- Email: [email protected]
World Health Organization: global guidelines for the prevention of surgical site infection
Accepted Manuscript WHO: global guidelines for the prevention of surgical site infection David J. Leaper, Emeritus Professor of Surgery, Charles E. Edmiston, Emeritus Professor of Surgery PII:
S0195-6701(16)30587-4
DOI:
10.1016/j.jhin.2016.12.016
Reference:
YJHIN 4993
To appear in:
Journal of Hospital Infection
Received Date: 19 December 2016 Accepted Date: 19 December 2016
Please cite this article as: Leaper DJ, Edmiston CE, WHO: global guidelines for the prevention of surgical site infection, Journal of Hospital Infection (2017), doi: 10.1016/j.jhin.2016.12.016. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT
WHO: global guidelines for the prevention of surgical site infection
RI PT
David J. Leaper, Emeritus Professor of Surgery, University of Newcastle upon Tyne, UK
Correspondence:
M AN U
SC
Charles E. Edmiston, Emeritus Professor of Surgery, Medical College of Wisconsin, Milwaukee, Wisconsin, USA
[email protected]
AC C
EP
TE D
Key words: surgical site infection, WHO, CDC, NICE, guidelines, care bundles, definitions, compliance, post-discharge surveillance
ACCEPTED MANUSCRIPT Developing countries will welcome this important guideline from the World Health Organisation (WHO).1 It bears similar presentation and content as the guidelines for the prevention of surgical site infection (SSI) published by the National Institute for Health and Care Excellence (NICE),2 in particular the timing of interventions in pre-, intra- and postoperative periods, and the Centers for Disease Control (CDC) using similar criteria and
RI PT
methods.3 There are no recommendations on the treatment of SSI but the WHO guideline is a comprehensive review of preventative measures and appears to be aimed at wide and general audience. It is hoped that this worldwide group of practitioners will fully comprehend the complexities and need for systematic review and meta-analysis, PRISMA, PICO, GRADE
SC
and evidence-based medicine. However, the recommendations are presented appropriately and an easily understood table in the WHO guideline and the use of “expert opinion”
M AN U
correctly avoided wherever possible.
The WHO technical consultations resulted in 29 recommendations being given: so what’s in common with currently published equivalent guidelines and what isn’t? The WHO guideline development group qualified each recommendation by considering the best evidence available using systematic reviews and meta-analysis where appropriate, and avoidance of risk of bias using GRADE assessment tables. The quality of evidence presented is graded
TE D
from “very low” to “high” on a four point scale with justification derived from appropriate articles acquired from a wide systematic search and review. Recommendations to support antibiotic prophylaxis, hair removal and maintenance of
EP
normothermia are similar to the NICE and the CDC guidelines.2,3 Recommendations for maintenance of blood glucose and methods of skin preparation (although preparation with alcoholic antiseptics is widely accepted as being optimal) are also similar but are supported
AC C
with less enthusiasm. Oral antibiotics are recommended in colorectal surgery together with mechanical bowel preparation (in common with CDC guidelines but not NICE) but MBP alone is not recommended to reduce SSI,3 the risk of not undertaking MBP prior to left-sided colectomy is not addressed. There are views presented that skin sealants and specific wound dressings are unsupportable for recommendation based on the evidence they found; again common to NICE and CDC.2,3 Several recommendations for SSI prevention are less strongly supported and clearly need more RCT evidence to support them. Preoperative bathing with 4% liquid or 2% coated cloth formulations of chlorhexidine gluconate (CHG) is not strongly endorsed, mostly related to
ACCEPTED MANUSCRIPT poorly designed and executed clinical studies. However, recent clinical evidence has shown that a standardized regimen using both 4% liquid and 2% coated cloth formulations results in high, sustainable (and reproducible) skin surface concentrations of CHG.4,5 Additional interventions that need further documentation include the role of Staphylococcus aureus decolonization, for example with mupirocin nasal ointment (such treatment needs to be
RI PT
selective and is only temporarily suppressive at best; no mention of the concern around selection of mupirocin resistance is made); hand preparation/scrubbing with soap alone is considered adequate (NICE found no indication for the traditional “scrub”);2 similar common sense advice is directed at the use of gowns, drapes and gloves, wound protectors, changing
SC
instruments, incisional wound irrigation and use of drains (in common with other guidelines); as is the need for nutritional support and ensuring physiological homeostasis.
