Plus Sutures for preventing surgical site infection

The evidence base for Plus Sutures is large, of relatively high quality and is likely to be generalisable to the NHS. Some of the individual studies did not show a significant reduction in surgical site infection incidence for Plus Sutures. However, when all results were combined in the meta-analyses, the effect was significant. Additional analyses done by the external assessment centre (EAC) showed that the size of effect was smaller when studies were stratified by quality or sample size. But it was not possible to determine if this was because of the effect measured in the studies or because of the small number of studies included in the analyses. The committee concluded that, although the effect size may vary depending on population and type of procedure, the evidence showed that Plus Sutures is likely to lead to overall reductions in surgical site infections.

No significant device-related adverse events were identified from the published evidence. The clinical experts noted that triclosan is safe and is used in many consumer products, at much higher concentrations and amounts than in Plus Sutures. None of the clinical experts had encountered anyone who had an allergic reaction to triclosan in Plus Sutures. The committee concluded that using Plus Sutures is safe and that adverse or allergic reactions to triclosan are likely to be very rare. The committee discussed antimicrobial stewardship considerations and concluded that neither the product nor concentration of triclosan raised concerns about resistance.

The committee discussed equality considerations for the use of Plus Sutures in the general population. The instructions for use highlight that 'absorbable sutures, including Plus Sutures may not be appropriate for older people, those who are malnourished, debilitated or have conditions that may prevent wound healing'. The clinical experts explained that a number of factors must be taken into consideration by the surgeon choosing the suture, including comorbidities, surgery type, tissue type and condition. The committee concluded that these were factors that surgeons would consider within the patient assessment for appropriate management plans. It did not consider there to be any equality issues as a result of its recommendations.

The clinical experts noted that, in their experience, Plus Sutures was most effective at reducing infections in deep and superficial tissue layers, rather than deep organ space tissues. However, the experts stated that while using Plus Sutures has been shown to reduce surgical site infection risk, to maximise their effect, they should be used alongside an appropriate care bundle for surgical site infection prevention, including antibiotic use, appropriate hair removal, glycaemic control and normothermia. The clinical experts reported their experience that introducing Plus Sutures to the surgical site infection prevention care bundle had resulted in fewer surgical site infections. The committee concluded that Plus Sutures should be used as part of a bundle of care to reduce surgical site infections.

The evidence on Plus Sutures was from hospitals. However, the committee noted that some GP clinics provide minor surgery services and use broadly the same care bundles for infection prevention as used in hospitals. The committee stated that the evidence collected in secondary care is likely to be largely generalisable to primary care settings. The committee concluded that Plus Sutures could be considered in GP minor surgery clinics.

The clinical experts advised that no further training is needed to use Plus Sutures compared with non-triclosan sutures. The addition of triclosan does not change the absorption profile when identifying the appropriate suture or change the handling of the suture itself. Clinical experts reported that the handling properties of Plus Sutures were identical to non-triclosan sutures and no modification of existing procedures is needed. The committee concluded that adopting Plus Sutures would not need a change to services.

The committee noted that the EAC made minor changes to the cost model, which were appropriate and accepted. The committee concluded that the comprehensive subgroup and sensitivity analyses supported cost savings in all subgroups.

The committee discussed the estimated cost of surgical site infections and accepted the use of a UK study, which reported the cost savings associated with surgical site infections in hospitals (Jenks et al. 2014). Reduction in surgical site infection was the main driver for the cost savings. The committee concluded that the cost savings were likely to be realised in practice and were supported by the evidence and experience of the clinical experts.

The committee discussed the comprehensive scenario analyses completed by the company and EAC, which showed Plus Sutures reduced the risk of surgical site infections in most scenarios. It accepted that results from the subgroups in which statistical significance was reduced should be interpreted with caution because the smaller sample sizes affect the analysis. The committee concluded that Plus Sutures is likely to save costs in most scenarios and that the scenarios at which costs break even are clinically unlikely.

The committee discussed the potential for further cost savings in the community as a result of fewer hospital-acquired surgical site infections and therefore less need for follow-up care, which was not captured in the economic model. The committee agreed with the company and the EAC that the cost savings in the cost modelling are likely to be conservative.

The committee was satisfied that the cost-modelling evidence indicates that Plus Sutures is cost saving compared with non-triclosan absorbable sutures by an average of £13.62 per patient. The committee concluded that the sensitivity analyses showed that Plus Sutures remained cost saving across all subgroups.