The study has two overlapping Phases, P1 and P2:
The overarching aim of the project is to define the design and assess the feasibility of a full-scale randomised controlled trial of the effectiveness and cost-effectiveness of pressure garments. The aim is addressed through two interlinked Phases (P1 and P2) of feasibility work.
P1: Qualitative Research Preliminary Surveys: Web-based survey and telephone interviews with burns consultants and occupational therapists designed to explore initial opinions on willingness to randomise and identify perceived barriers to participation in a Randomised Controlled Trial. In addition, in-depth interviews and focus groups with adults, children, carers and clinicians will be used to explore patient centred outcomes and willingness to randomise. Resource use and health economic measures will also be assessed.
P2 Randomised Controlled Trial:
A feasibility and open pilot two-arm Randomised Controlled Trial (RCT) comparing PGT with no-PGT; the trial will assess willingness to randomise and pilot trial processes, outcomes and health economic assessments across 7 UK centres.
Adults, young persons and children can be recruited and screened for the randomised controlled trial when their burns are 90% healed, and can be randomised and commence intervention when the burns have fully healed.
Qualitative Research Pilot Trial Process Evaluation:
Participants and parents/carers of participants who are recruited to the pilot trial OR declined to participate in the trial; non-participant viewpoints, participant viewpoints, trial site staff viewpoints will be included.