ReCell® Spray-On Skin System for Treating Skin Loss, Scarring and Depigmentation after Burn Injury: A NICE Medical Technology Guidance
The gold standard treatment for deep burns is an autologous skin graft; in larger burns this may be meshed to increase the area covered. However, long-term aesthetic and functional outcomes of graft scars may be poor. ReCell® is a medical device that processes skin samples in the operating theatre into a cell suspension to be sprayed or dripped onto a wound. It is claimed to improve healing and scar appearance. This device was evaluated by the National Institute for Health and Care Excellence (NICE) Medical Technologies Evaluation Programme. Two groups were defined: ReCell compared to conventional dressings in shallower burns, and meshed grafts plus ReCell compared to meshed grafts alone in larger deeper burns. The manufacturer’s clinical evidence submission included three papers and eight conference abstracts. The External Assessment Centre (EAC) excluded two of these and added seven abstracts. In general, the evidence did not fit the defined groups, but suggested that ReCell was clinically comparable to skin grafts for partial thickness burns; however, ReCell is not used in this way in the UK. The manufacturer submitted an economic model in which ReCell treatment of partial thickness burns reduced the requirement for later skin grafts. This indicated that ReCell alone was cost saving in comparison to conventional dressings. The EAC indicated that this model was clinically inappropriate, but data were not available to populate a new model. NICE Medical Technologies Guidance 21 recommended that additional research was needed to address the uncertainties regarding the potential benefits of ReCell.
The authors thank Prof. Ceri Phillips, Kateryna Onishenko (Swansea Centre for Health Economics, Swansea University) and Kathleen Withers (Cedar) for their contributions to the External Assessment Centre assessment report and additional survey work. The authors also thank Dr. Judith White for help with the formatting and editing of the manuscript. This article has been reviewed by the National Institute for Health and Care Excellence and has not been externally peer reviewed by Applied Health Economics and Health Policy.
SCP and GCR evaluated both the clinical and economic evidence on which this manuscript is based. SCP conducted the survey of clinical opinion. GCR reviewed the full External Assessment Centre report and this article, and can act as a guarantor for the overall content.
Compliance with Ethical Standards
Cedar is a collaboration between Cardiff and Vale University Health Board and Cardiff University. Cedar is funded by NICE to act as an EAC for the Medical Technologies Evaluation Programme.
Conflict of interest
Cedar is funded by the National Institute for Health and Care Excellence Medical Technologies Evaluation Programme to act as an External Assessment Centre. Susan C. Peirce is employed by Cardiff University and Grace Carolan-Rees is a UK National Health Service employee; the National Health Service has a financial interest in the guidance on which this project is based.
This article does not contain any studies with human participants or animals performed by any of the authors.
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