Early laser treatment for burn scars
| ISRCTN | ISRCTN14392301 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14392301 |
| IRAS number | 283345 |
| Secondary identifying numbers | IRAS 283345, CPMS 49143 |
- Submission date
- 10/06/2021
- Registration date
- 14/06/2021
- Last edited
- 28/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English Summary
Background and study aims
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 the self-esteem and body image of 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 "to achieve scar-free healing within a generation".
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 from 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.
Who can participate?
Patients with burn scars aged 16 years or older
What does the study involve?
Half the participants 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.
What are the possible benefits and risks of participating?
Other burn patients in the future may benefit.
Laser treatment has a number of associated adverse effects but these are usually well prevented with judicious control of laser output parameters. The pain or discomfort of the laser treatment itself is minimised by the delivery of cold air during treatment and the option to take painkillers such as paracetamol prior to the treatment.
Where is the study run from?
Salisbury NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
May 2021 to January 2024
Who is funding the study?
Research for Patient Benefit Programme by the National Institute for Healthcare Research (NIHR) (UK)
Who is the main contact?
Dr Mark Brewin, mark.brewin@nhs.net
Contact information
Scientific
Salisbury Laser Clinic
Odstock Road
Salisbury
SP2 8BJ
United Kingdom
 ORCID ID |
0000-0002-4456-5885 |
|---|---|
| Phone | +44 (0)1722345520 |
| mark.brewin@nhs.net |
Study information
| Study design | Multicentre interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | ISRCTN14392301_PIS_v14_21May2021.pdf |
| Scientific title | 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 |
| Study acronym | EL4BS |
| Study hypothesis | Early Pulsed Dye Laser treatment of hypertrophic scars improves both scar outcome and psychological impact for the burn patient. |
| Ethics approval(s) | Approved 21/05/2021. Bristol Research Ethics Committee Centre (Ground Floor, Temple Quay House, Bristol BS1 6PN, UK; +44 (0)207 104 8029; centralbristol.rec@hra.nhs.uk), ref: 21/SW/0049 |
| Condition | Prevention/treatment of hypertrophic scars in burn patients |
| Intervention | 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 course of three Pulsed Dye Laser treatments at intervals of 6 weeks, in addition to standard care treatment. All follow-ups allow ± 1 week to allow for clinic administration. Allocation will be determined using a validated password-protected, web-based system hosted by the UKCRC registered Clinical Trials Unit (ExeCTU). Randomisation ratio is 1:1 control to treatment and is stratified by study site. The system uses random permuted blocks of varying size, within strata with possible block sizes of 2, 4 or 6. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Patient-rated Patient Observer Scar Assessment Scale (POSAS) at baseline and 6 months |
| Secondary outcome measures | 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. |
| Overall study start date | 21/05/2021 |
| Overall study end date | 10/01/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | 150 |
| Total final enrolment | 153 |
| Participant 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. |
| Participant exclusion criteria | 1. Unable to give informed consent. 2. Below 16 years of age. 3. Prone to keloid scarring. |
| Recruitment start date | 13/09/2021 |
| Recruitment end date | 30/06/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Odstock Road
Salisbury
SP2 8BJ
United Kingdom
Chelsea
London
SW10 9NH
United Kingdom
Mindelsohn Way
Edgbaston
Birmingham
B15 2GW
United Kingdom
Southmead Road
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
Broomfield
Chelmsford
CM1 7ET
United Kingdom
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Warrington Road
Prescot
L35 5DR
United Kingdom
Sponsor information
Hospital/treatment centre
Odstock Road
Salisbury
SP2 8BJ
England
United Kingdom
| Phone | +44 (0)1722 425027 |
|---|---|
| lbell1@nhs.net | |
| Website | https://www.salisbury.nhs.uk/ |
"ROR" |
https://ror.org/00ja2ye75 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Research for Patient Benefit Programme, RfPB
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Firstly, the trial protocol will be published in conjunction with the commencement of the trial in a journal such as BMJ Open. Results from this study will be disseminated to HCPs through both publications in the journal Burns and presentations at British Burns Association (BBA), European Burns Association (EBA) and/or International Society of Burn Injury (ISBI) annual meetings. The main publication will be submitted to Burns Open and this is costed in the budget. The qualitative component of the RCT is published within a high impact journal such as BMC(Open). |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository. RedCap at Exeter University. All investigators and trial site staff must comply with the requirements of the Data Protection Act 2018 with regards to the collection, storage, processing and disclosure of personal information and will uphold the Act’s core principles. Personal data will be stored on Consent Forms at sites and will remain at sites. Once consented into the study participants will be assigned a trial ID. The trial ID will be used to identify data collected on CRFs and stored on the CTU database. Access to the CTU database is password protected and limited to those individuals necessary for quality control, audit, and analysis. The sponsor will act as the data controller for this study and will archive identifiable information for up to 5 years after the study has finished. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version v14 | 21/05/2021 | 14/06/2021 | No | Yes |
| Protocol article | 18/01/2022 | 04/08/2022 | Yes | No | |
| Statistical Analysis Plan | version 1.6 | 08/06/2023 | No | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Plain English results | 28/11/2024 | No | Yes |
Additional files
Editorial Notes
28/11/2024: Plain English results uploaded.
10/05/2024: The following changes were made to the trial record:
1. The overall end date was changed from 31/05/2024 to 10/01/2024.
2. The total final enrolment was added.
3. The intention to publish date was changed from 01/06/2024 to 31/12/2024.
27/06/2023: The target number of participants was changed from 140 to 150.
08/06/2023: Statistical analysis plan uploaded.
22/05/2023: The following changes were made to the study record:
1. Sponsor details updated.
2. St Helens and Knowsley Teaching Hospitals NHS Trust was added to the study participating centres.
3. The recruitment end date was changed from 31/05/2023 to 30/06/2023.
4. The target number of participants was changed from 150 to 140.
04/08/2022: Publication reference added.
06/09/2021: The recruitment start date was changed from 01/09/2021 to 13/09/2021.
14/06/2021: The participant information sheet was uploaded as an additional file.
11/06/2021: Trial's existence confirmed by NHS HRA.
