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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 Undergarmentswhich 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.”

For more information call Dr Tonya Gillis at the NICE press office on 0300 323 0142, or out of hours on 07775 583 813.

Notes to Editors

About the NICE guidance

• The medical technologies guidance, ‘The ReCell Spray-On Skin system for treating skin loss, scarring and depigmentation after burn injury’, is available athttp://www.nice.org.uk/guidance/mtg21 and ‘Parafricta Bootees and Undergarments to reduce skin breakdown in people with or at risk of pressure ulcers’ is at http://www.nice.org.uk/guidance/mtg20 from Wednesday 12 November.

About the ReCell guidance

• The ReCell Spray-On Skin system is manufactured by Avita Medical.
• The cost of ReCell as stated in the sponsor’s submission is £950 plus VAT per pack. ReCell is supplied as a sterile pack containing all the components needed to create and apply a skin cell suspension sufficient to treat up to 320 cm2 of skin.
• There are an estimated 250,000 patients each year with acute wounds caused by burns. In England in 2011/12 there were 12,213 hospital admissions for burns and corrosions (chemical burns), of which 9043 were emergency admissions.
• A skin graft is the standard management for burn wounds which are full thickness (where the epidermis, dermis and subcutaneous layer, and in some cases the underlying muscle or bone, are affected) and more than 1cm diameter, as the regenerative components of the skin will have been lost because of the severity of damage. Skin grafting can also be used to treat deep partial thickness burns which have not healed, or are not expected to heal, in 14-21 days. Superficial burns which affect the epidermis only (such as sunburn) and superficial partial thickness burns usually heal without surgical intervention within a few weeks.

About the Parafricta guidance

• Parafricta Bootees and Undergarments are manufactured by APA Parafricta.
• The cost of each Parafricta Bootee stated in the sponsor’s submission is £35.14 (excluding VAT). The cost of the Parafricta Undergarment stated in the sponsor’s submission is also £35.14 (excluding VAT). Parafricta garments are prescribable on a standard FP10 prescription.

About the Medical Technologies Evaluation Programme

• The focus of the Medical Technologies Evaluation Programme is specifically on the evaluation of innovative medical technologies, including devices and diagnostics. The types of products which might be included are medical devices that deliver treatment such as those implanted during surgical procedures, technologies that give greater independence to patients, and diagnostic devices or tests used to detect or monitor medical conditions. The independent Medical Technology Advisory Committee has two core remits: selecting medical technologies for evaluation by NICE guidance programmes and also developing medical technologies guidance itself. NICE medical technology guidance aims to help new medical technologies, or innovative modifications to existing ones, to be used more quickly and consistently in the NHS across England. In particular, the evaluation process looks at whether a device offers benefits to the patient and the NHS at a lower cost compared with similar products, or increased benefits for equal cost. The guidance applies to the NHS in England, and is not mandatory. More information is available at http://www.nice.org.uk/MT.

About NICE

The National Institute for Health and Care Excellence (NICE) is the independent body responsible for driving improvement and excellence in the health and social care system. We develop guidance, standards and information on high-quality health and social care. We also advise on ways to promote healthy living and prevent ill health.

Our aim is to help practitioners deliver the best possible care and give people the most effective treatments, which are based on the most up-to-date evidence and provide value for money, in order to reduce inequalities and variation.

Our products and resources are produced for the NHS, local authorities, care providers, charities, and anyone who has a responsibility for commissioning or providing healthcare, public health or social care services.

To find out more about what we do, visit our website:www.nice.org.uk and follow us on Twitter: @NICEComms.