NICE has published final medical technology guidance on two different technologies which are found to be promising – but which both need more evidence on their use in clinical practice before they can be supported for routine use in the NHS.
The first guidance covers the ReCell Spray-On Skin system, a device that aims to help improve the healing of acute burns. The ReCell system uses a small piece of the patient’s skin to create a solution containing a suspension of skin cell components which is then sprayed on to the site of the burn. The cells in the suspension then multiply quickly and embed themselves in the base of the wound. The regenerative nature of these skin cells is intended to encourage the growth of healthy skin so that the burn wound can heal rapidly.
The benefits which the ReCell system manufacturer claims that the device can provide include shorter wound healing time, weekly rather than daily dressing changes allowing a shorter stay in hospital, less likelihood of scarring and better matching of skin colour, and a reduction in skin graft donor site size and depth.
The NICE Medical Technologies Advisory Committee’s decision is that the ReCell system shows promise, but there is not yet enough evidence on its use in clinical practice to enable a recommendation for it to be used routinely in the NHS. The Committee therefore recommends that research is undertaken to address uncertainties about the clinical and cost benefits of the device, and to identify which patients might benefit most from its use in the NHS. Specific clinical outcomes such as how long it takes for the burn to become 95% healed, and function of the burned area, should be included.
The second piece of guidance is on Parafricta Bootees and Undergarments which aim to reduce skin damage in people with frail skin or who have, or are at risk of, pressure ulcers.
In the UK, chronic wounds represent a significant burden to patients and the NHS. Some 200,000 patients in the UK have a chronic wound. This includes leg ulcers, foot ulcers, and pressure ulcers.
Parafricta Bootees provide protection for the heel and ankle, and the Undergarments provide protection for the base of the spine, buttocks and hips. The garments are made from the manufacturer’s own brand Parafricta fabric which is designed to reduce the shear stress and friction associated with movement between the fabric and skin. As less force is exerted on the skin by the fabric, this reduces the risk of the skin being damaged, which in turn reduces the risk of pressure ulcers. This way of reducing risk of pressure ulcers is different from current alternative prevention or management methods, which focus on reducing or redistributing pressure on an area of the body. As well as reducing incidence of pressure ulcers, benefits claimed for the garments include shorter stays in hospital which may allow people to be transferred to lower cost community care.
The Committee recognises that Parafricta Bootees and Undergarments show potential to reduce the development and progression of skin damage caused by friction and shear in people with, or at risk of, pressure ulcers. However more evidence for their effectiveness in clinical practice is needed before their routine use in the NHS can be supported. In the guidance, the Committee recommends that research is carried out to address uncertainties in the benefits that the manufacturer claims would result for patients and the NHS. The recommended research should compare the garments against standard care, and preferably be carried out in a hospital. It should include development of criteria to recognise which people in both hospitals and community care would benefit most from the garments.
Professor Carole Longson, director of the NICE centre for health technology evaluation, said: “The NICE Medical Technologies Advisory Committee has evaluated two promising technologies: the ReCell Spray-On Skin system for improving healing in acute burns, and Parafricta Bootees and Undergarments for reducing skin damage in people with frail skin or at risk of pressure ulcers. In the two pieces of final medical technology guidance, the Committee concluded that in both cases more evidence of the potential benefits is needed before they could be supported for routine use in the NHS.
“As around 12,000 people each year have burns wounds which require hospital admission, which sometimes involve long hospital stays, and 200,000 patients in the UK have a chronic wound, there are a large number of people who may benefit from innovative devices to manage these conditions. The guidance recommendations for further research means that NICE will now explore the development of appropriate further evidence, in collaboration with the technology sponsor and with clinical and academic partners.
“It’s essential to note that these recommendations for further research don’t mean that these promising technologies should not be used, as it’s important that more data can be generated to help inform further considerations on their clinical utility. NICE will update both pieces of guidance if and when substantive new evidence becomes available.”