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早期激光治疗烧伤瘢痕(ELABS):一项多中心随机对照试验方案,旨在比较脉冲染料激光联合标准护理与单纯标准护理治疗增生性烧伤瘢痕的有效性和成本效益[版本1;同行评审:2人批准]

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 [version 1; peer review: 2 approved].

作者信息

Brewin Mark, Docherty Sharon, Heaslip Vanessa, Breheny Katie, Pleat Jonathon, Rhodes Shelley, van Zuijlen Paul P M, Shah Mamta

机构信息

Burns & Plastics, Salisbury NHS Foundation Trust, Salisbury, Wiltshire, SP2 8BJ, UK.

University of Bournemouth, Poole, Dorset, BH12 5BB, UK.

出版信息

NIHR Open Res. 2022 Jan 18;2:1. doi: 10.3310/nihropenres.13234.1.


DOI:10.3310/nihropenres.13234.1
PMID:35392303
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7612584/
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. 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. 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 six-month follow-up. Recruits are within three months of healing from a burn injury; with wounds showing a defined potential for hypertrophic scarring. A total of 120 patients are recruited in a multi-centre study; with randomisation in a 1:1 allocation to each arm. The treatment arm receives 3 PDL treatments at six-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). The study evaluates both the cost-effectiveness through an economic analysis and the patient-reported experience of the treatment by phone interviews.

摘要

本文概述了一项未来三年将在英国多个中心开展的研究方案。这是一项由英国国家卫生研究院(NIHR)资助的患者受益研究(RfPB)。其目的是评估在瘢痕形成早期使用脉冲染料激光(PDL)治疗肥厚性烧伤瘢痕的有效性。目标是通过改善烧伤瘢痕的外观和质量,以及减轻其心理影响,来提高患者的生活质量。这是一项平行组随机对照试验,将PDL联合标准护理与单纯标准护理进行比较。测量基线与六个月随访之间的差异。招募对象为烧伤愈合后三个月内的患者;伤口显示有明确的肥厚性瘢痕形成潜力。在一项多中心研究中总共招募120名患者;随机以1:1的比例分配到每组。治疗组除接受标准护理外,每隔六周接受3次PDL治疗,而对照组仅接受标准护理。主要结局是患者和观察者瘢痕量表(POSAS)中患者自评部分。使用CARe烧伤量表(英国布里斯托尔西英格兰大学)评估心理和心理社会影响,并使用简短健康调查问卷(SF-12)确定质量调整生命年(QALY)。该研究通过经济分析评估成本效益,并通过电话访谈评估患者报告的治疗体验。

相似文献

[1]
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 [version 1; peer review: 2 approved].

NIHR Open Res. 2022-1-18

[2]
Early Laser for Burn Scars (ELABS) - Randomised controlled trial of pulsed dye laser treatment and standard care versus standard care alone for the treatment of hypertrophic burn scars.

Burns. 2025-6

[3]
[Effect of pulsed dye laser in combination with ultra-pulsed fractional carbon dioxide laser in treating pediatric burn scars at early stage].

Zhonghua Shao Shang Za Zhi. 2020-5-20

[4]
The efficacy, satisfaction, and safety of carbon dioxide (CO2) fractional laser in combination with pulsed dye laser (PDL) versus each one alone in the treatment of hypertrophic burn scars: a single-blinded randomized controlled trial.

Lasers Med Sci. 2024-2-20

[5]
The use of carbon dioxide and intense pulsed light laser for the treatment of hypertrophic burn scars: A case series.

Scars Burn Heal. 2023-11-15

[6]
Evaluation of the efficacy, safety, and satisfaction rate of topical latanoprost in patients with hypopigmented burn scars treated with fractional CO2 laser: a double-blind randomized controlled clinical trial.

Lasers Med Sci. 2025-1-9

[7]
Prevention or treatment of hypertrophic burn scarring: a review of when and how to treat with the pulsed dye laser.

Burns. 2014-8

[8]
Pressure-garment therapy for preventing hypertrophic scarring after burn injury.

Cochrane Database Syst Rev. 2024-1-8

[9]
Evaluating the effectiveness and safety of pulsed dye laser alone, the combination of pulsed dye laser and botulinum toxin type A, and the combination of pulsed dye laser and triamcinolone injection in the treatment of hypertrophic and keloid scars: a three-arm randomized controlled clinical trial.

Lasers Med Sci. 2025-2-15

[10]
Analysis of the Utility of CO2 and Pulse-Dye Lasers Together and Separately in the Treatment of Hypertrophic Burn Scars.

Ann Plast Surg. 2022-8-1

引用本文的文献

[1]
Very Early Pulsed Dye Laser Intervention for Optimal Cosmetic Outcome in Post-Thyroidectomy Scars.

Clin Cosmet Investig Dermatol. 2024-4-17

[2]
[Thinking and prospect of scar reconstruction].

Zhonghua Shao Shang Yu Chuang Mian Xiu Fu Za Zhi. 2023-9-20

本文引用的文献

[1]
Laser management of hypertrophic burn scars: a comprehensive review.

Burns Trauma. 2020-1-16

[2]
Early laser intervention to reduce scar formation in wound healing by primary intention: A systematic review.

J Plast Reconstr Aesthet Surg. 2019-10-11

[3]
Factors Associated with Attrition of Adult Participants in a Longitudinal Database: A National Institute on Disability, Independent Living, and Rehabilitation Research Burn Model System Study.

J Burn Care Res. 2020-2-19

[4]
Carbon dioxide laser treatment in burn-related scarring: A prospective randomised controlled trial.

J Plast Reconstr Aesthet Surg. 2019-2-10

[5]
The Development and Validation of the CARe Burn Scale-Adult Form: A Patient-Reported Outcome Measure (PROM) to Assess Quality of Life for Adults Living with a Burn Injury.

J Burn Care Res. 2019-4-26

[6]
Patient-reported scar quality of adults after burn injuries: A five-year multicenter follow-up study.

Wound Repair Regen. 2019-3-6

[7]
Partial thickness wound: Does mechanism of injury influence healing?

Burns. 2019-2-8

[8]
The lived experience and quality of life with burn scarring-The results from a large-scale online survey.

Burns. 2018-11

[9]
Pressure garment to prevent abnormal scarring after burn injury in adults and children: the PEGASUS feasibility RCT and mixed-methods study.

Health Technol Assess. 2018-6

[10]
Laser Therapy for Pediatric Burn Scars: Focusing on a Combined Treatment Approach.

J Burn Care Res. 2018-4-20

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