含有无菌人羊膜的 AMNIODERM+® 伤口敷料的临床评估:回顾性-前瞻性临床试验。

IF 2.7 Q3 BIOTECHNOLOGY & APPLIED MICROBIOLOGY
BioTech Pub Date : 2024-09-19 DOI:10.3390/biotech13030036
Iveta Schmiedova, Petr Slama, Alena Dembickaja, Beata Kozova, Vendula Hyneckova, Sona Gogolkova, Elen Stastna, Michal Zahradnicek, Stefan Savic, Arash Davani, Edward Hulo, Emil Martinka
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引用次数: 0

摘要

慢性伤口是人体无法愈合的结果,会造成疼痛、病原体侵入、有限的治疗选择和社会负担。糖尿病足溃疡尤其具有挑战性,往往会导致截肢等严重并发症。一项临床研究对 AMNIODERM+® 进行了测试,这是一种使用冻干人羊膜 (HAM) 的新型设备,用于治疗慢性糖尿病足溃疡。参与者的糖尿病神经性或神经缺血性腿部伤口(2-16 平方厘米)在接受标准护理六周后仍有 20% 的伤口未愈合。这项研究表明,AMNIODERM+® 能明显改善伤口愈合。12 周后,伤口面积缩小的中位数为 95.5%,远远超过了 20% 变化的无效假设。此外,65% 的患者溃疡完全愈合,超过了 50% 的疗效要求。完全闭合的中位时间为 11.4 周,完全愈合患者的比例逐步上升,在第 11 周时达到 55%。冷冻干燥羊膜治疗不愈合伤口 "临床试验的这些结果表明,AMNIODERM+® 是未来治疗慢性糖尿病足溃疡的一种很有前途的疗法。发表的结果是在一项名为 "冻干羊膜治疗伤口不愈合:单臂、回顾性前瞻性临床试验"(EUDAMED Nr.CIV-SK-22-10-041146。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Clinical Evaluation of AMNIODERM+® Wound Dressing Containing Non-Viable Human Amniotic Membrane: Retrospective-Perspective Clinical Trial.

Chronic wounds result from the body's inability to heal, causing pain, pathogen entry, limited treatment options, and societal burden. Diabetic foot ulcers are particularly challenging, often leading to severe complications like leg amputation. A clinical study tested AMNIODERM+®, a new device with a lyophilized human amniotic membrane (HAM), on chronic diabetic foot ulcers. Participants had diabetic neuropathic or neuroischemic leg wounds (2-16 cm2) unhealed by 20% after six weeks of standard care. This study showed significant wound healing improvements with AMNIODERM+®. The median wound size reduction after 12 weeks was 95.5%, far exceeding the null hypothesis of 20% change. Additionally, 65% of patients achieved complete ulceration healing, surpassing the 50% efficacy requirement. The median time to full closure was 11.4 weeks, with the proportion of completely healed patients rising progressively, reaching 55% by week 11. These findings, from the clinical trial "Freeze-dried amniotic membrane in the treatment of nonhealing wounds", suggest AMNIODERM+® as a promising future treatment for chronic diabetic foot ulcers. The published results were obtained as part of a clinical trial entitled "Freeze-dried amniotic membrane in the treatment of nonhealing wounds: a single-arm, retrospectively-perspective clinical trial", EUDAMED Nr. CIV-SK-22-10-041146.

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来源期刊
BioTech
BioTech Immunology and Microbiology-Applied Microbiology and Biotechnology
CiteScore
3.70
自引率
0.00%
发文量
51
审稿时长
11 weeks
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