Essential best practices for the prevention of surgical site infection in developing countries Benedetta Allegranzi

Essential best practices for the prevention of surgical site infection in developing countries Benedetta Allegranzi Lead, Clean Care is Safer Care, WHO Service Delivery and Safety, HQ Faculty of Medicine, University of Geneva, Geneva, Switzerland ICAN Conference, 4 November 2014, Harare Zimbabwe

SSI prevention is complex

2014

Recommendations In the 1999 CDC guideline, there are 65 recommendations to control SSI In the new CDC draft guidelines, there are 30 research questions For the new WHO guidelines, there are 22 topics undergoing systematic review

SSI prevention guidelines WHO perspectives Lessons learned from the WHO HH guidelines: need for global approach Valid for any country, but including specific issues depending on regional differences and/or peculiar to low-/middle-income countries Strong component on implementation strategies and surveillance Associated implementation tools Lessons learned from checklists and other programmes

Key Elements in Reducing SSI Courtesy by J. Solomkin

Surgical Care Improvement Project (SCIP)* SCIP INF 1: Prophylactic antibiotic received within one hour prior to surgical incision SCIP INF 2: Prophylactic antibiotic selection for surgical patients SCIP INF 3: Prophylactic antibiotics discontinued within 24 hours after surgery end time (48 hours for cardiac patients) SCIP INF 4: Cardiac surgery patients with controlled 6 a.m. postoperative serum glucose SCIP INF 6: Surgery patients with appropriate hair removal (retired) SCIP INF 7: Colorectal surgery patients with immediate postoperative normothermia *USA, 2002-present Goal: to reduce SSI by 25% by the year 2010

Impact of SCIP (A) odds ratio of SSI and (B) percentage change in SSI 18% decrease in the odds of developing SSI and a cumulative 4% decrease in SSI Munday GS, et al. The American Journal of Surgery, 2014 http://dx.doi.org/10.1016/j.amjsurg.2014.05.005

METHODS Prospective quasi experimental cohort study 4-year (2008-2011) SSI prospective surveillance of colorectal surgery with the introduction of bundle for SSI prevention Bundle: 1) perioperative antibiotic prophylaxis; 2) hair removal before surgery 3) perioperative normothermia; 4) discipline in the operating room 1537 surgical interventions RESULTS SSI decrease over time (borderline significant) Significant SSI decrease (36%) in 2010/2011 after adjustment for confounders SSI patients had a higher likelihood to die within 6 m (Logistic regression analysis) Bundle compliance increase from introduction in 2009 10% to 2011 80% (p< 0.01)

METHODS 34-month, single-institution, blinded randomized controlled trial 211 pts undergoing elective trans-abdominal colorectal surgery included, 197 in ITT analysis Intervention: (1) omission of mechanical bowel preparation; (2) preoperative and intraoperative warming; (3) supplemental oxygen during and immediately after surgery; (4) intraoperative intravenous fluid restriction; (5) use of a surgical wound protector RESULTS SSI overall rate 45% vs 24% in the intervention vs standard arm (P=.003) Main difference was in superficial SSI rate (36% vs 19%, p<0.04) Allocation to the standard arm independent RF for SSI (2.49-fold risk; 95% CI, 1.36-4.56, P=.003) Compliance with the bundle: 99% of subjects received at least 4 of 5 of the bundle interventions. Complete compliance with all of the 5 interventions was 84%

Systematic review on HAI prevention in LMIC - Studies on SSI prevention Total: 84 (infection type most frequently addressed) 59 studies in which the intervention is ANTIMICROBIAL PROPHYLAXIS only 25 studies in which other type IP interventions are included: 6 Surgical technique 5 Post-surgery wound management 3 Skin or surgical site preparation 3 Hand hygiene 2 ATB impregnated materials 2 Multimodal/checklist 1 Guidelines implementation 1 Surveillance and feedback 1 Mechanical bowel preparation 1 Anesthesia J. Hopman, B. Allegranzi et al. ICPIC 2013

Global perspective on SSI

http://www.who.int/patientsafety/safesurgery/en/ Haynes et al. NEJM 2009; 360:491-9.

