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ReCell RCT

Lay summary

This trial was to see whether ReCell cell spray could improve outcomes in patients with severe burns. The gold standard treatment for large and deep burns is to take a skin graft from an undamaged area of the patient and mesh it so that it can stretch to cover a larger area. This is applied to a cleaned burn wound, where it gradually becomes attached to the surface, with additional cell repair in the mesh ‘holes’. Doing this means creating new wounds on the patient, which cause additional pain and take time to heal. The ReCell device allows a small sample of a patient’s skin to be processed into a suspension of skin cells. This can be sprayed onto a wound with the intention of aiding healing. The purpose of the study was to see if adding ReCell spray to a smaller skin graft than usual, using mesh that is wider than usual, would heal as well as a standard meshed graft. That is, does adding ReCell spray mean that less undamaged skin needs to be taken in order to heal the burn?

The trial was a randomised controlled feasibility trial in patients with a burn that needed a meshed graft. Participants were allocated to have the standard meshed graft, or a smaller graft with wider mesh plus the ReCell spray. As a feasibility study, we were testing to see whether a study like this could be done in the UK, and to see whether ReCell had sufficient benefits that would outweigh the additional cost of the technology. In the UK, severe burns are relatively rare and are only treated at a small number of specialist burns centres. The trial was therefore designed to run in 3 centres to obtain enough participants.

Cedar’s role

Following guidance MTG21, NICE commissioned Cedar to design and run a trial to see whether ReCell cell spray could improve outcomes in patients with severe burns. Cedar designed the study in collaboration with a number of clinical specialists and with input from the manufacturer. Cedar would also manage the study, monitor the sites, and analyse the data.

The study was approved by Research Ethics Committee in July 2017 and was adopted onto the NIHR and Welsh clinical research portfolios. However, in September 2018 the manufacturer withdrew the product from sale in Europe and also withdrew funding from the study. This was just prior to the start of recruitment and so no data was collected.

Study details

  • Full title: A feasibility study to investigate the benefits and costs of ReCell with meshed autografts versus autografts alone in burns
  • Study design: Multi-centre randomised controlled feasibility trial
  • Chief Investigator: Dr Susan Peirce
  • Sponsor: Cardiff University
  • Clinical Lead: Prof Naiem Moiemen
  • Funding: Unrestricted grant from Avita Medical
  • Ethical approval: Wales REC 4, ref: 17/WA/0173