M AN U
It is disappointing that a more positive recommendation is not offered for the use of antimicrobial sutures, when several supportive systematic reviews and meta-analyses and convincing economic health care benefits have been published;6 these are not referred to in the guideline.1 Likewise, there is no reference to the positive results being found for the use of incisional negative pressure therapy in wounds at risk of infection and dehiscence.7 Little is said about the difficulties with definitions of SSI in this new document; many
TE D
different definitions have been published which makes comparison of trials difficult.8 The CDC definition is the most widely used but it lacks an indication of severity of SSI which can vary between being life threatening, for example sternal dehiscence after open cardiac
EP
surgery, or socially inconvenient, such as the discharge of a bead of pus 10 days after herniorrhaphy. The whole surgical team needs to understand this: it could be argued that the most severe deep/organ space SSIs (with the highest attendant morbidity and mortality)
AC C
reflect a failure of surgical technique, such as an anastomotic leak leading to an intraperitoneal abscess, rather than the failure of guideline recommendations. There is a wide difference between superficial and deep SSIs, which are probably preventable, and deep/organ space infections which are probably not. Solving this conundrum needs the appointment of dedicated, trained and validated observers who are able to undertake close post-discharge surveillance to ensure accuracy and completeness of data. Infection prevention and control professionals, who can do this, are considered by many to be an expensive luxury; in this editorial the authors’ opinion is that they are not. SSIs are becoming the most common health care associated infections (HCAIs) despite widespread introduction of
ACCEPTED MANUSCRIPT guidelines in the UK, Europe and North America but the incidence of SSIs is not declining. This has to reflect the accuracy of post discharge surveillance. Sadly, there appears to be little advice on the use of care bundles which have been shown to reduce the risk of SSIs.9 Equally important is the need for compliance with, for example, an agreed 6-7 point bundle all of which have a scientific evidence base to support their use
RI PT
(preoperative showering, appropriate hair removal and skin preparation, rational antibiotic prophylaxis, antimicrobial sutures, maintenance of perioperative normothermia and blood glucose control). To mandate adherence to care bundles is a subject which first requires
References
M AN U
low superficial and deep SSIs after surgical procedures.10
SC
prospective research to prove that high compliance with agreed care bundles results in very
1. Global guidelines for the prevention of surgical site infection. World Health Organisation 2016.
TE D
2. National Institute for Health and Care Excellence. Surgical site infection: prevention and treatment of surgical site infection.
Clinical guideline 74. London: National Institute for Health and Clinical Excellence; 2008.
EP
Evidence update 43. London: National Institute for Health and Clinical Excellence; 2013. 3. Department of Health and Human Services. Centers for Disease Control and Prevention.
AC C
National center for emerging and zoonotic infectious diseases. Division of Healthcare Quality Promotion Healthcare Infection Control Practices Advisory Committee (HICPAC) meeting summary report, April 10-11, 2014. The Centers for Disease Control and Prevention, Atlanta, Georgia https://www.cdc.gov/hicpac/.../HICPAC_April2014_Summary_With_Liaison_Reports. Accessed 5 December 2016 4. Edmiston CE, Krepel C, Spencer M, et al. Evidence for preadmission showering regimen to achieve maximal antiseptic skin surface concentrations of chlorhexidine gluconate 4% in surgical patients. JAMA Surg 2015;150:1027-1032.
ACCEPTED MANUSCRIPT 5. Edmiston CE, Krepel CJ, Spencer, M, et al. Preadmission application of 2% chlorhexidine gluconate (CHG): enhancing patient compliance while maximizing skin surface concentrations. Infect Control Hosp Epidemiol 2016;37:254-259. 6. Leaper DJ, Edmiston CE, Holy CE. Managing healthcare resources: estimated budget impact on the National Health Service (England) of introduction of antimicrobial sutures
RI PT
Br J Surg 2016: In press
7. Krug E, Berg L, Lee C, et al. Evidence-based recommendations for the use of negative pressure wound therapy in traumatic wounds and reconstructive surgery.
SC
Injury 2011;42 (Suppl 1):S1–S12
8. Leaper D, Tanner J, Kiernan M. Surveillance of surgical site infection: more accurate
M AN U
definitions and intensive recording needed. J Hosp Infect 2013;83:83-86.
9. Tanner J, Padley W, Assadian O, Leaper D, Kiernan M, Edmiston C. Do surgical care bundles reduce the risk of surgical site infections in patients undergoing colorectal surgery? A systematic review and cohort meta-analysis of 8,515 patients. Surgery 2015;158:66-77. 10. Leaper DJ, Tanner J, Kiernan M, Assadian O, Edmiston CE Jr. Surgical site infection:
AC C
EP
TE D
poor compliance with guidelines and care bundles. Int Wound J 2015;12:357-362.
