Mepilex Border Heel and Sacrum dressings for preventing pressure ulcers

Having considered the various meta-analyses done by the EAC, the committee preferred the meta-analysis of the 3 randomised controlled trials and concluded that any benefit provided by Mepilex Border Sacrum in preventing sacral pressure ulcers was of borderline statistical significance. The committee also noted that there was limited robust evidence on the clinical effectiveness of Mepilex Border Heel; indeed, only 1 observational study reported positive results for the Mepilex Border dressing. The committee concluded that Mepilex Border Sacrum is at best marginally effective, and that the effectiveness of Mepilex Border Heel remains uncertain.

The incidence of pressure ulcers with standard care is an important factor in determining the potential of Mepilex Border dressings. The clinical experts highlighted that there is variation in reported pressure ulcer incidence rates across the NHS; this is likely because of variation in how best practice to prevent pressure ulcers is implemented. However, they explained that preventing pressure ulcers is a priority for all NHS trusts and the incidence of pressure ulcers seems to be reducing through the widespread use of standard bundles of care. The EAC provided estimates of pressure ulcer prevalence from NHS safety thermometer data, but the committee concluded that there remains uncertainty because of the failure to capture grade 1 pressure ulcers and the voluntary nature of data submission. Proposed changes to reporting measures will also affect the future reported incidence rates and hopefully improve the consistency and completeness of the data. Based on the available data, the committee concluded that the proportion of patients at risk of developing a new heel or sacral pressure ulcer in an acute care NHS setting is likely to be close to 3.8% (as estimated by the EAC), but that this is likely to decrease over time.

All 4 randomised controlled trials were done outside the UK. The clinical experts explained that because of international guidelines on preventing pressure ulcers, overall standards of care are likely to be relatively consistent across different countries. Nonetheless, there may still be differences in terms of patient selection, length of hospital stay, staff ratios and the exact composition of care bundles. The committee noted the relatively high baseline incidence rate of pressure ulcers in the control arm of the trials compared with the EAC's estimate for the incidence in the NHS. It also noted that any benefits associated with Mepilex Border dressings observed in the trial were based on a small absolute number of pressure ulcer events. Moreover, the committee was aware that assessing and grading heel and sacral pressure ulcers is subjective, and the clinical experts confirmed that this often depends on individual staff experience. Healthcare professionals will often seek a second opinion to avoid the consequence of incorrect grading, and the availability of specialist tissue viability nurses across the NHS varies. The clinical experts confirmed that NHS acute care settings include a broad range of patients at risk of pressure ulcers, and that staff across different clinical areas will have different levels of expertise in preventing and recognising early evidence of pressure ulcers. Having considered these factors, the committee concluded that there were uncertainties about the generalisability of the evidence to NHS practice.

The clinical experts explained that little training is needed to be able to apply Mepilex Border dressings. Some clinical experts noted that because of the cost of the specific Mepilex Border Sacrum and Heel variants, the less costly standard rectangular Mepilex Border dressings are sometimes used and instead cut to the appropriate shape. However, this may limit the effectiveness of the dressings and mean that they need to be changed more often. The committee noted that this improvised use is not included in the manufacturer's instructions for use. It concluded that healthcare professionals should use the appropriate dressing for the specific location of the pressure ulcer.

The clinical experts agreed that not all patients in acute care should have Mepilex Border dressings, but they described uncertainty in terms of best patient selection. They explained that it has not yet been determined how to identify patients for whom Mepilex Border dressings would be most suitable. The committee agreed that the evidence available does not allow for accurate patient selection and that further research would be helpful in this regard. The committee also noted that evidence was generated in other settings which are not covered by the scope of this evaluation.

The committee accepted the EAC's changes to the company's cost model (see section 3.6), and considered that the revised parameters better reflected costs and resource use in an NHS acute care setting. However, it noted that uncertainties remained with regard to important factors such as the incidence of pressure ulcers and how often dressings needed to be changed. The committee concluded that the cost consequences associated with Mepilex Border Heel and Sacrum were uncertain and that further research would help to inform more accurate cost modelling.

Cost savings in the updated model were mainly driven by the incidence of pressure ulcers in the standard care arm and the frequency of dressing changes. The committee recalled that pressure ulcer incidence rates may be lower in the NHS than those used in the model (see section 4.2). The committee also understood that according to the instructions for use, Mepilex Border Heel and Sacrum dressings should be changed every 3 days. However, the clinical experts explained that in certain patient groups, such as people with faecal or urinary incontinence, the dressings may need to be changed more often. The committee concluded that resource use data from clinical practice would help to inform more accurate cost modelling.

The EAC's updated cost model reported that compared with standard care, using Mepilex Border Heel and Sacrum may save around £19 per patient. However, the committee concluded that any proposed cost savings should be interpreted with caution because of the uncertainties in the cost modelling (see section 4.7).

The committee concluded that Mepilex Border Heel and Sacrum dressings show promise, and that further research should be done to help resolve the uncertainties about clinical effectiveness and cost modelling. This research should also evaluate the incidence of pressure ulcers in patients at risk or high risk of pressure ulcers in an acute care setting, despite having standard care to prevent pressure ulcers. The research should explore any benefits that Mepilex Border dressings may offer in addition to standard care for preventing heel and sacral pressure ulcers. Data from this research, combined with data from use of dressings in clinical practice, should allow conclusions to be drawn about which patients will benefit most, as well as practical considerations such as how often the dressings should be changed.