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Evidence review for ultra-clean air

Joint replacement (primary): hip, knee and shoulder

Evidence review I

NICE Guideline, No. 157

.

London: National Institute for Health and Care Excellence (NICE); .
ISBN-13: 978-1-4731-3722-6

1. Ultra clean air theatres

1.1. Review question: In adults having primary elective joint replacement or orthopaedic surgery utilising metallic implants, what is the clinical and cost effectiveness of using ultra-clean air theatres?

1.2. Introduction

Infection following hip, knee or shoulder replacement is a catastrophic complication. Microbial colonisation of the implant can result in both local and systemic sepsis. Failure to eradicate infection at an early stage can result in biofilm formation on the implant which makes it difficult to eradicate the infection with antibiotic therapy alone. In these circumstances further surgery to remove infected implants alongside debridement of infected tissue as part of a revision procedure is typically required.

There are multiple strategies to reduce the risk of infection in implant surgery. These include the use of ultra-clean air theatres in addition to other strategies. Ultra-clean air theatres are believed to reduce bacterial cell counts and surgical wound contamination within theatre. It is currently advised by the BOA and GIRFT that all arthroplasty surgery is performed in a ultra-clean air theatres.15

Recent joint registry evidence has questioned the need to use ultra-clean air theatres for all arthroplasty cases. This has prompted debate about their use and cost effectiveness. This review therefore seeks to understand the role of ultraclean air theatres and make recommendation about their ongoing use within primary elective hip, knee and shoulder joint replacement surgery.

1.3. PICO table

For full details, see the review protocol in Appendix A:

Table 1. PICO characteristics of review question.

Table 1

PICO characteristics of review question.

The population was expanded from adults having primary elective joint replacement to include orthopaedic surgery utilising metallic implants because issues around infection are common to a wider population. Infection is linked to the usage of implants during orthopaedic surgery and as these materials are not organic, it is harder for the body to kill bacteria on them.

1.4. Clinical evidence

1.4.1. Included studies

A search was conducted for randomised trials and observational studies comparing the effectiveness of ultra clean-air theatres versus conventional air flow theatres in people who are undergoing joint replacement surgery or orthopaedic surgery utilising metallic implants.

The RCT evidence found were for surgeries undertaken before 1990 and the ventilation technology in that period is considered to be of limited comparability to modern ventilation systems. Therefore it was decided to include observational evidence in the review.

Two randomised controlled trials20, 33, 35 and 7 observational studies13, 14, 18, 46, 53, 54, 59 were included in the review; these are summarised in Table 2 below. Evidence from these studies is summarised in the clinical evidence summary below (Table 3).

See also the study selection flow chart in Appendix C: study evidence tables in Appendix D: forest plots in Appendix E: and GRADE tables in Appendix H:

1.4.2. Excluded studies

See the excluded studies list in Appendix I:

1.4.3. Summary of clinical studies included in the evidence review

Table 2. Summary of studies included in the evidence review.

Table 2

Summary of studies included in the evidence review.

See Appendix D: for full evidence tables.

1.4.4. Quality assessment of clinical studies included in the evidence review

Table 3. RCT evidence summary: ultra clean-air theatres versus conventional ventilation theatres.

Table 3

RCT evidence summary: ultra clean-air theatres versus conventional ventilation theatres.

Table 4. Observational studies evidence summary: ultra clean-air theatres versus conventional ventilation theatres.

Table 4

Observational studies evidence summary: ultra clean-air theatres versus conventional ventilation theatres.

See Appendix F: for full GRADE tables.

1.5. Economic evidence

1.5.1. Included studies

One health economic study was identified with the relevant comparison and has been included in this review.24 It is summarised in the health economic evidence profile below (Table 5) and the health economic evidence table in Appendix H:

1.5.2. Excluded studies

One economic study relating to this review question was identified but was excluded due to the availability of more applicable evidence.43 It is listed in Appendix I: with reasons for exclusion given.

See also the health economic study selection flow chart in Appendix G:

1.5.3. Summary of studies included in the economic evidence review

Table 5. Health economic evidence profile: 8 different combinations of infection prevention strategies after total hip replacement versus no infection prevention.

Table 5

Health economic evidence profile: 8 different combinations of infection prevention strategies after total hip replacement versus no infection prevention.

1.5.4. Unit costs

Relevant unit costs are provided below to aid consideration of cost effectiveness.

Table 6. UK costs of laminar airflow in operating rooms.

Table 6

UK costs of laminar airflow in operating rooms.

