弗拉米纳（Flaminal®）与磺胺嘧啶银乳膏（Flamazine®）治疗浅度烧伤的临床疗效、生活质量及成本效益：一项随机对照试验的研究方案
Clinical effectiveness, quality of life and cost-effectiveness of Flaminal® versus Flamazine® in the treatment of partial thickness burns: study protocol for a randomized controlled trial.
作者信息
Rashaan Zjir M, Krijnen Pieta, van den Akker-van Marle M Elske, van Baar Margriet E, Vloemans Adrianus F P, Dokter Jan, Tempelman Fenike R H, van der Vlies Cees H, Breederveld Roelf S
机构信息
Department of Surgery, Leiden University Medical Center, Postbus 9600, 2333 ZA, Leiden, The Netherlands.
Burn Centre, Red Cross Hospital Beverwijk, Postbus 1074, 1942 LE, Beverwijk, The Netherlands.
出版信息
Trials. 2016 Mar 5;17(1):122. doi: 10.1186/s13063-016-1240-5.
BACKGROUND
Partial thickness burns are painful, difficult to manage and can have a negative effect on quality of life through scarring, permanent disfigurement and loss of function. The aim of burn treatment in partial thickness burns is to save lives, stimulate wound healing by creating an optimumly moist wound environment, to have debriding and analgesic effects, protect the wound from infection and be convenient for the patient and caregivers. However, there is no consensus on the optimal treatment of partial thickness wounds. Flaminal® and Flamazine® are two standard treatment options that provide the above mentioned properties in burn treatment. Nevertheless, no randomized controlled study has yet compared these two common treatment modalities in partial thickness burns. Thus, the aim of this study is to evaluate the clinical effectiveness, quality of life and cost-effectiveness of Flaminal® versus Flamazine® in the treatment of partial thickness burns.
METHODS/DESIGN: In this two-arm open multi-center randomized controlled trial, 90 patients will be randomized between Flaminal® and Flamazine® and followed for 12 months. The study population will consist of competent or temporarily non-competent (because of sedation and/or intubation) patients, 18 years of age or older, with acute partial thickness burns and a total body surface area (TBSA) of less than 30 %. The main study outcome is time to complete re-epithelialization (greater than 95 %). Secondary outcome measures include need for grafting, wound colonization/infection, number of dressing changes, pain and anxiety, scar formation, health-related quality of life (HRQoL), and costs.
DISCUSSION
This study will contribute to the optimal treatment of patients with partial thickness burn wounds and will provide evidence on the (cost-)effectiveness and quality of life of Flaminal® versus Flamazine® in the treatment of partial thickness burns.
TRIAL REGISTRATION
Netherlands Trial Register NTR4486 , registered on 2 April 2014.
背景
浅度烧伤会引起疼痛，难以处理，并且可能通过瘢痕形成、永久性毁容和功能丧失对生活质量产生负面影响。浅度烧伤治疗的目的是挽救生命，通过营造最佳的湿润伤口环境来促进伤口愈合，具有清创和止痛作用，保护伤口免受感染，并且方便患者及其护理人员。然而，对于浅度伤口的最佳治疗方法尚无共识。Flaminal® 和 Flamazine® 是烧伤治疗中提供上述特性的两种标准治疗选择。尽管如此，尚无随机对照研究比较这两种浅度烧伤的常见治疗方式。因此，本研究的目的是评估 Flaminal® 与 Flamazine® 在浅度烧伤治疗中的临床疗效、生活质量和成本效益。
方法/设计：在这项双臂开放性多中心随机对照试验中，90 名患者将被随机分配至 Flaminal® 组和 Flamazine® 组，并随访 12 个月。研究人群将包括有行为能力或暂时无行为能力（由于镇静和/或插管）、年龄在 18 岁及以上、患有急性浅度烧伤且总体表面积（TBSA）小于 30% 的患者。主要研究结局是完成重新上皮化的时间（大于 95%）。次要结局指标包括植皮需求、伤口定植/感染、换药次数、疼痛和焦虑、瘢痕形成、健康相关生活质量（HRQoL）以及成本。
讨论
本研究将有助于浅度烧伤伤口患者的最佳治疗，并将提供关于 Flaminal® 与 Flamazine® 在浅度烧伤治疗中的（成本）效益和生活质量的证据。
试验注册
荷兰试验注册库 NTR4486，于 2014 年 4 月 2 日注册。
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