NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE Centre for Clinical Practice Recommendation for Guidance Executive Review of Clinical Guideline (CG74) - Prevention and treatment of surgical site infection

Background information Guideline issue date: 2008 3 year review: 2011 National Collaborating Centre: Women’s and Children’s Health

Review recommendation 

The guideline should not be updated at this time.

Factors influencing the decision Literature search 1. From a high-level randomised control trial (RCT) search, new evidence was identified relating to the following clinical areas within the guideline: 

Preoperative phase (preoperative showering; hair removal; staff theatre wear; nasal decontamination; mechanical bowel preparation and antibiotic prophylaxis)



Intraoperative phase (hand decontamination; antiseptic skin preparation; maintaining patient homeostasis; wound irrigation;

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antiseptic agents before wound closure; closure methods and wound dressings) 

Postoperative phase (postoperative cleansing; topical antimicrobial agents; dressings for wound healing and debridement)

2. Through this stage of the process, a sufficient number of studies relevant to the following clinical areas were identified to allow assessment for proposed review decision. No conclusive new evidence was identified in these areas which would change the direction of current guideline recommendations.

3. From initial intelligence gathering, qualitative feedback from other NICE departments, the views expressed by the Guideline Development Group, as well as the high-level RCT search, additional focused searches were also conducted for the following clinical areas: 

Intraoperative phase: antiseptic skin preparation



Intraoperative phase: maintaining patient homeostasis (perioperative blood glucose control)



Intraoperative phase: closure methods



Postoperative phase: dressings for wound healing by secondary intention

4. No new evidence was identified which would contradict the current guideline recommendations apart from evidence relating to antiseptic skin preparation. 5. The new evidence on antiseptic skin preparation indicated a beneficial effect of chlorhexidine over povidone-iodine on surgical site infection rates. However, this was considered insufficient evidence to warrant an update of the guideline at this time.

6. Several ongoing clinical trials (publication dates unknown) were identified focusing on provision of information for patients and carers CG74 Surgical Site Infection Review Proposal for GE 020811

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prior to a surgical procedure, antibiotic prophylaxis and closure methods. Guideline Development Group and National Collaborating Centre perspective 7. A questionnaire was distributed to GDG members and the National Collaborating Centre (NCC) to consult them on the need for an update of the guideline. Four responses were received with respondents highlighting that since publication of the guideline more literature has become available on chlorhexidine skin preparation (in particular, new studies are in development comparing povidone-iodine-alcohol with chlorhexidine-alcohol), antiseptic dressings, antibiotic prophylaxis and blood glucose control during surgery.

8. Ongoing research relevant to the guideline was highlighted by GDG members including the use of wound dressings impregnated with polyhexamethylene biguanide. 9. This feedback contributed towards the development of the clinical questions for the focused searches. Implementation and post publication feedback 10. In total 71 enquiries were received from post-publication feedback, most of which were routine. Key themes emerging from postpublication feedback were the use of silver and honey dressings for post-operative wounds and the development of microbial sealants to prevent intraoperative contamination of surgical incisions. This feedback contributed towards the development of the clinical questions described above.

11. An analysis by the NICE implementation team highlighted key issues identified at the time of guideline publication: 

The availability of tissue viability nurses/specialist wound care nurses could be a barrier to implementation

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

Pooling of best practice into ‘care bundles’, which should reduce the risk of surgical site infection, needs to be piloted which could delay implementation of the recommendations

12. NICE provided implementation support to address the above issues.

Relationship to other NICE guidance 13. NICE guidance related to CG74 can be viewed in Appendix 1. Summary of Stakeholder Feedback Review proposal put to consultees: The guideline should not be updated at this time. The guideline will be reviewed again according to current processes.

14. In total 14 stakeholders commented on the review proposal recommendation during the 2 week consultation period.

15. The majority of stakeholders disagreed with the review proposal recommendation that this guideline should not be updated at this time.

