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Early laser treatment for burn scars

Early Laser for Burn Scars (EL4BS) - A multi-centre randomised, controlled trial of both the effectiveness and cost-effectiveness of the treatment of hypertrophic burn scars with Pulsed Dye Laser and standard care compared to standard care alone

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14392301
Enrollment
150
Registered
2021-06-14
Start date
2021-09-13
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Prevention/treatment of hypertrophic scars in burn patients Skin and Connective Tissue Diseases

Interventions

Both arms of the trial will be given standard care. The choice of standard care for this trial includes
moisturisation and massage up to 2 - 3 times per day (as directed by the Health Care Professional
where maintenance of hydration is required) ± silicone gel treatment ± pressure garments, dependent upon scar maturation. The control arm receives standard care only. The treatment arm receives a cou

Sponsors

Salisbury NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 110 Years

Inclusion criteria

Inclusion criteria: 1. NHS patients, with burn injuries >1% Total Body Surface Area (TBSA), are eligible if they have had skin grafts to, or have conservatively managed, burn wounds or donor sites that: 1.1. Have delayed healing of greater than 2 weeks. 1.2. Have potential for Hypertrophic Scarring (HS). 1.3 Are suitable for scar management therapy. 2. The scar is within 3 months of healing, where healing time-point is defined during wound management. The combination of excessive redness with increased thickness and/or hardness provides clear indication of HS. 3. Children aged 16 - 18 are able to participate with appropriate consent.

Exclusion criteria

Exclusion criteria: 1. Unable to give informed consent. 2. Below 16 years of age. 3. Prone to keloid scarring.

Design outcomes

Primary

MeasureTime frame
Patient-rated Patient Observer Scar Assessment Scale (POSAS) at baseline and 6 months

Secondary

MeasureTime frame
Measured at baseline and 6 months 1. QoL: Bristol CARe scale. 2. Quality Adjusted Life Years (QALY): SF-12 Health Survey. 3. Scar colour: Colorimeter measurements of redness (DSMIII ColorMeter, Cortex Technology, Denmark). Objective measurement is compared to POSAS colour score. 4. MCID - A 7-point scale question evaluates improvement at 6 month follow-up, as judged by the participant.

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 13, 2026