1.6. Evidence statements

1.6.1. Clinical evidence statements

Evidence from 2 randomised controlled trials and 7 observational studies reported on infection prevention in joint replacement surgery through the use of ultra clean-air ventilation compared to conventional ventilation. 1 RCT (very low quality, n=6050) found no difference in deep surgical site infection. The second RCT was analysed using the original randomised groups and found a benefit of ultra clean-air in confirmed sepsis (very low quality, n=8055). This same evidence was also sub-grouped in 2 ways. The first where all people were given prophylactic antibiotics and ultra clean-air operating teams either wore body exhaust suits or conventional clothing and that found a benefit of ultra clean-air in confirmed sepsis (very low quality, n=5831). The second where all people given prophylactic antibiotics and ultra clean-air operating teams wore conventional clothing found no clinically important difference between interventions in confirmed sepsis (very low quality, n=4247). Evidence from observational studies was not meta-analysed due to control of different confounding factors and variation in data gathering of the outcome of interest. 2 studies reported revision due to infection and one found no clinical difference and the other found a benefit for conventional ventilation (very low quality, n=80,756–97,344). 5 studies reported on surgical site infection across 8 outcomes and 4 indicated no clinical difference and 4 indicated a clinically important benefit of conventional ventilation (low to very low quality, n=6,848–85,609). No evidence was available for 30-day mortality or quality of life.

1.6.2. Health economic evidence statements

One comparative cost utility analysis found that use of laminar airflow in theatres was: dominant (less costly and more effective) compared to not using any other infection prevention strategy; not cost effective when used as an adjunct to systemic antibiotics; dominated when used as an adjunct to systemic antibiotics and antibiotic impregnated cement; and dominated (cost more and less effective) when used as an adjunct to systemic antibiotics, antibiotic impregnated cement and body exhaust suits. This analysis was assessed as partially applicable with potentially serious limitations.

1.7. The committee’s discussion of the evidence

1.7.1. Interpreting the evidence

1.7.1.1. The outcomes that matter most

The critical outcomes are 30-day mortality, quality of life, deep surgical site infection and superficial surgical site infection. The choice of ventilation systems used during orthopaedic surgery with implants was made based on the concept of reduction of infection. This review includes 2 critical outcomes on infection. The committee spoke about the devastating possibilities to the person who has surgical site infection after joint replacement surgery. Addressing these infections is a significant cost to the NHS. Infections can recur after they initially happen, and a committee member spoke about people being operated on 9 or 10 times due to infection.

The important outcomes are also designed to pick up the negative impacts of infection through return to theatre, hospital readmission, and length of stay.

No evidence was found for the following critical outcomes: 30-day mortality or quality of life.

1.7.1.2. The quality of the evidence

All of the outcomes were judged to be low or very low quality.

The RCT evidence was at very high risk of bias. The method of randomisation was unclear, there was imprecision for one outcome and the data was not directly applicable to current practice for 2 others due to intermittent use of prophylactic antibiotics and body exhaust suits.

Subgroup data was also presented from 1 RCT and it should be noted that this breaks randomisation. This subgroup is more relevant to current practice as it relates to people who were given prophylactic antibiotics and where the operating room staff did not wear body exhaust suits. However, the decision to give antibiotics was made by the operating surgeon and the decision to use body exhaust suits was based on local hospital policy. All the evidence from the RCTs were deemed to be of very low quality.

Much of the observational data was from registries and was consequently influenced by confounding factors. These factors were numerous but included surgeon experience and effectiveness, type of prosthesis, duration of operation, and variations in the clinical condition of people selected for ultra clean-air or conventional ventilation. Only studies that used multivariate analysis to address confounding factors were included and the factors adjusted for varied between studies. In addition, infection reporting policies, revision policy, diagnostics, and surgeon awareness, could influence the results. All outcomes were downgraded to very low quality for risk of bias due to unclear control of important confounding factors or for imprecision around the resulting effect estimate.

1.7.1.3. Benefits and harms

The committee spoke about the consequences of surgical site infection after joint replacement surgery. It can be a catastrophic complication and lead to considerable morbidity and cause amputation or revision surgery. Also people are more likely to have further infections after joint replacement surgery if it has happened before.

