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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

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)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN34483199
Enrollment
88
Registered
2014-10-03
Start date
2014-10-01
Completion date
Unknown
Last updated
2018-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Children, Injuries and emergencies

Interventions

Patients are randomised to the following: 1. No Pressure Garment Therapy: No Pressure Garment Therapy, patient will receive other scar management therapies - silicone, moisturisation, massage 2. Press

Sponsors

University Hospital Birmingham NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who will be considered eligible for inclusion include: 1. Adults and children (age > 0 years) with burn injuries greater than 1 % Total Body Surface Area 2. Treated with split thickness skin grafts 3. Or conservatively managed burn wounds or donor sites which have taken > 2 weeks to heal 4. Evidence of hypertrophic scarring 5. Considered suitable for Scar Management Therapy; Target Gender: Male & Female

Exclusion criteria

Exclusion criteria: 1. Since Patient Reported Outcomes (PROs) identified from P1 may not be available in translated versions the pilot work will exclude participants who cannot speak, read and write in English 2. Significant psychiatric history 3. Deliberate self harm 4. Preexisting skin conditions affecting wound healing 5. History of keloid scarring 6. Known allergy to Pressure Garment Therapy (Lycra)

Design outcomes

Primary

MeasureTime frame
Can a large national RCT looking at PGT vs. no PGT be delivered successfully? Timepoint(s): 12 months

Secondary

MeasureTime frame
1. Health economics; Timepoint(s): 12 months 2. Pain and itch; Timepoint(s): 12 months 3. Patient reported outcomes; Timepoint(s): 12 months 4. Validated scar measurement outcomes; Timepoint(s): 12 months

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 6, 2026