The Checklist was piloted in 8 cities PAHO I Toronto, Canada EURO London, UK EMRO Amman, Jordan PAHO II WPRO I Manila, Philippines Seattle, USA AFRO Ifakara, Tanzania SEARO New Delhi, India WPRO II Auckland, NZ

Results All Sites Baseline Checklist P value Cases 3733 3955 - Death* 1.5% 0.8% 0.003 Any Complication** 11.0% 7.0% <0.001 SSI 6.2% 3.4% <0.001 Unplanned Reoperation 2.4% 1.8% 0.047 *Significant death rate reduction only in low/middle-income countries (p=0.006) **Significant complication rate reduction in both high-income and low/middle-income countries Haynes et al. New England Journal of Medicine 2009; 360:491-9.

Changes in safety attitudes following the checklist implementation Before/after survey Modified Safety Attitudes Questionnaire (SAQ) 7 sites Haynes et al. BMJ Qual Saf 2011;20:102e107 Degree of improvement of mean SAQ score correlated with a reduction in postoperative complication rates (R=0.7143, p=0.0381) Implementation and use of the checklist is a cost saving quality improvement strategy.

Vats A et al. BMJ 2010

Surgical Unit-based Safety Programme (SUSP) Patient safety climate improvement (CUSP): Science of safety education Staff safety assessment Leadership Learning from defects Team work & communications + + Safe Surgery Checklist Infection prevention & control Best practices Improvement of the patient safety climate Reduction of: Surgical site infections Surgical complications

The Vision of CUSP The Comprehensive Unit-based Safety Program (CUSP) is designed to: Improve patient safety awareness and systems thinking at the unit level Mobilize staff to identify and resolve patient safety issues Create a patient safety partnership between executives and frontline caregivers Provide tools to help CUSP teams investigate and learn from defects and improve teamwork and safety culture

SUSP pilot study Before/after study in colorectal surgery Intervention: CUSP + standardization of skin preparation; administration of preoperative chlorhexidine showers; selective elimination of mechanical bowel preparation; warming of patients in the preanesthesia area; adoption of enhanced sterile techniques for skin and fascial closure; addressing previously unrecognized lapses in antibiotic prophylaxis. Results: mean SSI rate decrease (from 27.3% to 18.2%), 33.3% (95% CI, 9 58%; p=0.05) Wick EC, et al. J Am Coll Surg 2012

Technical versus Adaptive Technical Specific actions Protocols Procedures Adaptive Behaviours Attitudes Values Beliefs WHAT WE DO HOW WE DO IT

Safety culture Risk is acknowledged by the organisation, incl SSI Non-punitive approach to incidents Collaboration across the ranks Resources are allocated to safety Ultimate aim to make safety an integral part of everything we do

Tools for adaptive work Science of safety video Hospital survey of patient safety Executive engagement and walk around Staff safety assessment Barrier identification and mitigation Learning from defects

KIJABE HOSPITAL, KENYA

HSOPS results: Mistakes blamed on an individual Page 27

HSOPS results Staff suffer in silence for fear of victimization if they voice concerns Many staff feel incident reports are for intimidation and victimization because those who write go through that Leaders do not have time to listen to us but blame us Ward meetings should be held regularly for an improved patient care Resource constraints limit effective system optimization for patient safety and reporting of adverse events There is need for a well- organised system of monitoring patient safety issues and reporting, analyzing and feedback of events or errors Page 28

Identify at least one actionable idea to improve unit results in this area Create a culture to build trust between the senior and the front line staff Organize focus groups for leaders to reflect on the concepts of "leadership" and "followership" (challenge them to understand what type of leaders they are) Include concepts on "leadership" and "followership" in the safety culture presentations Organize events and use opportunities to effectively create the team work and spirit

An actual case at Kijabe...

SSI prevention activities Infection control measures Patient pre-operative bathing Hair removal (not necessary or with clippers) Optimization of surgical site skin preparation Optimization of surgical hand preparation Optimization of surgical antibiotic prophylaxis (timing, dose, type of ATB, re-dosing) Discipline in the OR (limiting number of people and door opening during operation) 33

Available tools Set of updated presentations (main topics: science of safety, epidemiology of SSI, interventions to reduce SSI) Updated Fact Sheets Poster on SUSP IPC measures Pocket leaflet Poster on handrubbing technique

SUSP tools and WHO checklist Page 35

Pocket leaflet

Intervention phase Printed learning materials...... and training sessions

Patient preparation for surgery Intervention steps 1. Pre-operative bathing (bath or shower) Use soap, ideally antimicrobial soap Ideally 1-2 hours before the operation CDC 2013 - Require patients to shower or bathe (full body) with either soap (antimicrobial or non-antimicrobial) or an antiseptic agent on at least the night before the operative day (Category IB) Preoperative bathing or showering with skin antiseptics to prevent surgical site infection Webster J, Cochrane DSR 2012

