Open label randomized controlled trial of the efficacy and safety of NexoBrid compared to standard of care in children with burns

IF 3.2 3区医学 Q2 CRITICAL CARE MEDICINE

Burns Pub Date : 2025-02-05 DOI:10.1016/j.burns.2025.107417

Yaron Shoham , Lior Rosenberg , RP Narayan , Raphael Staubach , Ruzsena Bene , Mohan Kakola , Stan J. Monstrey , Yvonne Wilson , Manoj Jha , Giavonni M. Lewis , Shawn Larson , Adam J. Singer

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引用次数: 0

Abstract

Objectives

This study evaluated the safety and efficacy of an enzymatic bromelain-based debridement (BBD) agent (NexoBrid®) in children with deep thermal burns.

Methods

We conducted a multicenter, open-label, parallel design, randomized controlled trial at 36 burn centers in Europe, US, Israel and India. Main eligibility criteria included children 0–18 years old, suffering from deep thermal burns covering 1–30 % of their total body surface area. Patients were randomized to either BBD or standard of care (SOC) eschar removal methods. Primary endpoints included time to complete eschar removal (superiority), percentage of wound area surgically excised (superiority) and blinded 12 months follow-up assessment of cosmesis and function using the Modified Vancouver Scar Scale (MVSS, non-inferiority).

Results

One hundred and forty-five children were enrolled between 2015 and 2020 (last patient completed 12-month follow-up on April 2021); 72 were randomized to BBD and 73 to SOC. All three primary endpoints of the study were met. The median time to complete eschar removal was significantly lower in the BBD arm (1 vs. 6 days, P < 0.001). The mean [SD] percentage of wound area surgically excised was also significantly lower in the BBD arm (1.5 % [12.1 %] vs. 48.1 % [46.6 %], P < 0.001). Mean [SD] 12-month MVSS scores were 3.8 [2.9] and 4.9 [3.3] in the BBD and SOC arms, respectively (non-inferiority demonstrated at P < 0.001). The incidence of adverse events was similar between the groups, and there were no significant safety issues or deaths during the trial.

Conclusions

BBD was demonstrated to be safe and effective in children. Its use lead to a shorter time to complete eschar removal, a reduction in excisional surgery and non-inferior cosmesis and function results as compared to SOC eschar removal methods.

查看原文本刊更多论文

关于 NexoBrid 对烧伤儿童的疗效和安全性与标准护理相比的开放标签随机对照试验。

目的：本研究评估了一种酶促菠萝蛋白酶清创（BBD）剂（NexoBrid®）在儿童深度热烧伤中的安全性和有效性。方法：我们在欧洲、美国、以色列和印度的36个烧伤中心进行了一项多中心、开放标签、平行设计、随机对照试验。主要入选标准为0-18岁、体表面积占1- 30% %的深度热烧伤儿童。患者被随机分配到BBD或标准护理（SOC）痂清除方法。主要终点包括完成痂清除的时间（优势），手术切除伤口面积的百分比（优势）和使用改良温哥华疤痕量表（MVSS，非劣效性）进行的12个月的盲法随访美容和功能评估。结果：2015年至2020年期间纳入145名儿童（最后一名患者于2021年4月完成12个月的随访）；72例随机分为BBD组，73例随机分为SOC组。该研究的所有三个主要终点均得到满足。在BBD组中，完成痂清除的中位时间明显更短（1天vs. 6天，P ）。结论：BBD在儿童中被证明是安全有效的。与SOC结痂清除方法相比，它的使用缩短了完成结痂清除的时间，减少了切除手术，并获得了良好的美容和功能效果。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Burns 医学-皮肤病学

CiteScore

4.50

自引率

18.50%

发文量

304

审稿时长

72 days

期刊介绍： Burns aims to foster the exchange of information among all engaged in preventing and treating the effects of burns. The journal focuses on clinical, scientific and social aspects of these injuries and covers the prevention of the injury, the epidemiology of such injuries and all aspects of treatment including development of new techniques and technologies and verification of existing ones. Regular features include clinical and scientific papers, state of the art reviews and descriptions of burn-care in practice. Topics covered by Burns include: the effects of smoke on man and animals, their tissues and cells; the responses to and treatment of patients and animals with chemical injuries to the skin; the biological and clinical effects of cold injuries; surgical techniques which are, or may be relevant to the treatment of burned patients during the acute or reconstructive phase following injury; well controlled laboratory studies of the effectiveness of anti-microbial agents on infection and new materials on scarring and healing; inflammatory responses to injury, effectiveness of related agents and other compounds used to modify the physiological and cellular responses to the injury; experimental studies of burns and the outcome of burn wound healing; regenerative medicine concerning the skin.