2 RCTs were included in the evidence review. All surgeries in both trials were completed before 1990. Personnel isolator systems (body exhaust suits) were occasionally utilised in 1 RCT but not in the other. Similarly, 1 RCT gave all people prophylactic antibiotics, and the other study gave prophylactic antibiotics to 72% of people in the study. The operating surgeon made the decision on whether they should be administered. The original randomised data from this trial and 2 additional subgroup analyses were presented. These 2 subgroups contain only people who were given prophylactic antibiotics and in 1 case only people operated on by staff who were not wearing body exhaust suits. These 2 subgroups are a closer match to how current NHS joint replacement surgery is undertaken than the original randomised intervention groups. The RCT outcomes varied in clinical importance and no meta-analysis was undertaken due to variation in care and the breaking of randomisation though subgroup analysis. The study where prophylactic antibiotics were given to all people and surgery was completed without the use of personnel isolator systems did not find a clinically important benefit of ultra clean air in deep surgical site infection.

However, it was mentioned that this study used a horizontal laminar flow system and these are harder to run effectively. The other RCT found a clinically important benefit of ultra clean air with the truly randomised data (72% of people having prophylactic antibiotics and body exhaust suits occasionally worn) and a clinically important benefit in the subgroup of people who all had prophylactic antibiotics and body exhaust suits occasionally worn. However, there was no clinically important benefit in the subgroup of people who had prophylactic antibiotics and body exhaust suits were not worn. All surgery undertaken in the 2 RCTs were completed before 1990. The committee agreed that ultra clean air systems utilised in the 1980s are different from those used today, and the conventional ventilation systems likewise are different from today’s turbulent ventilation, as they exist today. Thus, the committee could not draw firm conclusions on the effectiveness of ultra clean air from the RCT data.

A number of other systematic reviews investigating ventilation systems during joint replacement surgery had excluded studies undertaken before 1990 due to the technology in that period being outdated by modern standards. The committee agreed that it would be prudent to include more recent observational studies that use multivariate analysis to control for confounding factors.

Seven observational studies were included; these analysed data from national registries and surveys and consequently encompassed very large numbers of people. NJR data would have only been considered if it was adjusted for confounding factors. Five outcomes, 1 revision due to infection and 4 surgical site infection outcomes indicated no clinically important difference. Five outcomes, 1 revision due to infection and 4 surgical site infection outcomes indicated a clinically important benefit for conventional ventilation over ultra clean-air. The imprecision of the studies was noted. The confidence intervals, where reported, of all outcomes crossed at least 1 minimally important difference (MID) and 3 outcomes crossed both MIDs. The committee spoke of the importance of the follow-up in terms of picking up the number of surgical site infections accurately. Studies reporting on revision due to infection followed up people for the length of the studies and this was 0 to 14 years in 1 case and 0 to 20 years in the other. The surgical site infection outcomes varied more. Five outcomes from the KISS registry were followed-up in routine post discharge surveillance, and this was variable. Two outcomes were limited to infections within 1 year of surgery and 1 outcome within 90 days of surgery. The committee did not consider periods under 2 years to be sufficient to give an accurate picture of infection after joint replacement surgery. Deep infection often presents late and diagnosis can be difficult. This could be missed in registry data whereas RCTs, where infection is the most significant outcome, may be more focussed on accurately collecting this follow-up data. The committee also spoke about the collection of registry data. It is not a comprehensive enough process to give an accurate summary of the infection risk of ventilation systems in operating theatres. A further weakness was the usage of ‘infections that lead to revision’ as an outcome. A committee member did not consider this to be an effective way to judge the number of infections as many infections happen that lead to negative outcomes but not necessarily revision surgery.

The committee indicated that the ventilation technology used in the 2 RCTs may not accurately represent either ultra clean-air or conventional ventilation as they stand today. They also agreed the registry data utilised in the observational studies was flawed. The committee consensus was that ultra clean-air ventilation is more effective at reducing surgical site infections than conventional turbulent air ventilation and the inconclusive results of the evidence review were not strong enough to alter current practice. The current BOA Consultant Advisory Book (2014) recommends that ultra clean-air vertical laminar flow systems or equivalent are mandatory for joint replacements and major orthopaedic implant surgery. In line with standard orthopaedic UK practice, the committee’s assessment of the evidence and consensus, a recommendation was made to use ultra clean-air ventilation for primary joint replacement surgeries.

It was also noted by the committee that the observational studies included did not always report whether people received prophylactic antibiotics.

1.7.2. Cost effectiveness and resource use

One economic study was found which suggested that when antibiotic prophylaxis (or any other infection prevention strategy) is not used, laminar airflow is cost effective. This highlights the importance of whether antibiotic prophylaxis is used routinely or not. In current practice, antibiotics are commonly used; however, the issue of antibiotic resistance may change guidance on the use of antibiotics. The study also suggested that when other infection prevention strategies are used, the addition of laminar flow is not cost effective. This model was based on a mixture of randomised and observational evidence that only partially overlapped with the evidence in this guideline’s clinical review.