Example 1 of Kijabe approach to technical elements of SUSP intervention identifying problems +solutions 1. Patient pre-operative bathing Challenges Cost Patient acceptability to change soap Bathing times not linked to time of surgery. Nurses fetching hot water for bedside bathing Interventions Sourced for fair priced soap Did a survey for tolerability to new soap. Well received by patients SOP created and nurses educated Instant showers to lessen work

Antiseptic soap survey

Discipline in the OR 1. Use adequate attire and maximum asepsis 2. Organization & planning: make sure that all the equipment needed is in the OR before starting 3. Limit the number of people in the OR to those essential to the operation only 4. If students, limit the number and make sure they are trained according to the asepsis rules 5. Keep door and windows closed during the operation Page 43

Example 2 of Kijabe approach to technical elements of SUSP intervention identifying problems +solutions 6. Discipline in the OR - limiting number of people and door opening during operations Challenges Too many door openings during cases Posters and barrier notices Staff education Phones in every theater room for communication to avoid unnecessary movement Standardized protocols/equipment for every case. Carry out internal survey

Antibiotic prophylaxis best practices Protocols according to most frequent pathogens and ideally, local resistance patterns Correct pre-operative administration timing: 60 minutes before surgical incision. Correct antibiotic type according to the procedure and patient history (of allergy or severe adverse events) Correct dose and intraoperative redosing: Standardized doses should be used Increased doses based on patient weight According to the antibiotic type, doses should be repeated during the operation at specific time intervals (see table) if the duration of the procedure is prolonged or if excessive blood loss (e.g., >1500 ml) or extensive burns. Appropriate discontinuation after surgery: single dose or duration of less than 24 hours.

Procedure Drug/dosing pre-operatively Alternative drug for history of anaphylactic reactions Colorectal Cefazolin* 2 g (3g for pts Ciprofloxacin 400 mg + weighing > 120kg) + metronidazole 500 mg metronidazole 500 mg OR Cefotetan 2 g OR Cefoxitin 1g High-risk gastro-duodenal and biliary Cefazolin 2 g (3g for pts weighing > 120kg) Breast Orthopedic (total joint replacement, closed fractures / use of nails, bone plates, other internal fixation devices, functional repair without implant /devices, trauma) Noncardiac thoracic thoracic (lobectomy, pneumonectomy, wedge resection, other noncardiac mediastinal procedures), closed tube thoracostomy Appendectomy (prophylaxis needed only in complicated or suppurative cases) Cefazolin 2 g (3g for pts weighing > 120kg) Cefazolin 2 g (3g for pts weighing > 120kg) Cefazolin 2 g (3g for pts weighing > 120kg) Cefazolin 2 g (3g for pts weighing > 120kg) + metronidazole 500 mg OR Cefotetan 2g OR Cefoxitin 2g Recommended re-dosing interval, hours Cefazolin, 4 Metronidazole, not needed, unless operation >8 hrs Cefotetan, 6 Cefoxitin, 2 Ciprofloxacin, not needed, unless operation >7 hrs Ciprofloxacin 400 mg Cefazolin, 4 Ciprofloxacin, not needed, unless operation >7 hrs Clindamycin 900 mg or Cefazolin, 4 Vancomycin 15 mg/kg Clindamycin, 6 Gentamicin 5 mg/kg + Clindamycin 900 mg Clindamycin 900mg Cefazolin, 4 Clindamycin, 6 Ciprofloxacin 400 mg + Metronidazole 500 mg Vancomycin, not needed, unless operation >8 hrs Cefazolin, 4 Gentamicin, not needed, unless operation >8 hrs Clindamycin 6 Cefazolin, 4 Metronidazole, not needed, unless operation >8 hrs Cefotetan, 6 Cefoxitin, 2 Ciprofloxacin, not needed, unless operation >7 hrs Obstetric and gynecologic Cefazolin 2 g (3g for pts weighing > 120kg) Ciprofloxacin 400 mg + Metronidazole 500mg Cefazolin, 4 Metronidazole, not needed, unless operation >8 hrs Ciprofloxacin, not needed, unless operation >7 hrs Urologic (may not be beneficial if urine is sterile) Cefazolin 2 g (3g for pts weighing > 120kg) Ciprofloxacin 400 mg + Metronidazole 500mg Cefazolin, 4 Metronidazole, not needed, unless operation >8 hrs Ciprofloxacin, not needed, unless operation >7 hrs Cardiac surgery Cefazolin 2 g (3g for pts Clindamycin 900mg Cefazolin, 4 Page 48