16. Those stakeholders that disagreed with the review proposal commented that: 

They agreed with the assessment of the new evidence identified in the consultation document which demonstrated a beneficial effect of chlorhexidine over povidone-iodine for antiseptic skin preparation but that they felt this is enough evidence to warrant an update of the guideline at this time. However, the current guideline recommendation states that skin at the surgical site should be prepared immediately before incision using an antiseptic (aqueous or alcohol-based) preparation: povidone-iodine or chlorhexidine are most suitable. As such, this recommendation does not provide

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indication of a first-line antiseptic. However, based on the quality of studies identified through this review process (in particular, RCTs comparing different comparators and preparations of antiseptics), there is insufficient evidence at this time to conclude which antiseptic is better. New ongoing trials comparing povidone-iodinealcohol with chlorhexidine-alcohol will inform a future review of the guideline. This clinical area will be monitored and assessed again at the next review.

17. The table of stakeholder comments can be viewed in Appendix 2. Anti-discrimination and equalities considerations 18. No evidence was identified to indicate that the guideline scope does not comply with anti-discrimination and equalities legislation. The original scope contains recommendations for all patients, both adults and children, undergoing surgical incisions through the skin (including minimally invasive surgery such as arthroscopic, thoracoscopic and laparoscopic surgery).

Conclusion 19. From the evidence and intelligence identified through the process, new evidence was identified on antiseptic skin preparation indicating a beneficial effect of chlorhexidine over povidone-iodine on surgical site infection rates. Overall, this is not sufficient evidence to warrant an update of the guideline at this time but it will be taken into consideration in the next update review.

Relationship to quality standards 20. This topic is not currently being considered for inclusion in the scope of a quality standard.

21. This topic is currently being considered as one of the proposed core library topics. CG74 Surgical Site Infection Review Proposal for GE 020811

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Fergus Macbeth – Centre Director Sarah Willett – Associate Director Emma McFarlane – Technical Analyst Centre for Clinical Practice 2 August 2011

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Appendix 1 The following NICE guidance is related to CG74:

Guidance

Review date

TA24: Guidance on the use of debriding

This guidance was replaced by

agents and specialist wound care clinics

CG74 surgical site infection.

for difficult to heal surgical wounds, 2001. CG50: Recognition of and response to

To be reviewed: July 2013.

acute illness in adults in hospital, 2007. CG65: Inadvertent perioperative

Currently being considered for an

hypothermia, 2008.

update.

Review decision date September 2011. Related NICE guidance in progress Clinical guideline: Infection control,

Currently in progress.

prevention of healthcare-associated infection in primary and community care (update of CG2).

Expected publication date March 2012.

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Appendix 2 NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE Surgical Site Infection Guideline Review Consultation Comments Table 13 - 26 June 2011

Stakeholder

Agree with

organisation

Comments

Comments on

Comments on

proposal not to

areas excluded

equality issues

update?

from original

Responses

scope ARHAI

Update

ARHAI feels that the reliance on Cochrane reviews is not helpful. Randomised control trials are not the only source of scientific evidence. Guidelines must include best evidence available and not rely on metaanalyses alone. There are good comparative trials relating to SSI

ARHAI

Update

ARHAI would like to see greater emphasis on the need to maximise compliance to this guideline

ARHAI

Update

ARHAI felt that not including ‘Preventing Surgical-Site Infections in Nasal Carriers of Staphylococcus aureus - Bode et al. N

CG74 Surgical Site Infection Review Proposal for GE 020811

Thank you for your comment. The review of the guideline identified evidence of the same study types (for example, RCTs) as those used for the original guideline. Thank you for your comment. Implementation support is provided by NICE to facilitate implementation of the guideline. Thank you for providing this reference.

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Engl J Med 2010; 362:9-17’ in the literature review was a major omission.

This clinical area will be monitored and assessed again at the next review.

This study concluded that the number of surgical-site S. aureus infections acquired in the hospital can be reduced by rapid screening and decolonizing of nasal carriers of S. aureus on admission The advice on hair removal reaches level 1evidence, but is based on old studies with poor power and analysis.

ARHAI

Update

ARHAI

Update

ARHAI would like to see an analysis of the most effective form of post discharge SSI surveillance. The committee feels that this has become increasingly important as the average length of stay in hospital decreases.

British Dietetic Association

Agree

We have circulated this consultation to our membership and we have not received any

CG74 Surgical Site Infection Review Proposal for GE 020811

Thank you for your comment. Through the high-level RCT search one study was identified relating to hair removal however the evidence presented in this study was in line with the current guideline recommendation. Thank you for your comment. National surveillance systems, such as the Surgical Site Infection Surveillance System in England and similar schemes in Wales and Northern Ireland, provide standardised surveillance methods that enable hospitals to benchmark their rates of SSI. Thank you for your comment.

