Essential best practices for the prevention of surgical

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

Munday GS, et al. The American Journal of Surgery, 2014

http://dx.doi.org/10.1016/j.amjsurg.2014.05.005

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

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.

London, UK

EURO EMRO

WPRO I

SEARO

AFRO

PAHO I

Amman, JordanToronto, Canada

New Delhi, India

Manila, Philippines

Ifakara, Tanzania

WPRO II

Auckland, NZ

PAHO II

Seattle, USA

The Checklist was piloted in 8 cities…

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

+

Patient safety climate improvement (CUSP):

• Science of safety education

• Staff safety assessment

• Leadership

• Learning from defects

• Team work & communications

Infection prevention & control

Best practices

Safe Surgery Checklist

Improvement of the patient

safety climate

+

Surgical Unit-based Safety Programme (SUSP)

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

WHAT WE DO

Adaptive

• Behaviours

• Attitudes

• Values

• Beliefs

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

1. Patient pre-operative bathing

Challenges Interventions

Cost Sourced for fair priced soap

Patient acceptability to change soap Did a survey for tolerability to new soap.

Well received by patients

Bathing times not linked to time of

surgery.

SOP created and nurses educated

Nurses fetching hot water for bedside

bathing

Instant showers to lessen work

Example 1 of Kijabe approach to “technical” elements of

SUSP intervention – identifying problems +solutions

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

operationPage 43

6. Discipline in the OR - limiting number of people and door opening during operationsChallenges

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

Example 2 of Kijabe approach to “technical” elements of

SUSP intervention – identifying problems +solutions

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.

Page 48

Procedure Drug/dosing pre-operatively Alternative drug for history of

anaphylactic reactions

Recommended re-dosing interval, hours

Colorectal Cefazolin* 2 g (3g for pts

weighing > 120kg) +

metronidazole 500 mg OR

Cefotetan 2 g OR

Cefoxitin 1g

Ciprofloxacin 400 mg +

metronidazole 500 mg

Cefazolin, 4

Metronidazole, not needed, unless operation >8 hrs

Cefotetan, 6

Cefoxitin, 2

Ciprofloxacin, not needed, unless operation >7 hrs

High-risk gastro-duodenal and biliary Cefazolin 2 g (3g for pts

weighing > 120kg)

Ciprofloxacin 400 mg Cefazolin, 4


Breast Cefazolin 2 g (3g for pts

weighing > 120kg)

Clindamycin 900 mg or

Vancomycin 15 mg/kg

Cefazolin, 4

Clindamycin, 6

Vancomycin, not needed, unless operation >8 hrs

Orthopedic – (total joint replacement,

closed fractures / use of nails, bone

plates, other internal fixation devices,

functional repair without implant

/devices, trauma)

Cefazolin 2 g (3g for pts

weighing > 120kg)

Gentamicin 5 mg/kg +

Clindamycin 900 mg

Cefazolin, 4

Gentamicin, not needed, unless operation >8 hrs

Clindamycin 6

Noncardiac thoracic – thoracic

(lobectomy, pneumonectomy, wedge

resection, other noncardiac

mediastinal procedures), closed tube

thoracostomy


weighing > 120kg)

Clindamycin 900mg Cefazolin, 4

Clindamycin, 6

Appendectomy

(prophylaxis needed only in

complicated or suppurative cases)


weighing > 120kg) +

metronidazole 500 mg OR

Cefotetan 2g OR

Cefoxitin 2g


Metronidazole 500 mg

Cefazolin, 4


Cefotetan, 6

Cefoxitin, 2


Obstetric and gynecologic Cefazolin 2 g (3g for pts

weighing > 120kg)


Metronidazole 500mg

Cefazolin, 4



Urologic (may not be beneficial if urine

is sterile)


weighing > 120kg)


Metronidazole 500mg

Cefazolin, 4



Cardiac surgery Cefazolin 2 g (3g for pts

weighing > 120kg)

Clindamycin 900mg Cefazolin, 4

Clindamycin, 6

Page 49

Procedure Antibiotic Prophylaxis RecommendationHEAD 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;

neck dissection)

C Antibiotic prophylaxis should be considered

Head and neck surgery (contaminated/clean-

contaminated)

A Antibiotic prophylaxis is recommended

The duration of prophylactic antibiotics should not be more

than 24 hours

Ensured broad spectrum antimicrobial cover for aerobic

and anaerobic organisms

C

D

THORAX

Breast cancer surgery A Antibiotic prophylaxis should be considered

Open heart surgery C Antibiotic prophylaxis is recommended

The duration of prophylactic antibiotics should not be more

than 48 hours

C

Pulmonary Resection A Antibiotic prophylaxis is recommended

Etc…

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,


CLEAN Orthopaedic surgery

(eg ORIF, craniotomy, interlocking nail)

Ceftriaxone 2g Single pre-op dose,


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).

