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

IF 1.5 4区 医学 Q3 DERMATOLOGY
Ewa Stürmer, Eike Sebastian Debus, Leanne Atkin
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引用次数: 0

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 cm2 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.

带有研磨纤维和非研磨纤维的清创垫的临床性能和安全性。
背景:作为伤口床准备工作的一部分,清创是清除坏死组织、碎屑和生物膜的关键。与许多其他清创方法不同,使用清创垫进行机械清创非常有效,无需辅助清创方法即可独立使用,而且比其他独立方法更容易获得:目的:探讨清创垫在日常临床实践中的临床表现和安全性:这是一项前瞻性、非对照、非随机、单臂、开放标签、多中心观察评估。纳入标准:年龄≥18 岁的患者,伤口面积大于 4 平方厘米,至少有 30% 的碎屑、坏死组织或蜕皮。治疗方案包括一次性使用清创垫。主要结果指标是伤口床坏死组织、蜕皮或碎屑的数量。次要结果包括伤口床、边缘和伤口周围皮肤的外观;自我报告的疼痛评分;可预见的负面影响;以及临床医生的满意度:共有 62 名不同类型伤口的参与者参与了分析。大多数伤口(87%)已存在 3 个月以上,渗液水平较高或中等(90%)。在所有三个参数上都观察到了明显的减少:坏死组织(p=0.043)、蜕皮(pConclusion):这一临床实际数据表明,清创垫是一种有效且耐受性良好的清创和伤口床准备设备。
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来源期刊
Journal of wound care
Journal of wound care DERMATOLOGY-
CiteScore
2.90
自引率
10.50%
发文量
215
期刊介绍: Journal of Wound Care (JWC) is the definitive wound-care journal and the leading source of up-to-date research and clinical information on everything related to tissue viability. The journal was first launched in 1992 and aimed at catering to the needs of the multidisciplinary team. Published monthly, the journal’s international audience includes nurses, doctors and researchers specialising in wound management and tissue viability, as well as generalists wishing to enhance their practice. In addition to cutting edge and state-of-the-art research and practice articles, JWC also covers topics related to wound-care management, education and novel therapies, as well as JWC cases supplements, a supplement dedicated solely to case reports and case series in wound care. All articles are rigorously peer-reviewed by a panel of international experts, comprised of clinicians, nurses and researchers. Specifically, JWC publishes: High quality evidence on all aspects of wound care, including leg ulcers, pressure ulcers, the diabetic foot, burns, surgical wounds, wound infection and more The latest developments and innovations in wound care through both preclinical and preliminary clinical trials of potential new treatments worldwide In-depth prospective studies of new treatment applications, as well as high-level research evidence on existing treatments Clinical case studies providing information on how to deal with complex wounds Comprehensive literature reviews on current concepts and practice, including cost-effectiveness Updates on the activities of wound care societies around the world.
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