Title: A feasibility study and open pilot two-arm randomised controlled trial comparing Pressure Garment Therapy with no Pressure Garment Therapy for the prevention of abnormal scarring after burn injury (PEGASUS)
Funder: Department of Health (England)

Abstract: DESIGN: The study has two overlapping phases P1 and P2.P1: Survey of current practice with PGT across UK burns centres to inform patient numbers current use of PGT and other scar treatments. Web-based survey and telephone interviews with burns consultants and occupational therapists to gauge initial opinions on willingness to randomise and identify perceived barriers to participate in an RCT. Undertaking this phase will also allow identification of patient centred outcomes and willingness to randomise through in-depth interviews and focus groups with adults children carers and clinicians.P2: An open pilot two-arm RCT comparing PGT with no-PGT will assess willingness to randomise and pilot trial processes outcomes and health economic assessments across 6 sites. Process evaluation will include interviews with participants non-participants and clinicians to provide understanding of perspectives on patient recruitment and consent; accrual; integration of trial processes in clinical contexts; acceptability of allocation to treatment; compliance blinding and measurement of outcomes.SETTING: Specialist burns units treating adults/children (Birmingham Bristol (adults only) Chelmsford East Grinstead Manchester Swansea).TARGET POPULATION: P1: burns specialists occupational therapists and nursing staff from Burns Units; adults young people and carers of children undergoing or having completed PGT for the management of their burns scars.P2: adults and children (age>0y) considered for PGT following burn injuries treated with split thickness skin grafts or conservatively managed burn wounds or donor sites which have taken >2wks to heal. Burn areas must have evidence of hypertrophic scarring and be greater than 1% Total Body Surface Area. Patients with a significant psychiatric history or deliberate self-harm pre-existing skin conditions affecting wound healing history of keloid scarring or prior allergy to PGT (Lycra) will be excluded. At the stage when 90% wound healing has occurred (visual assessment by therapist) patients will be consented screened for inclusion/exclusion criteria and randomized to PGT or no-PGT.HEALTH TECHNOLOGIES BEING ASSESSED: PGT. Both commercially manufactured and NHS manufactured garments (e.g. vests trunks leggings) will be used according to the policy of the NHS trusts involved. Assessment of scar will use a cutometer to objectively measure skin elasticity in limbs.MEASUREMENT OF OUTCOMES: Patient centred outcomes for inclusion in the RCT will be identified from the literature8 and in P1. The choice of primary outcome will be informed through PI in particular P1c. The outcomes may include a validated measure of scar appearance (selected from existing tools such as the Vancouver Scar Scale or Patient Observer Scar Assessment Scale); objective measurements of scar firmness/pliability colour and thickness (assessed using cutometer); pain itch and sensation; active and passive range of movement assessed by goniometry; pruritis; psychological evaluations; return to work or adverse events (ulceration/wound breakdown contractures/significant loss of joint range of movement interference with growth intra-lesion steroid injection for aggressive hypertrophic scars surgical intervention/scar revision). The ability to assess compliance with PGT by patient diary will be assessed. Scars will be recorded by photograph at each visit. Outcomes in the pilot will be assessed at weeks 4 12 24 52. Ability to randomise and recruitment rates will be assessed from detailed screening logs in each centre. The feasibility and acceptability of measuring QoL using the EQ-5D-5L and ICECAP-A for adults and the CHU-9D for children will be assessed during the trial. We will also explore the feasibility of valuing broader sets of outcomes (including process attributes likely to be relevant to patients wearing pressure garments) through willingness to pay (WTP). WTP questions will be administered face to face to participants in both arms and we will explore: the acceptability of the method; difficulties encountered and the success of various options to enhance understanding and engagement. The economic evaluation will adopt an NHS perspective and include direct treatment costs consultation and follow-up costs using patient-held diaries and unit records.SAMPLE SIZE: P1: All UK burns units their consultants and occupational therapists will be invited to participate in the web-based survey. Participants will be identified from the national burns networks in England and Wales. A maximum variation sample (n=30) of adult patients parents and carers will take part in in-depth interviews. Children aged from 9-16 yrs will take part in 3 age-specific focus groups. Telephone interviews (n=20) and focus groups (n=2) will be conducted with clinical staff. P2: Each of the 6 centres will aim to recruit 8 adult patients and 5 centres will aim to recruit 8 children (n=88) allowing the recruitment rate to be estimated with a 95% confidence interval maximum width of 20%. The process evaluation will include interviews with patients and / or carers allocated to PGT (n=12) and no-PGT (n=12) and clinical staff (n=20) (burns consultants therapists nurses).PROJECT TIMETABLE: The 2 phases of the project will overlap enabling completion within 30 months. The RCT will commence with a basic set of outcome assessments the final set being finalised before the first recruit reaches the 52 week assessment point. Timelines are: P1: M1 to M12; P2: Trial set-up M1-M3; recruitment M4-M16; follow-up M16-M28; analysis and reporting M28-M30. Each site will have 12 months to recruit 8 adult and 8 child patients - failure to achieve this would be indicative of a larger trial being unfeasible.EXPERTISE IN TEAM: The team includes relevant clinicians and therapists involved in the provision of PGT care to burns patients; an experienced CTU with trial management statistics IT and QA expertise; expert qualitative outcomes and health economic researchers and a service user. The team includes those experienced in both care and research with adults and children. The wider team includes clinicians and therapists from all 6 sites.


Research activity codes: 6.3 MEDICAL DEVICES;7.3 MANAGEMENT AND DECISION MAKING
Health categories: INJURIES AND ACCIDENTS