Title: Early Laser for Burn Scars (ELABS) - A prospective randomised, controlled trial (RCT) to study the effectiveness of the treatment of hypertrophic burn scars with Pulsed Dye Laser (PDL) and standard care compared to standard care alone
Funder: Department of Health and Social Care

Abstract: Research question Does the treatment of hypertrophic burn scars with pulsed dye laser during the early stages of scar formation improve both scar quality/appearance and quality of life (QoL) as assessed by the patient? Background Hypertrophic scars are abnormal scars that are red, raised and firm. These scars can occur following burn injury and, as survival rates from burns have improved significantly, an increasing number of burn survivors go on to live with expansive, life-changing hypertrophic scars. This residual scarring often needs further treatment to improve the outcome; functionally, aesthetically and psychologically. Aims and objectives The aim is to assess the effectiveness of treating hypertrophic burns scars with pulsed dye laser (PDL) at an early stage of scar formation. The objective is to improve QoL for the patient by improving both the appearance and quality of burn scarring, as well as reducing its psychological and psycho-social impact. The study will also evaluate both the cost-effectiveness and the patient-reported experience of the treatment. Methods This is a parallel-arm randomised, controlled trial to compare PDL and standard care against standard care alone. The difference is measured between baseline and 6 month follow-up. The recruits are within 3 months of healing from a burn injury; with wounds showing a defined potential for hypertrophic scarring. A total of 150 patients will be recruited in a multi-centre study at 7 burns units/centres across the UK. They are randomised in a 1:1 allocation to each arm. This detects the required effect size with 90% power. The treatment arm receive 3 PDL treatments at 6 week intervals in addition to standard care, whereas the control arm receives standard care alone. The primary outcome is the patient-rated part of the Patient and Observer Scar Scale (POSAS). Psychological and psycho-social impact is evaluated using the CARe burn scale (UWE, Bristol) and Quality Adjusted Life Years (QALY) is determined using the Short-Form Health Survey (SF-12). Blinded assessments include an objective measurement of the difference in scar redness at follow-up and observer-rated scar quality. Scar colour is measured objectively using a colorimeter. An economic analysis assesses the cost-effectiveness of this treatment. Qualitative interviews after follow-up identifies themes in the patient experience of the treatment process and its effectiveness in ameliorating the impact of scars. The adverse effect profile of the treatment is also mapped. Timelines for delivery This is a study of 36 months duration: 3 months trial set-up 21 months recruitment 6 months follow-up 6 months of data analysis and publication of reports Anticipated impact and dissemination Results from this study are disseminated to Healthcare Professionals through publications in journals and presentations at relevant burns and scar conferences nationally and internationally. The qualitative component is published within an open access journal such as BMJ (Open). It is anticipated that the research output will contribute towards a novel NICE guideline on the laser treatment of burn scars. It will produce a robust PDL treatment protocol that can be shared across the UK Burns Network, and possibly globally.

Lay abstract: Hypertrophic scars from burns injury affect about 120,000 people per year in the UK. These scars are red, thick and firm. They can be tight, itchy and painful with the potential to reduce the ability to carry out everyday activities; such as eating, sleeping or getting around. They can affect self-esteem and body image for the patient. All of this impacts on return to work and quality of life; and can cause depression and psychosocial problems. More people survive large burn injuries due to progress in both surgery and medicine. There are now more people that have to live with large, life-long scars. There is a definite clinical need to improve the treatment of these scars. Indeed the ambition statement of the national fundraising charity, Scar Free Foundation, is &quot;to achieve scar free healing within a generation&quot;. The aim of this study is to test if treatment with pulsed dye laser leads to an improved outcome for the patient, both in terms of their quality of life and in the appearance or quality of their scar. It is thought that, if this laser treatment is given at an early stage of scar healing, the degree of scarring will be reduced by stopping these scars forming. If laser treatment proves effective, not only will the outcome for the patient be improved but will mean a cost efficiency for the NHS. Additionally, this may lead to the development of new guidelines on laser treatment for scars globally. In April 2017, a patient group met to discuss the study and its design. The potential aim and benefit of this study was unanimously agreed. The group was keen to see quality of life as a measured outcome, in addition to scar appearance. Members from this group will continue to have input throughout the study This will be a gold-standard randomised, controlled trial; this means that patients will be randomised to each study group where one group does not receive laser. The study is undertaken by NHS staff in seven hospitals in England. A total of 150 patients with burn scars will be recruited. Half will receive standard care (care they would normally receive) for 6 months, while half will receive a course of three laser treatments, in addition to standard care. The participants will assess both their scar features and quality of life using simple questionnaires. Patient experience and cost-effectiveness will also be assessed and measured. The results will be presented at both UK and international meetings for the burns community; and published in relevant journals. It will be broadcast to charities such as Scar Free Foundation, Changing Faces, Dan s Fund and TalkHealth websites, which host online health hubs for burn scar patients.

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: INJURIES AND ACCIDENTS