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CareFusion

Yes to Update

comments to indicate the need for this guideline to be reviewed at this time. With significant new evidence published since the original CG74 guideline was published, failure to update the existing guidance will result in the avoidable continuation of patients being put at risk of infections and sub-standard evidence based care.

None

None

Thank you for your comments. However, the current guideline recommendation states that skin at the surgical site should be prepared immediately before incision using an antiseptic (aqueous or alcohol-based) preparation: povidoneiodine or chlorhexidine are most suitable. This recommendation does not provide indication of a first-line antiseptic however, based on the quality of studies identified through this review process (in particular, RCTs comparing different comparators and preparations of antiseptics) there is insufficient evidence at this time to conclude which antiseptic is better. New trials comparing povidoneiodine-alcohol with chlorhexidine-alcohol will inform a future review of the guideline.

Recent audits across England have shown that in excess of 30% of surgical procedures (suitable for skin preparation with chlorhexidine gluconate in 70% isopropyl alcohol) were in fact prepared with aqueous iodine preoperatively. Based on a 5% infection rate (NICE CG74) and c.10,000,000 surgical procedures carried out per annum (HES 2009), it can be assumed, conservatively, that in excess of 30,000 SSIs could be prevented per annum if evidence based practice was implemented (i.e. 2% chlorhexidine gluconate in 70% isopropyl alcohol Darouiche R et al. N Engl J Med 2010; 362: 18-26). Review by NICE would be instrumental in influencing ongoing practice.

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This clinical area will be monitored and assessed again at the next review.

CareFusion

Yes to Update

The Cochrane review provided contrary information to the conclusion outlined on page 21, that technique in application of pre-operative skin preparations does not impact infection rates. This warrants further review of the available data and should be included in any updates to CG74

CG74 Surgical Site Infection Review Proposal for GE 020811

Thank you for your comments. However, the current guideline recommendation states that skin at the surgical site should be prepared immediately before incision using an antiseptic (aqueous or alcohol-based) preparation: povidoneiodine or chlorhexidine are most suitable. This recommendation does not provide indication of a first-line antiseptic however, based on the quality of studies identified through this review process (in particular, RCTs comparing different comparators and preparations of antiseptics) there is insufficient evidence at this time to conclude which antiseptic is better. New trials comparing povidone-

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iodine-alcohol with chlorhexidine-alcohol will inform a future review of the guideline. This clinical area will be monitored and assessed again at the next review. . Deltex Medical

Agree

Intra-operative management of patients’ vascular fluids is known to significantly reduce surgical site infections (Dalfino et al; Haemodynamic goal directed therapy and post-operative infections: earlier is better. A systematic review and meta-analysis. Critical Care 2011; 15;R154). Use of CardioQ-ODM to manage fluids during surgery improves outcomes and reduces costs by approximately £1,100 per patient undergoing major and high risk surgery (http://guidance.nice.org.uk/MTG3). The clinical guideline should be amended to incorporate this existing body of evidence of reduced surgical site infections.

Thank you for your comment. However, the description of the CardioQ-ODM in the NICE Medical Technology Guidance does not make any reference to surgical site infection as an outcome.

Department of Health

Update

There needs to be more emphasis on the general principles of the prevention of infection.

Thank you for your comment. The guideline chapters on preoperative phase (chapter 5) and Intraoperative phase (chapter 6) provide recommendations on interventions to

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prevent surgical site infections. General prevention of infection was outside the original scope of this guideline.

Department of Health

Update

In addition, the update of CG2: Infection control, prevention of healthcare-associated infection in primary and community care is ongoing with a publication date of March 2012. Thank you for your comment. The aim of the WHO Surgical Safety Checklist is to strengthen the commitment of clinical staff to address safety issues within the surgical setting. This includes improving anaesthetic safety practices, ensuring correct site surgery, avoiding surgical site infections and improving communication within the team.

There should be a reference to the WHO surgical checklist (2008).

This checklist is freely

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Department of Health

Update

It would be very helpful if the literature summary indicated which reference citations were being referred to in each section using the Vancouver system.

