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一种具有磨蚀性纤维和非磨蚀性纤维的清创垫的临床性能和安全性。

Clinical performance and safety of a debridement pad with abrasive and non-abrasive fibres.

机构信息

Department for Vascular Medicine, University Medical Center Hamburg-Eppendorf, Germany.

Huddersfield Royal Infirmary, UK.

出版信息

J Wound Care. 2024 Jun 2;33(6):408-416. doi: 10.12968/jowc.2024.0162.

DOI:10.12968/jowc.2024.0162
PMID:38843013
Abstract

BACKGROUND

Debridement is key to removing devitalised tissue, debris and biofilm as part of wound-bed preparation. Unlike many other methods of debridement, mechanical debridement with a pad is effective enough to be used independently without an adjunctive method of debridement, while being more accessible than other standalone options.

OBJECTIVE

To explore the clinical performance and safety of a debridement pad with both abrasive and non-abrasive surfaces in daily clinical practice.

METHODS

This was a prospective, non-controlled, non-randomised, single-arm, open-label, multicentred observational evaluation. Inclusion criteria were wounds >4 cm covered with at least 30% debris, necrotic tissue or slough in patients aged ≥18 years. The treatment protocol comprised a single application of the debridement pad. The primary outcome measure was the amount of necrotic tissue, slough or debris in the wound bed. Secondary outcomes included the appearance of the wound bed, edges and periwound skin; self-reported pain scores; foreseeable negative impacts; and clinician satisfaction.

RESULTS

A total of 62 participants with a variety of wound types were included in the analysis. Most wounds (87%) had been present for over 3 months and had high or moderate exudate levels (90%). A significant reduction was observed in all three parameters: necrotic tissue (p=0.043), slough (p<0.001) and debris (p<0.001). Necrotic tissue, slough and debris showed mean relative reductions of 40%, 72% and 40%, respectively. Of participants, 84% did not experience an increase in pain during the debridement procedure.

CONCLUSION

This clinical real-world data shows the debridement pad to be an effective and well-tolerated device for debridement and wound bed preparation.

摘要

背景

清创是去除失活组织、碎片和生物膜的关键,是创面准备的一部分。与许多其他清创方法不同,带垫的机械清创足以独立使用,无需辅助清创方法,同时比其他独立选择更容易获得。

目的

探索具有磨砂和非磨砂表面的清创垫在日常临床实践中的临床性能和安全性。

方法

这是一项前瞻性、非对照、非随机、单臂、开放性、多中心观察评估。纳入标准为伤口面积>4cm,有至少 30%的碎屑、坏死组织或腐肉,患者年龄≥18 岁。治疗方案包括单次应用清创垫。主要结局测量指标为创面床中坏死组织、腐肉或碎屑的量。次要结局包括创面床、边缘和周围皮肤的外观;自我报告的疼痛评分;可预见的负面影响;以及临床医生满意度。

结果

共有 62 名患有各种伤口类型的参与者被纳入分析。大多数伤口(87%)已经存在 3 个月以上,且渗出液水平较高或中度(90%)。所有三个参数均观察到显著减少:坏死组织(p=0.043)、腐肉(p<0.001)和碎屑(p<0.001)。坏死组织、腐肉和碎屑的平均相对减少分别为 40%、72%和 40%。84%的参与者在清创过程中没有感到疼痛增加。

结论

这些临床实际数据表明,清创垫是一种有效且耐受性良好的清创和创面准备设备。

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