维克利恩®:一种新的伤口保护剂,配备了用于腹部手术的垃圾收集袋
Jianmin Qian1,2, Ying Xiong3, Hailong Ju1
1Haize Institute for Applied Medical Research (Wuxi), Wuxi, Jiangsu, China.
Surgical innovation
|December 26, 2025
概括
一种新的Viclean®伤口保护剂通过收集手术内液体,有效地控制手术部位的污染. 该设备在腹部手术,特别是剖腹产期间预防手术部位感染方面表现有前途.
科学领域:
- 手术方面的创新.
- 医疗器械开发 医疗器械开发
- 感染控制的方法是感染控制.
背景情况:
- 手术部位感染 (SSI) 是开放腹部手术中与医疗相关的严重并发症.
- 传统的伤口保护剂在防止大量手术内排放的污染方面存在局限性,特别是在剖腹产期间.
- 有效的伤口保护对于降低SSI风险至关重要.
研究的目的:
- 介绍和评估Viclean®,这是一款具有集成废物收集系统的新型双环伤口保护剂.
- 评估设备能够将手术场和伤口边缘与手术内污水隔离出来的能力.
- 确定Viclean®在开放腹部手术期间预防污染的临床实用性和性能.
主要方法:
- 开发Viclean®,一种由医用级热塑性聚氨 (TPU) 制成的双环伤口保护剂,配备废物收集袋和灵活的排水系统.
- 临床观察Viclean®在紧急剖腹产和选择性开放左半角切除术期间的性能.
- 根据ISO 13485:2016质量系统对产品生物相容性,无菌性和包装验证进行评估.
主要成果:
- 在紧急剖腹产期间,Viclean®有效地转移了羊水,防止了切口和手术场的污染.
- 该设备在开放式左半球切除术期间成功地排出了肠道废水和灌液,保持了干净干燥的伤口边缘.
- 手术团队报告了关于Viclean®临床功效的积极评价.
结论:
- 在开放腹部手术期间,Viclean®在管理大量废水方面表现良好.
- 该设备有效地隔离了手术部位的污染,可能降低了手术部位感染的风险.
- 维克利恩®已经完成了必要的验证,并在多个地区获得了监管批准,表明它已准备好用于更广泛的临床应用.
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