Healthcare Infection Society (HIS)

Agree

Clinical area 1. Intra-operative phase: antiseptic skin preparation. The discussion under ‘Summary of evidence’ is unclear, since it fails to distinguish between alcoholic and aqueous antiseptics. There is insufficient rigour in distinguishing whether alcoholic or aqueous solutions have been compared in individual studies.

available from the National Patient Safety Agency. Thank you for your comment. References are now included in the in-house review stakeholder consultation documents. Thank you for your comments. However, the current guideline recommendation states that skin at the surgical site should be prepared immediately before incision using an antiseptic (aqueous or alcohol-based) preparation: povidoneiodine or chlorhexidine are most suitable. This recommendation does not provide indication of a first-line antiseptic however, based on the quality of studies identified through this review process (in particular, RCTs comparing different comparators and preparations of antiseptics) there is

A number of studies are discussed that appear to demonstrate that chlorhexidineisopropyl alcohol is superior to (aqueous) povidone iodine. However, these are comparing two antiseptics (chlorhexidine and alcohol) against one (povidone iodine) and it is unclear which of the two agents is responsible for this effect or whether both components are important. Earlier evidence relating to skin antisepsis suggests that the alcohol component is key to delivering positive study outcomes. The key question of whether the combination of chlorhexidine plus alcohol or povidone iodine plus alcohol is superior is still unresolved. Indeed, one

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study comparing these agents showed a significant advantage for the iodinecontaining compounds.

insufficient evidence at this time to conclude which antiseptic is better. New trials comparing povidoneiodine-alcohol with chlorhexidine-alcohol will inform a future review of the guideline. This clinical area will be monitored and assessed again at the next review.

The statement ‘However, the identified new evidence on antiseptic skin preparation indicated a beneficial effect of chlorhexidine over povidone-iodine on surgical site infection rates’ in particular, needs reconsidering.

Healthcare Infection Society (HIS)

Agree

The current recommendation is likely to be misleading as it stands, as alcohol-based solutions are likely to be more effective than aqueous (whether chlorhexidine or povidone iodine). Clinical area 1. Intra-operative phase: microbial sealants. While there may be insufficient evidence to make a recommendation about microbial sealants, should the Guideline now include discussion of this intervention with the available studies, but with a comment that no recommendation can be made at the current time?

Thank you for your comment. However, only one RCT and a case-control study was identified therefore, additional RCTs are required to generate an evidence base for this intervention in the future. This will be assessed again at the next review Thank you for your comment. References are now included in the in-house review stakeholder consultation documents.

HPA Update

Page 3: Pre-operative phase: antibiotic prophylaxis. This section is largely a catalogue of RCTs; references to these are not linked, making assessment very difficult.

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There are questions around generalisability of these results for example were the RCTs done in setting analogous to the UK in terms of surgical techniques, source controls and resistance rates.

In the process of preparing the consultation document, we do not conduct a full systematic review of the literature and as such we are unable to confirm full details of the identified studies.

There are also questions around the practical implications of these trials. It is unclear why new studies have been included on non-inferiority between antibiotics given the original question concerned the effectiveness of prophylaxis compared to placebo or no prophylaxis. HPA Update

Thank you for this information.

Page 3: Lower gastrointestinal tract surgery (seven studies) Appendicectomy One RCT compared topical antibiotic application of an ionized solution compared with topical saline as a placebo for prevention of surgical site infection in appendectomy. No significant difference in frequency of surgical site infection was observed between the two groups. Neither of these (topical antibiotic nor ionized saline) are known to be a standard approach; single dose IV antibiotics are given on the view that these will prevent both intra-abdominal and surgical site infections

HPA

Thank you very much

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Update

Page 6 An RCT demonstrated no significant difference in infection rates between antibiotic prophylaxis and hand surgery. The results are unclear does this mean no difference whether or not prophylaxis was given?

