A Pilot Randomised Controlled Trial Evaluating a Regenerative Epithelial Suspension for Medium-Size Partial-Thickness Burns in Children: The BRACS Trial

IF 16.4 1区化学 Q1 CHEMISTRY, MULTIDISCIPLINARY

Accounts of Chemical Research Pub Date : 2023-03-22 DOI:10.3390/ebj4010012

Anjana Bairagi, Z. Tyack, R. Kimble, D. Vagenas, S. McPhail, B. Griffin

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引用次数: 0

Abstract

Background: There is little evidence regarding the efficacy of Regenerative Epidermal Suspension (RES™) management for paediatric partial-thickness burns. The Biobrane® RECELL® Autologous skin Cell suspension and Silver dressings (BRACS) Trial evaluated three dressings for the re-epithelialisation of partial thickness burns in children. Methods: Eligible children (age ≤ 16 years; ≥5% TBSA; ≤48 h of injury) were randomised to silver dressings, RES™/Biobrane® or Biobrane®. The measured outcomes were the time to re-epithelialisation (primary outcome), pain, itch, intervention fidelity, treatment satisfaction, health-related quality of life, health resource utilization and adverse effects. Results: The median time to re-epithelialization in days was no different for RES™/Biobrane® at 12 (IQR: 5.6–18.4; n = 7) and slower by two days for Biobrane® at 14 (IQR: 6.3–21.7; n = 7) when compared to silver dressings 12 (IQR: 3.7–20.3; n = 8). Reduced pain, fewer infections, no sepsis, no skin graft, and the lowest impact on health-related quality of life were reported in the RES™/Biobrane® group compared to other groups. Due to the COVID-19 pandemic, recruitment suspension resulted in a smaller cohort than expected and an underpowered study. Conclusions: The pilot trial findings should be interpreted cautiously; however, they indicate that a fully powered randomised controlled trial is warranted to substantiate the role of RES™ for medium to large paediatric partial-thickness burn management.

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一项评估再生上皮悬浮液治疗儿童中等大小部分厚度烧伤的随机对照试验:BRACS试验

背景:很少有证据表明再生表皮悬浮液(RES™)治疗小儿部分厚度烧伤的疗效。Biobrane®RECELL®自体皮肤细胞悬浮液和银敷料(BRACS)试验评估了三种敷料用于儿童部分厚度烧伤的再上皮化。方法:符合条件的儿童(年龄≤16岁;回溯≥5%;≤48小时的损伤)随机分配到银敷料，RES™/Biobrane®或Biobrane®。测量的结果包括再上皮化时间(主要结果)、疼痛、瘙痒、干预保真度、治疗满意度、健康相关生活质量、健康资源利用率和不良反应。结果:RES™/Biobrane®的中位再上皮化时间(d)在12 (IQR: 5.6-18.4;n = 7)，而Biobrane®在14 (IQR: 6.3-21.7;n = 7)，与银敷料12 (IQR: 3.7-20.3;据报道，与其他组相比，RES™/Biobrane®组疼痛减轻，感染减少，无败血症，无皮肤移植，对健康相关生活质量的影响最低。由于COVID-19大流行，招募暂停导致队列少于预期，研究力度不足。结论:对试点研究结果应谨慎解读;然而，他们指出，一项完全有力的随机对照试验有必要证实RES™在中度至大面积儿科部分厚度烧伤治疗中的作用。

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来源期刊

Accounts of Chemical Research 化学-化学综合

CiteScore

31.40

自引率

1.10%

发文量

312

审稿时长

2 months

期刊介绍： Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance. Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.