{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,16]],"date-time":"2026-06-16T00:04:36Z","timestamp":1781568276067,"version":"3.54.5"},"reference-count":75,"publisher":"National Institute for Health and Care Research","license":[{"start":{"date-parts":[[2022,1,18]],"date-time":"2022-01-18T00:00:00Z","timestamp":1642464000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000272","name":"National Institute for Health Research","doi-asserted-by":"publisher","award":["ResearchforPatientBenefit-NIHR201080"],"award-info":[{"award-number":["ResearchforPatientBenefit-NIHR201080"]}],"id":[{"id":"10.13039\/501100000272","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["openresearch.nihr.ac.uk"],"crossmark-restriction":false},"short-container-title":["NIHR Open Res"],"abstract":"This paper outlines the protocol for a study that is being carried out at multiple centres across the UK in the next three years. It is a Research for Patient Benefit (RfPB) study funded by the National Institute for Healthcare Research (NIHR). The aim is to assess the effectiveness of treating hypertrophic burns scars with pulsed dye laser (PDL) at an early stage of scar formation.\u00a0 The objective is to improve Quality of Life for the patient by improving both the appearance and quality of burn scarring, as well as reducing its psychological impact.<\/ns4:p>\n This is a parallel-arm randomised, controlled trial to compare PDL and standard care against standard care alone.\u00a0 The difference is measured between baseline and six-month follow-up.\u00a0Recruits are within three months of healing from a burn injury; with wounds showing a defined potential for hypertrophic scarring.\u00a0A total of 120 patients are recruited in a multi-centre study; with randomisation in a 1:1 allocation to each arm.\u00a0 The treatment arm receives 3 PDL treatments at six-week intervals in addition to standard care, whereas the control arm receives standard care alone.\u00a0 The primary outcome is the patient-rated part of the Patient and Observer Scar Scale (POSAS).\u00a0 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). The study evaluates both the cost-effectiveness through an economic analysis and the patient-reported experience of the treatment by phone interviews.<\/ns4:p>\n \n Trial registration:<\/ns4:bold>\n ISRCTN14392301<\/ns4:ext-link>\n (registered on 14\n th<\/ns4:sup>\n June 2021)\n <\/ns4:p>\n \n Contact for Public & Scientific Queries:<\/ns4:bold>\n Mark Brewin,\n sft.elabs@nhs.net<\/ns4:ext-link>\n \u00a0<\/ns4:bold>\n <\/ns4:p>\n \n \n Public Title:<\/ns4:bold>\n Early Laser for Burn Scars (ELABS): a trial of the effectiveness and cost of the treatment of hypertrophic burn scars with laser\n <\/ns4:ext-link>\n <\/ns4:p>\n \n \n Countries of Recruitment:<\/ns4:bold>\n England & Scotland\n <\/ns4:ext-link>\n <\/ns4:p>\n \n \n Protocol Version:<\/ns4:bold>\n v11, October 2021\n <\/ns4:ext-link>\n <\/ns4:p>","DOI":"10.3310\/nihropenres.13234.1","type":"journal-article","created":{"date-parts":[[2022,1,18]],"date-time":"2022-01-18T10:26:42Z","timestamp":1642501602000},"page":"1","update-policy":"https:\/\/doi.org\/10.3310\/nihropenres.crossmark-policy","source":"Crossref","is-referenced-by-count":6,"title":["Early Laser for Burn Scars (ELABS): protocol for 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"],"prefix":"10.3310","volume":"2","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4456-5885","authenticated-orcid":false,"given":"Mark","family":"Brewin","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sharon","family":"Docherty","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2037-4002","authenticated-orcid":false,"given":"Vanessa","family":"Heaslip","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katie","family":"Breheny","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathon","family":"Pleat","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shelley","family":"Rhodes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"6221","published-online":{"date-parts":[[2022,1,18]]},"reference":[{"key":"ref-1","doi-asserted-by":"publisher","first-page":"1648-1653","DOI":"10.1007\/s00134-005-2819-6","article-title":"Outcome and changes over time in survival following severe burns from 1985 to 2004.","volume":"31","author":"N Brusselaers","year":"2005","journal-title":"Intensive Care Med."},{"key":"ref-2","doi-asserted-by":"crossref","first-page":"895-8","DOI":"10.1097\/00005373-198310000-00009","article-title":"Hypertrophic burn scars: analysis of variables.","volume":"23","author":"E Deitch","year":"1983","journal-title":"J Trauma."},{"key":"ref-3","doi-asserted-by":"publisher","first-page":"19","DOI":"10.1186\/s41038-017-0084-x","article-title":"Identification of factors predicting scar outcome after burn injury in children: a prospective case-control study.","volume":"5","author":"H Wallace","year":"2017","journal-title":"Burns Trauma."},{"key":"ref-4","doi-asserted-by":"publisher","first-page":"547-552","DOI":"10.1097\/00000658-198905000-00006","article-title":"A comparison of conservative versus early excision. 