CG74 Surgical Site Infection Review Proposal for GE 020811

for your comment. In the process of preparing this document, we do not conduct a full systematic review of the literature and as such we are unable to confirm full details of the identified studies. However, information obtained from the abstract of the identified RCT indicates:  This was a prospective, randomized, double-blind study including 1340 patients who were placed in one of four groups according to the components of their hands that were injured. Half of each group received antibiotics, and the other half received placebo. Infections among the placebo- and antibioticadministered

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patients did not display significant importance (p=0.759). Infections among the four groups were not statistically significant either (p=0.947). HPA Update

Page 9 Pelvis surgery (four studies) Abdominal hysterectomy An RCT was identified which compared two agents for antibiotic prophylaxis (metronidazole and ceftizoxime) of abdominal hysterectomy. No significant difference in wound infection rates was observed between the two groups. Ceftizoxime has never been available in the UK

Update

Page 9 Caesarean section A Cochrane systematic review concluded that the current evidence shows no overall difference between different classes of antibiotics in etc. This material was distributed concurrently with NICE guidance on Caesarean section which argued, cogently, against the

Thank you for this information.

HPA

CG74 Surgical Site Infection Review Proposal for GE 020811

Thank you for bringing this to our attention. The NICE guideline on Caesarean section is currently undergoing an update with an expected publication date of November 2011.

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(currently widespread) use of co-amoxiclav and in favour of first generation cephalosporins or ampicillin. These data are not mentioned here. Why? HPA Update

Thank you for this information.

Page 13 Neurosurgical procedures (one study) The efficacy of cefoperazone/sulbactam versus cefazoline [sic] for surgical prophylaxis in neurosurgery was evaluated in an RCT. No statistical difference in surgical site infection between the two groups was observed. Urologic surgery (one study) One RCT was identified which concluded that two antibiotics, cefotiam and fosfomycin were equally effective when used for antibiotic prophylaxis during urologic surgery. These antibiotics are not used widely in the UK and most would be difficult to source.

HPA Update

Thank you very much for your comment. In the process of preparing this document, we do not conduct a full systematic review of the literature and as such we are unable to confirm full details of

Page 14 Clean/clean-contaminated surgery (two studies) A systematic review compared glycopeptides with an alternative antibiotic regimen for surgical site infection prophylaxis in adults undergoing clean or clean-contaminated surgical procedures. Of two trials that reported on MRSA infection,

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neither found a significant difference between glycopeptides and comparator drugs. A meta-analysis evaluated the efficacy of ceftriaxone prophylaxis on the prevention of surgical site infections. The study concluded that ceftriaxone reduces surgical site infection rates for procedures where there is an increased risk of infection. What was the context? Background MRSA rate? What were the comparators in the former study

the identified studies. However, the reference for this systematic review is:  Chambers, D., Worthy, G., Myers, L., Weatherly, H., Elliott, R., Hawkins, N., Sculpher, M., & Eastwood, A. 2010. Glycopeptide vs. non-glycopeptide antibiotics for prophylaxis of surgical site infections: A systematic review. Surgical Infections, 11, (5) 455-462. Information on the two trials that reported MRSA infection can be obtained from the reference list of the above study.

HPA Update

Thank you for your comment however two meta-analyses, four systematic reviews and three RCTs were identified which

Page 15: Preoperative phase: mechanical bowel preparation. The recommendation states that mechanical bowel preparation should not be used routinely but did not give any guidance as to when it should be

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used. It would be helpful if indication for its use could be added.

supported the guideline recommendation that mechanical bowel preparation should not be used routinely to reduce the risk of surgical site infection. Guidelines are not a substitute for professional knowledge and clinical judgement.

HPA Update

Thank you for your comments. However, the current guideline recommendation states that skin at the surgical site should be prepared immediately before incision using an antiseptic (aqueous or alcohol-based) preparation: povidoneiodine or chlorhexidine are most suitable. This recommendation does not provide indication of a first-line antiseptic however, based on the quality of studies identified through this review process (in particular, RCTs

Page 21: Interoperative phase: antiseptic skin preparation. Results showed that chlorhexidine-alcohol was more effect than povidone-iodine, however the recommendation is for the use of either. Why not chlorhexidine-alcohol if it is more effective?

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comparing different comparators and preparations of antiseptics) there is insufficient evidence at this time to conclude which antiseptic is better. New trials comparing povidoneiodine-alcohol with chlorhexidine-alcohol will inform a future review of the guideline. This clinical area will be monitored and assessed again at the next review.

HPA Update

Page 35: The “care bundle” approach is only mentioned once and needs to be updated in line with current recommendations and practice.

