Andreas Degenhardt, Thomas Reinbold, Christoph Weinhardt
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Inclusion parameters were acute wounds (surgical or laceration) in patients with at least one fragile skin condition. Endpoints included: the percentage of adhered dressing area seven days after application of the dressings; and evaluation of any signs of skin damage and erythema following dressing removal. Furthermore, self-reported patient pain, comfort during dressing wear, and the health professionals' ease of dressing handling with gloves were assessed.</p><p><strong>Results: </strong>A total of 42 patients with fragile skin and surgical wounds (35 patients) or lacerations (7 patients) were recruited. Mean age was 78 years. There were no signs of erythema following dressing removal and no MARSI (skin stripping, blister, skin tears, maceration, irritant contact dermatitis or allergic dermatitis) occurred at removal after seven days of wear time. Data demonstrated a reliable wound coverage with sufficient adhesion without negatively affecting the periwound skin and wound improvement was observed in 94% of patients. The vast majority of patients reported minimal pain at removal, reduced wound pain and high satisfaction with wearing comfort. Health professionals found the dressings easy to apply and remove, even with gloved hands.</p><p><strong>Conclusion: </strong>The results of this real-world evidence showed effective and well-tolerated use of transparent dressings with silicone adhesive in patients with fragile skin. 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引用次数: 0
摘要
目的:目前,有关特定硅酮粘合剂产品的粘合质量、疼痛和临床表现,以及它们在保持皮肤完整性和预防医用粘合剂相关皮肤损伤(MARSI)方面的作用的实际研究十分有限。本文介绍了对两种硅酮粘合剂敷料的性能和安全参数进行的临床评估,这些敷料在日常实践中用于脆弱皮肤的撕裂伤或手术伤口及其周围皮肤:方法:2021 年 6 月至 2022 年 11 月期间,在德国的三个地点对 Leukomed T 皮肤敏感型和 Leukomed T plus 皮肤敏感型(均为 BSN medical GmbH,Essity Group)进行了一项观察性、前瞻性、多中心、非对照的上市后临床观察研究。纳入参数为至少有一种皮肤脆弱情况的患者的急性伤口(手术或撕裂伤)。终点包括:使用敷料七天后敷料粘附面积的百分比;去除敷料后皮肤损伤和红斑迹象的评估。此外,还对患者自述的疼痛感、敷料穿着时的舒适度以及医护人员戴手套处理敷料的难易程度进行了评估:共招募了 42 名皮肤脆弱、有手术伤口(35 名)或撕裂伤(7 名)的患者。平均年龄为 78 岁。去除敷料后没有红斑迹象,七天后去除敷料时也没有出现MARSI(皮肤剥脱、水泡、皮肤撕裂、浸渍、刺激性接触性皮炎或过敏性皮炎)。数据显示,敷料能可靠地覆盖伤口,具有足够的粘附性,不会对伤口周围的皮肤产生负面影响,94% 的患者的伤口得到了改善。绝大多数患者都表示在取下敷料时疼痛极小,伤口疼痛减轻,对穿着的舒适度非常满意。医护人员发现,即使戴着手套,敷料也很容易穿脱:这一真实世界的证据结果表明,在皮肤脆弱的患者中使用带硅胶粘合剂的透明敷料是有效且耐受性良好的。这种敷料可以降低皮肤损伤的风险,包括MARSI,同时还能为患者提供较高的穿着舒适度,并实现几乎无痛的换药。
Performance and safety of transparent postoperative dressings with silicone adhesive in daily practice on fragile skin.
Objective: Currently there is limited real-world research on the adhesion qualities, pain and clinical performance of specific silicone adhesives products, and their role in maintaining skin integrity and preventing medical adhesive-related skin injuries (MARSI). This paper presents a clinical evaluation of performance and safety parameters of two silicone adhesive dressings on lacerations or surgical wounds and the surrounding skin in daily practice on fragile skin.
Method: An observational, prospective, multicentre, uncontrolled post-market clinical observational study with Leukomed T skin sensitive and Leukomed T plus skin sensitive (both BSN medical GmbH, Essity Group) was undertaken at three sites across Germany between June 2021 to November 2022. Inclusion parameters were acute wounds (surgical or laceration) in patients with at least one fragile skin condition. Endpoints included: the percentage of adhered dressing area seven days after application of the dressings; and evaluation of any signs of skin damage and erythema following dressing removal. Furthermore, self-reported patient pain, comfort during dressing wear, and the health professionals' ease of dressing handling with gloves were assessed.
Results: A total of 42 patients with fragile skin and surgical wounds (35 patients) or lacerations (7 patients) were recruited. Mean age was 78 years. There were no signs of erythema following dressing removal and no MARSI (skin stripping, blister, skin tears, maceration, irritant contact dermatitis or allergic dermatitis) occurred at removal after seven days of wear time. Data demonstrated a reliable wound coverage with sufficient adhesion without negatively affecting the periwound skin and wound improvement was observed in 94% of patients. The vast majority of patients reported minimal pain at removal, reduced wound pain and high satisfaction with wearing comfort. Health professionals found the dressings easy to apply and remove, even with gloved hands.
Conclusion: The results of this real-world evidence showed effective and well-tolerated use of transparent dressings with silicone adhesive in patients with fragile skin. The dressings may reduce the risk of skin damage including MARSI, while providing patients a high wearing comfort and allowing an almost pain-free dressing change.
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.