The unit costs presented for laminar flow were for construction and installation and therefore concerned new builds. A few committee members agreed that the unit cost for the new build seemed less expensive than what they had expected. The costs presented had limited applicability in that the estimate was from the USA and for 2011/12. Committee members thought that it could be more relevant to focus on the cost effectiveness of building additional laminar airflow theatres. It was not known exactly how many hospitals do not have laminar flow operating theatres; however, their use is widespread and considered current practice. Installation of new ultra clean-air facilities may have an initial resource impact; however, running costs once built would be minimal. It was suggested that anecdotally over the lifetime of a theatre, it would be surprising if the use of laminar airflow costed more than £2–3 per person over conventional ventilation. Therefore, where laminar flow operating theatres already exist, their use does not have a large resource impact. Alternatively, if a recommendation were made against the use of the intervention, there would also be a cost associated with dismantling the existing laminar airflow operating theatres. There may be additional costs to the NHS due to emergency surgery overflow reducing elective capacity. This means that, at times, private facilities with ultra clean-air theatres must be hired out in order to carry out elective joint replacement procedures. However, these costs also form part of current practice.

The poor quality and conflicting results of the clinical RCT and observational data (as discussed in Section1.7.1) means that it was not possible to draw conclusions about the effectiveness or cost effectiveness of ultra clean air compared with conventional ventilation from the evidence. The committee also agreed that original cost effectiveness modelling would not be informative for their decision, since it would have to be based on the existing flawed clinical effectiveness evidence base.

The committee consensus was that ultra clean-air ventilation is more effective at reducing surgical site infections than conventional turbulent air ventilation and the inconclusive results of the evidence review were not strong enough to alter current practice. A recommendation was made to use ultra clean-air ventilation for primary joint replacement surgeries. As recommending the use of ultra clean air theatres will not change current practice, no resource impact is expected.

1.7.3. Other factors the committee took into account

The committee discussed the theoretical advantages of ultra clean air systems. They have been shown to reduce bacterial colonies settling and it is believed that this consequently reduces surgical site infection.

It was also noted that there are other known factors that are thought to influence the occurrence of infection. Airborne bacteria that cause infections can still be present after previous operations and this is particularly associated with ‘dirty’ surgery such as gastrointestinal surgery or surgery on ischaemic vascular limbs. The bacteria left by these types of surgery are believed to present a much higher infection risk for joint replacement surgery. Thus having dedicated orthopaedic operating rooms where such surgeries do not occur are very important to infection control.

The committee also discussed the increase in antimicrobial resistance. 1 RCT did indicate a more pronounced effect of ultra clean-air when including people with and without prophylactic antibiotics. Therefore, rising antibiotic resistance could make the effect of ultra clean-air more important if this continues.

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Appendices

Appendix B. Literature search strategies

The literature searches for this review are detailed below and complied with the methodology outlined in Developing NICE guidelines: the manual.47

For more detailed information, please see the Methodology Review.

B.1. Clinical search literature search strategy

Searches were constructed using a PICO framework where population (P) terms were combined with Intervention (I) and in some cases Comparison (C) terms. Outcomes (O) are rarely used in search strategies for interventions as these concepts may not be well described in title, abstract or indexes and therefore difficult to retrieve. Search filters were applied to the searches where appropriate.

Table 9. Database date parameters and filters used

Medline (Ovid) search terms

Embase (Ovid) search terms

Cochrane Library (Wiley) search terms

B.2. Health Economics literature search strategy

Health economic evidence was identified by conducting a broad search relating to joint replacement population in NHS Economic Evaluation Database (NHS EED – this ceased to be updated after March 2015) and the Health Technology Assessment database (HTA) with no date restrictions. NHS EED and HTA databases are hosted by the Centre for Research and Dissemination (CRD). Additional health economics searches were run in Medline and Embase.

Table 10. Database date parameters and filters used

Medline (Ovid) search terms

Embase (Ovid) search terms

NHS EED and HTA (CRD) search terms

Appendix D. Clinical evidence tables

Download PDF (371K)

Appendix H. Health economic evidence tables

Download PDF (178K)

Appendix I. Excluded studies

Final

Intervention evidence review underpinning recommendation 1.5.2 in the NICE guideline

This evidence review was developed by the National Guideline Centre, hosted by the Royal College of Physicians

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 2020.
Bookshelf ID: NBK561386PMID: 32881464

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