Lo C H, Wagstaff M J D, Barker T M, Damkat-Thomas L, Salerno S, Holden D, Concannon E, Heath K, Coghlan P, Cleland H
Victorian Adult Burns Service, The Alfred, 55 Commercial Rd, Melbourne, VIC 3004, Australia.
Department of Surgery, Central Clinical School, Monash University, 99 Commercial Rd, Melbourne, VIC 3004, Australia.
JPRAS Open. 2023 May 28;37:42-51. doi: 10.1016/j.jpra.2023.05.003. eCollection 2023 Sep.
BACKGROUND/AIM: NovoSorb Biodegradable Temporizing Matrix (BTM) is a relatively novel, biodegradable polyurethane-based dermal regeneration template. The aim of this study was to evaluate the long-term scarring outcomes and safety of BTM in patients who underwent dermal reconstruction involving ≥5% of the total body surface area.
This was a postmarket, multicenter, observational cohort study involving evaluation of long-term outcomes in patients treated with BTM. A total of 55 patients (35 from Royal Adelaide Hospital, South Australia, and 20 from Victoria Adult Burns Service, The Alfred, Victoria) who underwent dermal repair with BTM between 2011 and 2017 were screened for inclusion in this study. All patients had BTM implanted for ≥18 months.
Fifteen eligible patients with a mean (SD) age of 49.1 (14.3) years completed study assessments. These patients had a total of 39 areas treated with BTM. Using the Patient and Observer Scar Assessment Scale, scar quality was reported to be good by both observers and patients, with a mean (SD) observer score across all lesions of 3.6 (1.2) and mean (SD) overall opinion of 3.8 (1.2) as well as a mean (SD) patient score of 3.5 (1.2) and overall opinion of 5.0 (2.2). No adverse events or adverse device effects were reported or identified.
The long-term scar quality is comparable to published studies. BTM is safe in the long term with no additional risks or adverse consequences being identified.
背景/目的：NovoSorb生物可降解临时基质（BTM）是一种相对新颖的、基于生物可降解聚氨酯的皮肤再生模板。本研究的目的是评估BTM在进行了占全身表面积≥5%的皮肤重建患者中的长期瘢痕形成结果及安全性。
这是一项上市后多中心观察性队列研究，涉及对接受BTM治疗患者的长期结果进行评估。对2011年至2017年间接受BTM皮肤修复的55例患者（35例来自南澳大利亚皇家阿德莱德医院，20例来自维多利亚州阿尔弗雷德医院的维多利亚成人烧伤服务中心）进行筛选以纳入本研究。所有患者植入BTM的时间均≥18个月。
15例符合条件的患者，平均（标准差）年龄为49.1（14.3）岁，完成了研究评估。这些患者共有39个部位接受了BTM治疗。使用患者和观察者瘢痕评估量表，观察者和患者均报告瘢痕质量良好，所有病变的观察者平均（标准差）评分为3.6（1.2），总体平均意见评分为3.8（1.2），患者平均（标准差）评分为3.5（1.2），总体意见评分为5.0（2.2）。未报告或发现不良事件或器械不良影响。
长期瘢痕质量与已发表的研究相当。BTM长期安全，未发现额外风险或不良后果。