S0195-6701(16)30587-4
DOI:
10.1016/j.jhin.2016.12.016
Reference:
YJHIN 4993
To appear in:
Journal of Hospital Infection
Received Date: 19 December 2016 Accepted Date: 19 December 2016
Please cite this article as: Leaper DJ, Edmiston CE, WHO: global guidelines for the prevention of surgical site infection, Journal of Hospital Infection (2017), doi: 10.1016/j.jhin.2016.12.016. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT
WHO: global guidelines for the prevention of surgical site infection
RI PT
David J. Leaper, Emeritus Professor of Surgery, University of Newcastle upon Tyne, UK
Correspondence:
M AN U
SC
Charles E. Edmiston, Emeritus Professor of Surgery, Medical College of Wisconsin, Milwaukee, Wisconsin, USA
[email protected]
AC C
EP
TE D
Key words: surgical site infection, WHO, CDC, NICE, guidelines, care bundles, definitions, compliance, post-discharge surveillance
ACCEPTED MANUSCRIPT Developing countries will welcome this important guideline from the World Health Organisation (WHO).1 It bears similar presentation and content as the guidelines for the prevention of surgical site infection (SSI) published by the National Institute for Health and Care Excellence (NICE),2 in particular the timing of interventions in pre-, intra- and postoperative periods, and the Centers for Disease Control (CDC) using similar criteria and
RI PT
methods.3 There are no recommendations on the treatment of SSI but the WHO guideline is a comprehensive review of preventative measures and appears to be aimed at wide and general audience. It is hoped that this worldwide group of practitioners will fully comprehend the complexities and need for systematic review and meta-analysis, PRISMA, PICO, GRADE
SC
and evidence-based medicine. However, the recommendations are presented appropriately and an easily understood table in the WHO guideline and the use of “expert opinion”
M AN U
correctly avoided wherever possible.
The WHO technical consultations resulted in 29 recommendations being given: so what’s in common with currently published equivalent guidelines and what isn’t? The WHO guideline development group qualified each recommendation by considering the best evidence available using systematic reviews and meta-analysis where appropriate, and avoidance of risk of bias using GRADE assessment tables. The quality of evidence presented is graded
TE D
from “very low” to “high” on a four point scale with justification derived from appropriate articles acquired from a wide systematic search and review. Recommendations to support antibiotic prophylaxis, hair removal and maintenance of
EP
normothermia are similar to the NICE and the CDC guidelines.2,3 Recommendations for maintenance of blood glucose and methods of skin preparation (although preparation with alcoholic antiseptics is widely accepted as being optimal) are also similar but are supported
AC C
with less enthusiasm. Oral antibiotics are recommended in colorectal surgery together with mechanical bowel preparation (in common with CDC guidelines but not NICE) but MBP alone is not recommended to reduce SSI,3 the risk of not undertaking MBP prior to left-sided colectomy is not addressed. There are views presented that skin sealants and specific wound dressings are unsupportable for recommendation based on the evidence they found; again common to NICE and CDC.2,3 Several recommendations for SSI prevention are less strongly supported and clearly need more RCT evidence to support them. Preoperative bathing with 4% liquid or 2% coated cloth formulations of chlorhexidine gluconate (CHG) is not strongly endorsed, mostly related to
ACCEPTED MANUSCRIPT poorly designed and executed clinical studies. However, recent clinical evidence has shown that a standardized regimen using both 4% liquid and 2% coated cloth formulations results in high, sustainable (and reproducible) skin surface concentrations of CHG.4,5 Additional interventions that need further documentation include the role of Staphylococcus aureus decolonization, for example with mupirocin nasal ointment (such treatment needs to be
RI PT
selective and is only temporarily suppressive at best; no mention of the concern around selection of mupirocin resistance is made); hand preparation/scrubbing with soap alone is considered adequate (NICE found no indication for the traditional “scrub”);2 similar common sense advice is directed at the use of gowns, drapes and gloves, wound protectors, changing
SC
instruments, incisional wound irrigation and use of drains (in common with other guidelines); as is the need for nutritional support and ensuring physiological homeostasis.
