The UK’s National Institute for Health and Care Excellence (NICE) has opened its consultation on draft guidance for a ‘spray-on skin’ device that aims to help improve the healing of acute burns.
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.
NICE Medical Technologies Advisory Committee’s preliminary view is that the ReCell Spray-On Skin 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. The Committee therefore provisionally 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.
The ReCell Spray-On Skin 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 earlier discharge, lower likelihood of scarring and better matching of skin colour, and a reduction in skin graft donor site size and depth. 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.
Professor Carole Longson, Director of the NICE Centre for Health Technology Evaluation, said: “Around twelve thousand people a year have burns wounds which require hospital admission, which sometimes involve long hospital stays. The NICE Medical Technologies Advisory Committee thought that the ReCell Spray-On Skin system shows potential to improve healing in acute burns. However as it does not currently have enough evidence to support the case for adoption, it has provisionally recommended that further research is carried out. The research should include how long it takes for the burn wound to become 95% healed, length of hospital stay, how much scarring results and how the well the burned area functions, compared against standard care. If and when final medical technologies guidance is published in which there are recommendations for further research, NICE will be able to actively facilitate the generation of further evidence together, in collaboration with the technology sponsor and with clinical and academic partners.
“It’s essential to note that this draft recommendation for further research doesn’t mean that this promising device should not be used, as it’s important that more data can be generated to help inform further considerations on its clinical utility. NICE proposes reviewing its guidance when new and substantive evidence becomes available. We look forward to receiving comments on our provisional recommendations from health professionals, industry and patient groups as part of this consultation, to help inform the development of the guidance.”
More information on the medical technology draft guidance consultation for the ReCell Spray-On Skin system is available here. The consultation closes on 19 May 2014.