for tetanus/ Hep B / HIV / Hep C prophylaxis, Doxycycline 200mg PO on day 1 then 100mg daily + Metronidazole 400mg PO TDS 5 days of each If pregnant use: Azithromycin 500mg PO OD for 3 days + Metronidazole 400mg PO TDS for 5 days Check need for tetanus/ Hep B / HIV / Hep C prophylaxis, Good debridement / irrigation essential. Check with individual consultant re closure. Follow ED guidelines re blood borne infections. Nottingham Antibiotic Guidelines Committee Page 9 of 16 Review: June 2018
Procedure Maxillo-facial Surgical Resections Including freeflaps No prosthesis Prosthetic material used + 2 further doses at 8 and 16 hrs post-op Cefuroxime 1500mg Metronidazole 500mg IV at Cefuroxime 1500mg Metronidazole 500mg IV + 2 further doses at 8 and 16 hrs post-op + 3 further doses at 6, 12 and 18 hrs post-op 500mg on 500mg on + 2 further doses of 500mg at 8 and 16 hrs post-op If procedure is prolonged (>4hrs) or blood loss > 1500ml re-dosing of antibiotics may be appropriate. (Increased risk of contamination) See table 3, page 4. Orthognathic surgery + 2 further doses at 8 and 16 hrs post-op Cefuroxime 1500mg Metronidazole 500mg IV at + 2 further doses at 8 and 16 hrs post-op + 3 further doses at 6, 12 and 18 hrs post-op 500mg on + 2 further doses of 500mg at 8 and 16 hrs post-op Alveolar bone grafting (Intra-oral) No prosthesis e.g. Secondary cleft repair Cefuroxime 1500mg Metronidazole 500mg IV at 500mg on 5 days oral post operation cover is given if there is limited coverage over a bone graft. Nottingham Antibiotic Guidelines Committee Page 10 of 16 Review: June 2018
Procedure Insertion of prosthesis e.g. Dental implants, screws,goretex + 2 further doses at 8 and 16 hrs post-op Cefuroxime 1500mg Metronidazole 500mg IV + 2 further doses at 8 and 16 hrs post-op + 3 further doses at 6, 12 and 18 hrs post-op 500mg on + 2 further post-op doses of 500mg at 8 and 16 hrs post-op Temporomandibular joint surgery Clean + no prosthesis e.g. Eminectomy, Arthroscopy Insertion of prosthesis e.g. TJR Co-amoxiclav 1.2g IV at + 2 further doses at 8 and 16 hrs post-op Cefuroxime 1500mg Metronidazole 500mg IV + 2 further doses at 8 and 16 hrs post-op + 3 further doses at 6, 12 and 18 hrs post-op 500mg on + 2 further post-op doses of 500mg at 8 and 16 hrs post-op Nottingham Antibiotic Guidelines Committee Page 11 of 16 Review: June 2018
Procedure HEAD AND NECK SURGERY - THROAT Tonsillectomy Adenoidectomy (by curettage) Clean head and neck surgery (no mucosal breach) including : Stapedectomy, Parotidectomy, Thyroidectomy, Bilateral neck dissection Major head and neck surgery (with mucosal breach) Cefuroxime 1500mg Metronidazole 500mg IV at 500mg on If procedure is prolonged (>4 hours) re-dosing of antibiotics maybe appropriate (see table 3, page 4). Salivary gland surgery Contamination unlikely Possible contamination Cefuroxime 1500mg Metronidazole 500mg IV at 500mg on Nottingham Antibiotic Guidelines Committee Page 12 of 16 Review: June 2018
Procedure NASAL SURGERY Routine nose, sinus and endoscopic nasal surgery If active infection, treat with appropriate antibiotics. Review choice with microbiology results. Septorhinoplasty Routine procedures Complex procedures e.g. free cartilage replacement Cefuroxime 1500mg Metronidazole 500mg IV at 500mg on Graft + 2 further doses at 8 and 16 hrs post-op Cefuroxime 1500mg Metronidazole 500mg IV + 2 further doses at 8 and 16 hrs post-op + 3 further doses at 6, 12 and 18 hrs post-op 500mg on + 2 further doses of 500mg at 8 and 16 hrs post-op Nottingham Antibiotic Guidelines Committee Page 13 of 16 Review: June 2018
Procedure Closure of CSF leak with intranasal pathology / pack in position + oral co-amoxiclav 625mg TDS for 3 days Cefuroxime 1.5mg Metronidazole 500mg IV at + oral cefalexin 500mg TDS and metronidazole 400mg TDS for 3 days + oral clindamycin 450mg QDS for 3 days 500mg on + oral metronidazole 400mg TDS for 3 days EAR SURGERY Cochlear Implants Cefuroxime 1.5g IV + 2 further 750mg doses at 8 and 16 hrs post-op Cefuroxime 1.5g IV + 2 further 750mg post-op doses at 8 and 16 hrs postop + 3 further post-op doses of oral clindamycin 600mg at 6, 12 and 18 hrs IV on Post-op doses are not given to patients attending for day case surgery. Mastoidectomy Grommet Insertion Single dose of Ciprofloxacin eye drops (unlicensed) in ear during procedure. Single dose of Ciprofloxacin eye drops (unlicensed) in ear during procedure. Single dose of Ciprofloxacin eye drops (unlicensed) in ear during procedure. Nottingham Antibiotic Guidelines Committee Page 14 of 16 Review: June 2018
Equality Impact Assessment Report 1. Name of Policy or Service Response to external best practice policy 2. Responsible Manager Annette Clarkson 3. Name of person Completing EIA Sarah Partridge 4. Date EIA Completed 01/07/2015 5. Description and Aims of Policy/Service The clinical guidelines procedure has been written to provide a summary of the recommended antibiotic prophylaxis for all adult patients undergoing a thoracic surgical procedure including advice on those patients at risk of endocarditis. 6. Brief Summary of Research and Relevant Data There is no research or relevant data at the present time. 7. Methods and Outcome of Consultation Consultations have been carried out with the following: NUH antimicrobial guidelines committee. Comments from the above consultations have been received and incorporated where appropriate. Nottingham Antibiotic Guidelines Committee Page 15 of 16 Review: June 2018
8. Results of Initial Screening or Full Equality Impact Assessment: Equality Group Age Assessment of Impact Gender Race Sexual Orientation Religion or belief Disability Dignity and Human Rights Working Patterns Social Deprivation 9. Decisions and/or Recommendations (including supporting rationale) From the information contained in the procedure, and following the initial screening, it is my decision that a full assessment is not at the present time. 10. Equality Action Plan (if ) Not applicable. 11. Monitoring and Review Arrangements Review July 2018 Nottingham Antibiotic Guidelines Committee Page 16 of 16 Review: June 2018