Update

The evidence extracted is a good start but this needs to be converted into a resource for practice. It needs to be UK/England focused.

Update

There is a WHO surgical check list published in 2008 which should be referenced as it is very helpful and provides

Thank you for your comment. NICE does not recommend other organisations pathways or guidelines such as care bundles.

HPA

Thank you for your comment.

HPA

CG74 Surgical Site Infection Review Proposal for GE 020811

Thank you for your comment. The aim of the WHO Surgical Safety Checklist is to

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a good template. http://www.who.int/patientsafety/safesurger y/ss_checklist/en/index.html

strengthen the commitment of clinical staff to address safety issues within the surgical setting. This includes improving anaesthetic safety practices, ensuring correct site surgery, avoiding surgical site infections and improving communication within the team. This checklist is freely available from the National Patient Safety Agency. Thank you for your comment. The guideline chapters on preoperative phase (chapter 5) and Intraoperative phase (chapter 6) provide recommendations on interventions to prevent surgical site infections.

HPA Update

There should be a section on preventing infections and more specifically general infection control principles to prevent infections in this area of clinical practice.

General prevention of infection was outside the original scope of this guideline.

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Infection Prevention Society

disagree with the proposal not to update

Thank you for your comments. However, the current guideline recommendation states that skin at the surgical site should be prepared immediately before incision using an antiseptic (aqueous or alcohol-based) preparation: povidoneiodine or chlorhexidine are most suitable. This recommendation does not provide indication of a first-line antiseptic however, based on the quality of studies identified through this review process (in particular, RCTs comparing different comparators and preparations of antiseptics) there is insufficient evidence at this time to conclude which antiseptic is better. New trials comparing povidoneiodine-alcohol with chlorhexidine-alcohol will inform a future review of the guideline. This clinical area will be monitored and

Of the 6 studies reviewed on skin antisepsis, 2 RCT’s and 2 systematic reviews identified chlorhexidine/alcohol to be more effective than povidone iodine. By not updating the guidance to advise Chlorhexidine/alcohol the recommendation differs from the Saving Lives High Impact Intervention care bundle to prevent SSI. A few respondents commented on this issue. Making the change would bring consistency.

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assessed again at the next review. . NICE does not recommend other organisations pathways or guidelines such as the Saving Lives High Impact Intervention care bundle to prevent SSI.

Infection Prevention Society

disagree with the proposal not to update

This clinical area will be monitored and assessed again at the next review. Thank you for your comments. However, the current guideline recommendation states that skin at the surgical site should be prepared immediately before incision using an antiseptic (aqueous or alcohol-based) preparation: povidoneiodine or chlorhexidine are most suitable. This recommendation does not provide indication of a first-line antiseptic however, based on the quality of studies identified through this

Change may affect compliance rates for the HII for those Trusts who continue to use povidone iodine.

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review process (in particular, RCTs comparing different comparators and preparations of antiseptics) there is insufficient evidence at this time to conclude which antiseptic is better. New trials comparing povidoneiodine-alcohol with chlorhexidine-alcohol will inform a future review of the guideline. This clinical area will be monitored and assessed again at the next review. . Infection Prevention Society

disagree with the proposal not to update

The brief descriptions in the review of the studies do not make it clear if chlorhexidine/alchohol was compared with Povidone/Iodine in alcohol.

CG74 Surgical Site Infection Review Proposal for GE 020811

Thank you very much for your comment. In the process of preparing this document, we do not conduct a full systematic review of the literature and as such we are unable to confirm full details of the identified studies. However, information obtained from the abstracts of the two identified RCTs

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indicates:  Darouiche et al., 2010 compared chlorhexidinealcohol versus povidoneiodine  Paocharoen et al., 2009 compared 4% chlorhexidine versus povidoneiodine

Infection Prevention Society

disagree with the proposal not to update

One respondent identified the issue of the strength of chlorhexidine (0.5% or 2%) proposed for use. Is there any evidence available to support this?

CG74 Surgical Site Infection Review Proposal for GE 020811

Thank you very much for your comment. In the process of preparing this document, we do not conduct a full systematic review of the literature and as such we are unable to confirm full details of the identified studies. However, information obtained from the abstracts of the two identified RCTs indicates:

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



Infection Prevention Society

disagree with the proposal not to update

With significant new evidence published since the original CG74 guideline was published, failure to update the existing guidance will result in the avoidable continuation of patients being put at risk of infections and sub-standard evidence based care.

