Joint Replacement (Primary): Hip, Knee and Shoulder [H] Evidence Review for Wound Lavage

National Institute for Health and Care Excellence Draft for consultation Joint replacement (primary): hip, knee and shoulder [H] Evidence review for wound lavage NICE guideline Intervention evidence review October 2019 Draft for Consultation This evidence review was developed by the National Guideline Centre, hosted by the Royal College of Physicians Joint replacement: DRAFT FOR CONSULTATION Contents Disclaimer The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and, where appropriate, their carer or guardian. Local commissioners and providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties. NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the Welsh Government, Scottish Government, and Northern Ireland Executive. All NICE guidance is subject to regular review and may be updated or withdrawn. Copyright © NICE 2019. All rights reserved. Subject to Notice of rights ISBN Joint replacement: DRAFT FOR CONSULTATION Contents Contents 1 Wound lavage ............................................................................................................... 5 1.1 Review question: In adults having primary elective joint replacement, what is the clinical and cost effectiveness of antibiotic or antiseptic wound lavage during the procedure? ........................................................................................... 5 1.2 Introduction ........................................................................................................... 5 1.3 PICO table ............................................................................................................. 5 1.4 Clinical evidence ................................................................................................... 6 1.4.1 Included studies ......................................................................................... 6 1.4.2 Excluded studies ........................................................................................ 6 1.5 Economic evidence ............................................................................................... 7 1.5.1 Included studies ......................................................................................... 7 1.5.2 Excluded studies ........................................................................................ 7 1.5.3 Unit costs ................................................................................................... 7 1.6 Evidence statements ............................................................................................. 8 1.6.1 Clinical evidence statements ...................................................................... 8 1.6.2 Health economic evidence statements ....................................................... 8 1.7 The committee’s discussion of the evidence .......................................................... 8 1.7.1 Interpreting the evidence ............................................................................ 8 1.7.2 Cost effectiveness and resource use ......................................................... 9 1.7.3 Other factors the committee took into account ........................................... 9 Appendices ........................................................................................................................ 12 Appendix A: Review protocols ................................................................................... 12 Appendix B: Literature search strategies ................................................................... 21 B.1 Clinical search literature search strategy ...................................................... 21 B.2 Health Economics literature search strategy ................................................. 27 Appendix C: Clinical evidence selection ..................................................................... 30 Appendix D: Health economic evidence selection ...................................................... 32 Appendix E: Excluded studies.................................................................................... 34 E.1 Excluded clinical studies ............................................................................... 34 4 Joint replacement: DRAFT FOR CONSULTATION Wound lavage 1 1 Wound lavage 1.1 2 Review question: In adults having primary elective joint 3 replacement, what is the clinical and cost effectiveness of 4 antibiotic or antiseptic wound lavage during the 5 procedure? 1.2 6 Introduction 7 Wound lavage or irrigation is a washout process routinely used during surgery when 8 performing hip, knee and shoulder replacements. It is used to remove contamination and 9 debris from the site of an operation during the procedure. It is seen as a key part of joint 10 replacement surgery. 11 In so doing this enables: 12 1) the clinician to have a clear view of the site. 13 2) the exposure and preparation of bone surfaces - allowing the adhesive cement, used 14 in the procedure, to penetrate the bone enabling a solid and lasting fix (of the implant). 15 3) the removal of debris that, potentially, might pass into the blood stream and so to 16 another site in the body. 17 4) a reduction in microbial contamination of the operative site, potentially reducing 18 infection. 19 The solution used to washout the area of surgery during joint replacement surgery varies; 20 usually influenced by the surgeon’s preference: normal saline, an antiseptic solution or a 21 solution containing antibiotics can be used. However, what is not known is whether the 22 addition of antibiotics and/or antiseptic solutions to the wound lavage fluid help to reduce the 23 risk of infection more effectively than using wound lavage with normal saline solution, alone. 24 This review focuses on whether antiseptic and/or antibiotic components, when added to the 25 irrigation fluid, are clinically and cost effective when compared to irrigation with saline alone. 1.3 26 PICO table 27 For full details, see the review protocol in appendix A. 28 Table 1: PICO characteristics of review question Population Adults having primary elective joint replacement. Interventions Wound lavage with saline and antiseptic agent(s) Wound lavage with saline and antibiotic agent(s) Wound lavage with saline and antiseptic and antibiotic agents Comparisons Wound lavage with saline Outcomes Critical Mortality at 30 days Quality of life Superficial Surgical site infection Deep surgical site infection © NICE 2019. All rights reserved. Subject to Notice of rights 5 Joint replacement: DRAFT FOR CONSULTATION Wound lavage Important Return to theatre Allergic reaction Adverse antibiotic reactions Hospital readmission Pain Length of stay Study design Randomised controlled trials If no well-conducted RCTs are available, then observational studies with multivariate analysis will be investigated. 1.4 1 Clinical evidence 1.4.1 2 Included studies 3 No relevant clinical studies were identified comparing saline wound lavage with an additional 4 antiseptic and/or antibiotic agent to saline wound lavage without additional agent in adults 5 having primary elective joint replacement. The searches looked for both RCTs and also non- 6 randomised studies. 7 8 See also the study selection flow chart in appendix C, study evidence tables in appendix D, 9 forest plots in appendix E and GRADE tables in appendix H. 1.4.210 Excluded studies 11 See the excluded studies list in appendix I. 12 13 © NICE 2019. All rights reserved. Subject to Notice of rights 6 Joint replacement: DRAFT FOR CONSULTATION Review protocols 1.5 1 Economic evidence 1.5.1 2 Included studies 3 No relevant health economic studies were identified. 1.5.2 4 Excluded studies 5 No health economic studies that were relevant to this question were excluded due to 6 assessment of limited applicability or methodological limitations. 1.5.3 7 Unit costs 8 Relevant unit costs are provided below to aid consideration of cost effectiveness. 9 Table 2: UK costs for irrigation solution composition Cost (per Active Ingredient Size Unit Cost litre) Sodium chloride 9 mg per 1 ml(a) 1000ml £1.09 £1.09 Chlorhexidine gluconate 5 mg per 1 ml 600ml £4.72 £7.87 Chlorhexidine gluconate 40 mg per 1 ml 500ml £5.25 £10.50 Povidone-Iodine 75 mg per 1 ml 500ml £7.67 £15.34 Vancomycin (as Vancomycin (b) 500mg £6.25 £13.59 hydrochloride) 10 Source: Joint Formulary Committee9 11 (a) Costs only available for 1L bags when 3L more commonly used 12 (b) When used as a concentration of 1g/L, cost includes 1L saline solution

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