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Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/2-1\/v1\/xml","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/2-1\/v1\/pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/2-1\/v1\/iparadigms","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,15]],"date-time":"2023-08-15T11:39:16Z","timestamp":1692099556000},"score":1,"resource":{"primary":{"URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/2-1\/v1"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,1,18]]},"references-count":75,"URL":"https:\/\/doi.org\/10.3310\/nihropenres.13234.1","relation":{"has-review":[{"id-type":"doi","id":"10.3310\/nihropenres.14350.r28461","asserted-by":"subject"},{"id-type":"doi","id":"10.3310\/nihropenres.14350.r28465","asserted-by":"subject"},{"id-type":"doi","id":"10.3310\/nihropenres.14350.r28461","asserted-by":"object"},{"id-type":"doi","id":"10.3310\/nihropenres.14350.r28465","asserted-by":"object"}]},"ISSN":["2633-4402"],"issn-type":[{"value":"2633-4402","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,1,18]]},"assertion":[{"value":"Indexed","URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/2-1\/v1#article-reports","order":0,"name":"referee-status","label":"Referee status","group":{"name":"current-referee-status","label":"Current Referee Status"}},{"value":"10.3310\/nihropenres.14350.r28461, Paul P. M. van Zuijlen, Burn Centre, Red Cross Hospital, Beverwijk, 09 Feb 2022, version 1, indexed","URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/2-1\/v1#referee-response-28461","order":0,"name":"referee-response-28461","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"Mark Brewin<\/b>; \nPosted: 23 Jan 2023<\/i>; Thanks Paul for your comments on our trial. As you have surmised, the 6 month follow-up is a compromise due to several reasons. Firstly, the funding stream (NIHR RfPB) demands are for a 3 year trial period and this should include study set up as well as data analysis and write-up. This reduces the time period by a minimum of 6 months. In order to get sufficient recruits to power the study, we need a number of sites and a lengthy recruitment period (in this case 21 months). This prevents us from a lengthier follow-up period. In addition, a 6 month study period keeps the study attractive to potential recruits as some people are wary of committing to a longer follow-up than this. Finally attrition is a consideration as people will be lost to follow-up for longer follow-up periods. There is a plan afoot to further follow-up the patients to collect Patient POSAS scores and this may form an interesting PhD or MPhil project. The potential for follow-up was written into the study consent form so we can capture this data with the consent of the patient. This "extra" paper will be of huge interest.","URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/2-1\/v1#referee-comment-3228","order":1,"name":"referee-comment-3228","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.3310\/nihropenres.14350.r28465, Mamta Shah, Burns and Plastic Surgery Department, Royal Manchester Children's Hospital, Manchester, 28 Feb 2022, version 1, indexed","URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/2-1\/v1#referee-response-28465","order":2,"name":"referee-response-28465","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"Mark Brewin<\/b>; \nPosted: 23 Jan 2023<\/i>; Thanks Mamta for your well informed comments. We shall endeavour to answer each comment in turn. It is a valid point that you make in asking for the data of how many patients in the PPI group has PDL treatment. This data is valuable and may have been lost in one of the many edits of our documents. For the records, of the 18 attendees, there were 9 burn injury patients, all of whom had had laser treatment, 6 had received laser treatment for non-burns and 1 who has had treatment for a surgical scar. As for the within 3 months of healing regimen, we have tried to make it as early as possible while considering that newly healed scale may still be fragile. Any adverse events or effects of laser treatment this soon will be picked up in the adverse event data within the study protocol. It is understood that donor sites are different to burn injury sites and data is captured as to whether the study scar is burn site or donor site. To date, no donor sites have been chosen (at recruit 93 of 150 required). The laser settings were chosen after an extensive literature search (Brewin \net al<\/i> 2014), a service evaluation conducted at Salisbury between 2014-2018 and an agreement between principal investigators at all sites included in the trial. It is accepted that some burn scar may be of different colour and thickness but it was reckoned that as the laser treatment is starting early, the scars should be relatively thin (though admittedly somewhat thickened) and red in nature. This would indicate the need to use a superficial 0.5 ms pulse. Experience at our centre has shown best results when an outcome of strong purpura is achieved, thus the relatively aggressive energy fluences. We agree that the 6 month follow up may be insufficient to make long term assumptions and we have answered this point in Reviewer 1\u2019s comments here. A plan is in writing to follow up these patients further and consent for this is given by the recruit at the enrolment stage of this study. It was always our intention to follow up long term but this was not possible within the NIHR Research for Patient Benefit grant time-frame.","URL":"https:\/\/openresearch.nihr.ac.uk\/articles\/2-1\/v1#referee-comment-3229","order":3,"name":"referee-comment-3229","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"This study is funded by the National Institute of Healthcare Research (NIHR) Research for Patient Benefit Programme (RfPB) - NIHR201080. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.","order":4,"name":"grant-information","label":"Grant Information"},{"value":"This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.","order":0,"name":"copyright-info","label":"Copyright"}]}}