Thank you for your comments. However, the current guideline recommendation states that skin at the surgical site should be prepared immediately before incision using an antiseptic (aqueous or alcohol-based) preparation: povidoneiodine or chlorhexidine are most suitable. This recommendation does not provide indication of a first-line antiseptic however, based on the quality of studies identified through this review process (in

Recent audits across England have shown that in excess of 30% of surgical procedures (suitable for chlorhexidine alcohol prep) were in fact prepped with aqueous iodine. Based on a 5% infection rate (NICE CG74) and c.10,000,000 surgical procedures carried out per annum (HES 2009), it can be assumed, conservatively, that in excess of 30,000 SSIs could be prevented per annum if evidence based practice was

CG74 Surgical Site Infection Review Proposal for GE 020811

Darouiche et al., 2010 compared chlorhexidinealcohol versus povidoneiodine Paocharoen et al., 2009 compared 4% chlorhexidine versus povidoneiodine

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implemented. (Darouiche R et al. N Engl J Med 2010; 362: 18-26.)

particular, RCTs comparing different comparators and preparations of antiseptics) there is insufficient evidence at this time to conclude which antiseptic is better. New trials comparing povidoneiodine-alcohol with chlorhexidine-alcohol will inform a future review of the guideline. This clinical area will be monitored and assessed again at the next review. .

Review by NICE would be instrumental in influencing ongoing practice.

Infection Prevention Society

disagree with the proposal not to update

The Cochrane review provided contrary information to the conclusion outlined on page 21, that technique in application of pre-operative skin preparations does not impact infection rates. This warrants further review of the available data and should be included in any updates to CG74

CG74 Surgical Site Infection Review Proposal for GE 020811

Thank you for your comments. However, the current guideline recommendation states that skin at the surgical site should be prepared immediately before incision using an antiseptic (aqueous or alcohol-based) preparation: povidoneiodine or chlorhexidine are most suitable. This recommendation does not provide indication of a first-line antiseptic

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however, based on the quality of studies identified through this review process (in particular, RCTs comparing different comparators and preparations of antiseptics) there is insufficient evidence at this time to conclude which antiseptic is better. New trials comparing povidoneiodine-alcohol with chlorhexidine-alcohol will inform a future review of the guideline. This clinical area will be monitored and assessed again at the next review. . Infection Prevention Society

disagree with the proposal not to update

The separation or not of clean and contaminated procedures on one list is not mentioned in this paper.

Infection Prevention

disagree with the proposal not

Even if some papers see differences between wound closure techniques

CG74 Surgical Site Infection Review Proposal for GE 020811

Thank you for your comment. We decided to list the studies on antibiotic prophylaxis according to the type of surgery to maintain consistency as this format was used in the guideline. Thank you for your comment.

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Society

to update

Infection Prevention Society

Agree with the proposal not to update

Infection Prevention Society Infection Prevention Society

Agree with the proposal not to update Future research evidence needed

(staples, sutures, adhesives) the choice of closure technique used cannot be concluded purely from infection rate data in papers. The decision will be made in keeping with various parameters: urgency, patient condition, mechanical requirements, This relates to adults only. We are now carrying out surveillance for paediatrics also. The document could refer to paediatrics as well.

Needs to include paediatrics.

Thank you for your comment. The guideline scope states that the guideline includes all patients, both adults and children, undergoing surgical incisions through the skin. This includes minimally invasive surgery (arthroscopic, thoracoscopic and laparoscopic surgery). Incisional infections up to 30 days post initial procedure will be covered.

Feel there is insufficient evidence to update guidelines at present.

Thank you for your comment. In 1994, it was standard that the theatre would be cleaned (mop) between two procedures.

CG74 Surgical Site Infection Review Proposal for GE 020811

Thank you for your comment however, management of the operating theatre environment and environmental factors

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Infection Prevention Society

Future research evidence needed

Wound dressings impregnated with PHMB. Polyhexamethylene biguanide

Johnson & Johnson Medical Ltd (J&J)

Agree

Johnson and Johnson Medical (J&J) broadly agree with the proposal not to update CG74 at this time. However, it is noteworthy that Johnson and Johnson are aware of multiple comparative studies which are currently underway in the field of Intraopertaive Wound Closure methods and specifically the impact of Triclosan coated sutures on surgical site infection. With this in mind it is possible the evidence base in Intraopertive Wound Closure could develop quickly and therefore may require a review of the current guidelines ahead of the usual timeframe.