Ampicillin 2g

Flagyl 500mg

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,


Initial SAP protocol

Page 52

Operation Group Antibiotics for PROPHYLAXIS Dose Timing


(eg laparotomy, appendisectomy (if no perforation), biliary tract

surgery, colorectal surgery, gastroenteric surgery

Ampicillin 2g

Flagyl 500mg

Single pre-op dose,



(eg hernia repair, mastectomy, thyroidectomy, plastic surgery, burns

grafting , fasciotomy, cardiothoracic and vascular surgery, )

Ampicillin 2g Single pre-op dose,



(eg ORIF, craniotomy, interlocking nail)

Ceftriaxone 2g Single pre-op dose,


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).

Ampicillin 2g

Flagyl 500mg

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,


Initial SAP protocol

Page 54

Operation Group Antibiotics for

PROPHYLAXIS

Second option Dose Timing


(eg laparotomy, appendectomy (if

no perforation), biliary tract

surgery, colorectal surgery,

gastroenteric surgery

Cloxacillin 2 g

+

Gentamicin 5mg/kg

+


Penicillin G dose 4 MU

+ Gentamicin 5mg/kg +


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


(eg hernia repair, mastectomy,

thyroidectomy, plastic surgery,

burns grafting , fasciotomy

Cloxacillin 2 g

+ Gentamicin 5mg/kg

Single pre-op dose,

no post-operative antibiotics,

repeat Cloxacillin if > 4h intervention

duration.

Cardiothoracic and vascular

surgery

Chloramphenicol 1 g Vancomycin 15 mg/kg Single pre-op dose,


repeat Chloramphenicol if > 4h and

Vancomycin if >8h intervention duration.


(eg ORIF, craniotomy, interlocking

nail)

Gentamicin 5 mg/kg +

Clindamycin 900 mg

Vancomycin 15 mg/kg Single pre-op dose,


repeat Clindamycin if > 6h and

Vancomycin if >8h intervention duration.

ANY Contaminated or

Dirty/Infected operation

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

For severe cases -

Imipenem 4x500mg

Single dose pre-operative

PROPHYLAXIS and then TREATMENT

after operation.

Antibiotic prophylaxisIs it possible to get to 100% of patients getting

- Right DRUG+DOSE

- Right TIME

- Right DURATION

in an African Hospital ?

0%

20%

40%

60%

80%

100%

% o

f opera

tions g

iven p

rophyla

xis

% given PRE-op prophylaxis

% given POST-op antibiotics

AP Policy

introduced

Feb 2011

Thika Hospital, Kenya, 2010-2011, Aiken et al, PLOS ONE 2013

SSI : Overview of existing guidelines

SKIN PREPARATIONUK High impact intervention bundle

(March 2011)

2% Chlorhexidine gluconate (CHG) in 70 % isopropyl alcohol solution;

povidone-iodine with alcohol for patients who are allergic to

Chlorhexidine

USA Institute of Health Improvement

Surgical Site Infection (Jan 2012)

None

USA Institute of Health Improvement

Hip & knee arthroplasty (Nov. 2012)

Combination either an iodophor or CHG with alcohol is better than

povidone-iodine alone

Scottish Health Protection bundle

(Oct 2013)

2% CHG in 70 % isopropyl alcohol

solution; povidone-iodine with alcohol for patients who are allergic to

CHG

Ireland : Royal College of

Physicians (2012)

1A

2% CHG in 70 % isopropyl alcohol solution; povidone-iodine with alcohol

for patients who are allergic to CHG

NICE

(June 2013)

Povidone-iodine or chlorhexidine, though alcohol-based solutions may

be more effective than aqueous solutions. Most effective antiseptic for

skin preparation before surgical incision remains uncertain

SHEA

(June 2014)

I

Wash and clean skin around incision site. Use a dual agent skin

preparation containing alcohol, unless contraindications exist

CDC (Draft 2014) 1A

Perform intraoperative skin preparation with an appropriate antiseptic

agent. Use an antiseptic agent with alcohol, unless contraindicated.

Local preparation of 2% chlorhexidine isopropanol solution

1. Isopropanol: 62.7 % g/g

2. Chlorhexidin digluconate 18.8% g/g solution: 12.1 % g/g

3. Distilled water up to 100%

Chlohexidine gluconate 2% w/v 35ml

Distilled / cool boiled water 200ml

Ethanol 95% Up to 1 liter

Surgical hand and skin preparation

Page 57

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

Surgical handrubbingtechnique

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. H2O2 (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. H2O2 (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

0

10

20

30

40

50

60

70

80

90

100

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

62

Mehtar Shaheen South Africa

Christina Bradley UK

Dianne Trudeau Canada

Lisa Huber USA

Nizam Damani UK/Pakistan

Oonagh Ryan UK

Thank you for your attention

For more information:

• Contact information

WHO SERVICE

DELIVERY AND SAFETY

[email protected]

[email protected]

• Web sites

http://www.who.int/patien

tsafety/en/

www.who.int/gpsc/5may

mailto:[email protected]

mailto:[email protected]

http://www.who.int/patientsafety

http://www.who.int/gpsc/5may

Semmelweis at ICPIC

www.icpic2013.com

2015Save the Date:

3rd ICPIC, 16-19 June 2015,

Geneva, Switzerland

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Essential best practices for the prevention of surgical