M AN U
It is disappointing that a more positive recommendation is not offered for the use of antimicrobial sutures, when several supportive systematic reviews and meta-analyses and convincing economic health care benefits have been published;6 these are not referred to in the guideline.1 Likewise, there is no reference to the positive results being found for the use of incisional negative pressure therapy in wounds at risk of infection and dehiscence.7 Little is said about the difficulties with definitions of SSI in this new document; many
TE D
different definitions have been published which makes comparison of trials difficult.8 The CDC definition is the most widely used but it lacks an indication of severity of SSI which can vary between being life threatening, for example sternal dehiscence after open cardiac
EP
surgery, or socially inconvenient, such as the discharge of a bead of pus 10 days after herniorrhaphy. The whole surgical team needs to understand this: it could be argued that the most severe deep/organ space SSIs (with the highest attendant morbidity and mortality)
AC C
reflect a failure of surgical technique, such as an anastomotic leak leading to an intraperitoneal abscess, rather than the failure of guideline recommendations. There is a wide difference between superficial and deep SSIs, which are probably preventable, and deep/organ space infections which are probably not. Solving this conundrum needs the appointment of dedicated, trained and validated observers who are able to undertake close post-discharge surveillance to ensure accuracy and completeness of data. Infection prevention and control professionals, who can do this, are considered by many to be an expensive luxury; in this editorial the authors’ opinion is that they are not. SSIs are becoming the most common health care associated infections (HCAIs) despite widespread introduction of
ACCEPTED MANUSCRIPT guidelines in the UK, Europe and North America but the incidence of SSIs is not declining. This has to reflect the accuracy of post discharge surveillance. Sadly, there appears to be little advice on the use of care bundles which have been shown to reduce the risk of SSIs.9 Equally important is the need for compliance with, for example, an agreed 6-7 point bundle all of which have a scientific evidence base to support their use
RI PT
(preoperative showering, appropriate hair removal and skin preparation, rational antibiotic prophylaxis, antimicrobial sutures, maintenance of perioperative normothermia and blood glucose control). To mandate adherence to care bundles is a subject which first requires
References
M AN U
low superficial and deep SSIs after surgical procedures.10
SC
prospective research to prove that high compliance with agreed care bundles results in very
1. Global guidelines for the prevention of surgical site infection. World Health Organisation 2016.
TE D
2. National Institute for Health and Care Excellence. Surgical site infection: prevention and treatment of surgical site infection.
Clinical guideline 74. London: National Institute for Health and Clinical Excellence; 2008.
EP
Evidence update 43. London: National Institute for Health and Clinical Excellence; 2013. 3. Department of Health and Human Services. Centers for Disease Control and Prevention.
AC C
National center for emerging and zoonotic infectious diseases. Division of Healthcare Quality Promotion Healthcare Infection Control Practices Advisory Committee (HICPAC) meeting summary report, April 10-11, 2014. The Centers for Disease Control and Prevention, Atlanta, Georgia https://www.cdc.gov/hicpac/.../HICPAC_April2014_Summary_With_Liaison_Reports. Accessed 5 December 2016 4. Edmiston CE, Krepel C, Spencer M, et al. Evidence for preadmission showering regimen to achieve maximal antiseptic skin surface concentrations of chlorhexidine gluconate 4% in surgical patients. JAMA Surg 2015;150:1027-1032.
ACCEPTED MANUSCRIPT 5. Edmiston CE, Krepel CJ, Spencer, M, et al. Preadmission application of 2% chlorhexidine gluconate (CHG): enhancing patient compliance while maximizing skin surface concentrations. Infect Control Hosp Epidemiol 2016;37:254-259. 6. Leaper DJ, Edmiston CE, Holy CE. Managing healthcare resources: estimated budget impact on the National Health Service (England) of introduction of antimicrobial sutures
RI PT
Br J Surg 2016: In press
7. Krug E, Berg L, Lee C, et al. Evidence-based recommendations for the use of negative pressure wound therapy in traumatic wounds and reconstructive surgery.
SC
Injury 2011;42 (Suppl 1):S1–S12
8. Leaper D, Tanner J, Kiernan M. Surveillance of surgical site infection: more accurate
M AN U
definitions and intensive recording needed. J Hosp Infect 2013;83:83-86.
9. Tanner J, Padley W, Assadian O, Leaper D, Kiernan M, Edmiston C. Do surgical care bundles reduce the risk of surgical site infections in patients undergoing colorectal surgery? A systematic review and cohort meta-analysis of 8,515 patients. Surgery 2015;158:66-77. 10. Leaper DJ, Tanner J, Kiernan M, Assadian O, Edmiston CE Jr. Surgical site infection:
AC C
EP
TE D
poor compliance with guidelines and care bundles. Int Wound J 2015;12:357-362.