Procedure Antibiotic Prophylaxis Recommendation HEAD AND NECK (INTRACRANIAL) Craniotomy A Antibiotic prophylaxis is recommended Cerebrospinal Fluid (CSF) Shunt A Antibiotic prophylaxis is recommended Spinal surgery A Antibiotic prophylaxis is recommended HEAD AND NECK (OTHER) Head, facial or neck surgery (clean, benign) D Antibiotic prophylaxis is not recommended Head and neck surgery (clean, malignant; C Antibiotic prophylaxis should be considered neck dissection) Head and neck surgery (contaminated/cleancontaminated) A Antibiotic prophylaxis is recommended C D The duration of prophylactic antibiotics should not be more than 24 hours Ensured broad spectrum antimicrobial cover for aerobic and anaerobic organisms THORAX Breast cancer surgery A Antibiotic prophylaxis should be considered Open heart surgery C Antibiotic prophylaxis is recommended C The duration of prophylactic antibiotics should not Page be more 49 than 48 hours Pulmonary Resection A Antibiotic prophylaxis is recommended Etc

Initial SAP protocol Operation Group Antibiotics for PROPHYLAXIS Dose Timing General Surgery abdominal (eg laparotomy, appendisectomy (if no perforation), biliary tract surgery, colorectal surgery, gastroenteric surgery Ampicillin 2g Flagyl 500mg Single pre-op dose, no post-operative antibiotics General Surgery non-abdominal (eg hernia repair, mastectomy, thyroidectomy, plastic surgery, burns grafting, fasciotomy, cardiothoracic and vascular surgery, ) Ampicillin 2g Single pre-op dose, no post-operative antibiotics CLEAN Orthopaedic surgery (eg ORIF, craniotomy, interlocking nail) ANY Contaminated or Dirty/Infected operation Including Surgical Toilet, Abscess drainage, arthrotomy for septic arthritis, traumatic wound closure, any gastro-intestinal perforation, amputation for gangrene. Any patient with an infection at the time of surgery (eg chorioamnionitis, infected wound, abscess). Ceftriaxone 2g Ampicillin 2g Flagyl 500mg Single pre-op dose, no post-operative antibiotics Pre-operative PROPHYLAXIS AND then to received TREATMENT after operation as per clinicians prescription. Patient with reported allergy to penicillin, for any surgery *Note: there is a small risk of cross-allergy between Penicillins and Cephalosporins (approx 10% risk) Omit Ampicillin from AP if good history of allergy. Can use Ceftriaxone* (2g) instead if necessary. Single pre-op dose, no post-operative antibiotics

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Operation Group General Surgery abdominal (eg laparotomy, appendectomy (if no perforation), biliary tract surgery, colorectal surgery, gastroenteric surgery General Surgery non-abdominal (eg hernia repair, mastectomy, thyroidectomy, plastic surgery, burns grafting, fasciotomy Cardiothoracic and vascular surgery CLEAN Orthopaedic surgery (eg ORIF, craniotomy, interlocking nail) ANY Contaminated or Dirty/Infected operation Antibiotics for PROPHYLAXIS Cloxacillin 2 g + Gentamicin 5mg/kg + Metronidazole 500 mg Cloxacillin 2 g + Gentamicin 5mg/kg Second option Penicillin G dose 4 MU + Gentamicin 5mg/kg + Metronidazole 500 mg Dose Timing Single pre-op dose. No post-operative antibiotics, repeat Cloxacillin if > 4h intervention duration. Metronidazole and Gentamicin, no need to repeat, unless operation >8 h Single pre-op dose, no post-operative antibiotics, repeat Cloxacillin if > 4h intervention duration. Chloramphenicol 1 g Vancomycin 15 mg/kg Single pre-op dose, no post-operative antibiotics, repeat Chloramphenicol if > 4h and Vancomycin if >8h intervention duration. Gentamicin 5 mg/kg + Clindamycin 900 mg Cloxacillin 2 g X 6 times a day or 12 g in 500 cc continuous perfusion (over 24hrs) + Gentamicin 5mg/kg once daily for 5 days + Metronidazole 500 mg X times a day Vancomycin 15 mg/kg For severe cases - Imipenem 4x500mg Single pre-op dose, no post-operative antibiotics, repeat Clindamycin if > 6h and Vancomycin if >8h intervention duration. Single dose pre-operative PROPHYLAXIS and then TREATMENT after operation. Page 54