This practice has been abandoned. The guideline does not look into this to see if it brought a higher infection rate. We feel that more evidence in respect to the potential benefits of PHMB wound care products requires further review to inform practitioners

CG74 Surgical Site Infection Review Proposal for GE 020811

is outwith the guideline scope.

Thank you for your comment. This was assessed through one of the focused questions for the review of CG74 however, no studies on Polyhexamethylene biguanide were identfiied. This clinical area will be monitored and assessed again at the next review Thank you for your comment. This clinical area will be monitored and assessed again at the next review

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Mölnlycke Health Care

Agree to update

Please refer to Appendix A for our comments/suggested changes in the current guidelines.

Thank you for your comment however we do not accept unpublished studies.

RCPCH

Agree

Thank you for your comment.

RCPCH

Agree

It appears that a thorough review of recent published evidence relevant to the guideline has been carried out. No major changes to the guideline have been indicated from this. It would be helpful to know the age range of the cohorts studied; antibiotic policy, for example, may be different for neonates and children compared to adults.

RCPCH

Agree

RCPCH

Agree

Thank you very much for your comment. In the process of preparing this document, we do not conduct a full systematic review of the literature and as such we are unable to confirm details such as age range of the cohorts studied and antibiotic policy. Thank you for your comment.

Each trust providing these services will have its own antibiotic policy which should align with this national guidance; however, we are not certain to what degree trusts differentiate between treatments for children and adults. Regarding the ongoing research on the use of wound dressings impregnated with polyhexamethylene biguanide, which was highlighted by the GDG members (p34): we note that emphasising the need for, and current availability of, wound care nurses is relevant to paediatric practice.

CG74 Surgical Site Infection Review Proposal for GE 020811

Thank you for your comment. The guideline scope states that the guideline includes all patients, both adults and children, undergoing

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surgical incisions through the skin. This includes minimally invasive surgery (arthroscopic, thoracoscopic and laparoscopic surgery). Incisional infections up to 30 days post initial procedure will be covered.

The College supports the pooling of best practice into care bundles (p35). The College supports the role of clinical networks delivering surgical services for babies, children and young people. We note that both of the above issues could be best served by a networked approach to care.

Royal College of Nursing

Agree

We agree that the guideline should not be updated at this time and that it should be reviewed again according to current processes. We have no comments to make on this guideline review

United Kingdom Clinical Pharmacy Association (UKCPA) Vifor Pharma

Disagree

Malone DL, Genuit T, Tracy JK, et al. Surgical site infections: reanalysis of risk factors. J Surg Res. 2002;103:89.

Vifor Pharma

Disagree

Lee DH et al. Risk factors of surgical site infection in patients undergoing major oncological surgery for head and neck

Thank you for your comment.

Thank you for your comment.

We consider that anaemia was overlooked in the original guidance. The data is now quite conclusive that anaemia is associated with increased risk of SSI. Found that SSIs were associated with anaemia and

CG74 Surgical Site Infection Review Proposal for GE 020811

Thank you for your comment. However, this reference is outwith the date period of our review which included studies published in 2007May 2011 only.

Thank you for your comment. However, risk factors that are

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cancer. Oral Oncol (2011), doi:10.1016/j.oraloncology.2011.04.002

Vifor Pharma

Disagree

blood transfusion

significant in one type of surgery may not be generalisable to other surgical procedures. As such, the guideline includes the following research recommendation on risk factors:  Would a risk assessment tool developed by consensus methodology help predict the risk of surgical site infection? Thank you for highlighting this reference. This is insufficient evidence to warrant an update of the guideline chapter on definitions, surveillance and risk factors at this time. However, this clinical area will be monitored and assessed again at the next review

TRANSFUSION 2009;49:1964-1970 The association of preoperative anemia and perioperative allogeneic blood transfusion with the risk of surgical site infection Weber, W.

CG74 Surgical Site Infection Review Proposal for GE 020811

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