PEGASUS

PEGASUS-LogoThe most common complication following burns is hypertrophic (abnormal) scarring.  These develop within one to three months following burn injury. Age, ethnic group, genetic factors and burn type and depth have been implicated to affect burn healing.  The main documented non-surgical approach to their prevention and treatment is pressure garment therapy (PGT). PGT involves the wearing of tight, Lycra-based garments, in direct contact with skin from when the burn wounds have healed until scarring has matured. Although PGT is now the standard of care, the evidence of the benefits of PGT in the literature is weak and considering the cost to the patients in terms of discomfort and sometimes complications, a feasibility study of PGT is now required.  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.

Design

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.

Aim of Study

The overarching aim of the project is to define the design and assess the feasibility of a full-scale open trial of the effectiveness and cost-effectiveness of pressure garments.  The aim is addressed through two interlinked Phases (P1 and P2) of feasibility work.

Setting

Seven burns centres across England and Wales (RCT)

Target population

Adults and Children with burn injuries > 1 % Total Body Surface Area

  • Those treated with split thickness skin grafts or conservatively managed burn wounds or donor sites which have taken > 2 weeks to heal
  • Those with potential for hypertrophic scarring
  • Those considered suitable for Scar Management Therapy

Intervention

Patients will be randomly allocated to either:

  • Scar Management Therapy with Pressure Garments or;
  • Scar Management Therapy without Pressure Garments

 

This project is funded by the National Health Research's Health Technology Assessment Programme (project number 12/145/04).