% of operations given prophylaxis Antibiotic prophylaxis Is it possible to get to 100% of patients getting - Right DRUG+DOSE - Right TIME - Right DURATION in an African Hospital? Thika Hospital, Kenya, 2010-2011, Aiken et al, PLOS ONE 2013 100% 80% 60% 40% AP Policy introduced Feb 2011 20% 0% % given PRE-op prophylaxis % given POST-op antibiotics

SSI : Overview of existing guidelines UK High impact intervention bundle (March 2011) USA Institute of Health Improvement Surgical Site Infection (Jan 2012) USA Institute of Health Improvement Hip & knee arthroplasty (Nov. 2012) Scottish Health Protection bundle (Oct 2013) Ireland : Royal College of Physicians (2012) SHEA (June 2014) CDC (Draft 2014) SKIN PREPARATION 2% Chlorhexidine gluconate (CHG) in 70 % isopropyl alcohol solution; povidone-iodine with alcohol for patients who are allergic to Chlorhexidine None Local preparation of 2% chlorhexidine isopropanol solution 1. Isopropanol: 62.7 % g/g Combination either an iodophor or CHG with alcohol is better than povidone-iodine alone 2% CHG in 70 % isopropyl alcohol solution; povidone-iodine with alcohol for patients who are allergic to CHG 1A 2% CHG in 70 % isopropyl alcohol solution; povidone-iodine with alcohol for patients who are allergic to CHG 35ml Povidone-iodine or chlorhexidine, though alcohol-based solutions may 200ml be more effective than aqueous solutions. Most effective antiseptic for skin preparation before surgical incision remains Up uncertain to 1 liter I Wash and clean skin around incision site. Use a dual agent skin preparation containing alcohol, unless contraindications exist 1A Perform intraoperative skin preparation with an appropriate antiseptic agent. Use an antiseptic agent with alcohol, unless contraindicated. 2. Chlorhexidin digluconate 18.8% g/g solution: 12.1 % g/g 3. Distilled water up to 100% Chlohexidine gluconate 2% w/v NICE Distilled / cool boiled water (June 2013) Ethanol 95%

Surgical hand and skin preparation Intervention steps 2. Surgical hand preparation Antimicrobial soap+water = 2 5 mins Alcohol-based = 1.5 3 mins Good technique is crucial! Nail-brushes not recommended Page 57

Surgical handrubbing technique

WHO MODIFIED FORMULATIONS Formulation I Final concentrations: Ethanol 80 % w/w, glycerol 0.725 % v/v, hydrogen peroxide 0.125 % v/v. Ingredients: 1. Ethanol (absolute), 800 g 2. H 2 O 2 (3%), 4.17 ml 3. Glycerol (98%), 7.25 ml (or 7.25 x 1.26 = 9.135 g) 4. Top up to 1000 g with distilled or boiled water Formulation II Final concentrations:isopropanol 75 % w/w, glycerol 0.725 % v/v, hydrogen peroxide 0.125 % v/v. Ingredients: 1. Isopropanol (absolute), 750 g 2. H 2 O 2 (30%), 4.17 ml 3. Glycerol (98%), 7.25 ml (or 7.25 x 1.26 = 9.135 g) 4. Top up to 1000 g with distilled water Page 59

Handwashing quality score 100 90 80 70 60 50 40 30 20 10 0 1 2 3 4 5 6 7 8 9 high low med

Inappropriate reprocessing of medical devices and surgical instruments Washed under running water Immersed in 2% glutaraldehyde for 8-10 hrs

Expert group on safe reprocessing of medical devices and sterilization Mehtar Shaheen South Africa Christina Bradley UK Dianne Trudeau Canada Lisa Huber USA Nizam Damani UK/Pakistan Oonagh Ryan UK 62

Thank you for your attention For more information: Contact information WHO SERVICE DELIVERY AND SAFETY patient.safety@who.int savelives@who.int Web sites http://www.who.int/patien tsafety/en/ www.who.int/gpsc/5may

2015 Save the Date: 3 rd ICPIC, 16-19 June 2015, Geneva, Switzerland Semmelweis at ICPIC www.icpic2013.com