Randomised controlled trial of pulsed dye laser treatment and standard care versus standard care alone for the treatment of hypertrophic burn scars

Abstract

Background Hypertrophic burn scarring (HBS) is described as “the greatest unmet challenge after burn injury”. This ELABS trial hypothesised that early pulsed dye laser (PDL) treatment of HBS improves both scar quality and quality of life (QoL). Methods A parallel arm randomised controlled trial to assess the effectiveness and cost-effectiveness of PDL was undertaken at seven centres in the UK. Patients were eligible if their burn injury was within three months of wound healing, and ineligible either with history of keloid scarring or aged <16 years. A total of 153 (77 Male, 76 Female) participants were recruited between Nov 17, 2021, and Jun 30, 2023, and were randomised using software in a 1:1 ratio stratified by study centre; 138 (69 each arm) were included in the final complete-case analysis. Both study arms received standard care, and the intervention arm received three PDL treatments. The primary outcome was patient-rated scar quality (POSAS) at six months. The trial was registered with International Standard Randomised Controlled Trial Number registry (ISRCTN14392301). Findings Early PDL showed a statistically significant improvement in patient-rated scar quality (p=0·041) and the secondary outcome, participant’s perception of change in scar quality (p=0·01) at six months. There were no statistically significant differences for Quality-of-Life, observer-rated POSAS scar quality and colour measurement. Early PDL is not cost-effective at 6 months follow-up for the willingness-to-pay threshold of £20,000 per Quality-Adjusted-Life-Year (QALY). There were no unexpected adverse events related to the intervention. Interpretation Early PDL treatment of HBS is safe and shows improvement for patient-rated scar quality but not QoL at six months. As scar maturation is prolonged and dynamic, longer-term follow-up of upwards of two years is required both to understand the eventual clinical effect on scar outcome and to make any definitive conclusion concerning cost-effectiveness.