An innovative multicomponent compression system in a single bandage for venous leg ulcer and/or oedema treatment: a real-life study in 343 patients.

IF 1.5 4区医学 Q3 DERMATOLOGY

Journal of wound care Pub Date : 2025-01-02 Epub Date: 2024-12-16 DOI:10.12968/jowc.2024.0375

Joachim Dissemond, Christoph Schicker, Tino Breitfeld, Winfried Keuthage, Elisa Häuser, Udo Möller, Laetitia Thomassin, Markus Stücker

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引用次数: 0

Abstract

Objective: This study aimed to evaluate the performance of an innovative multicomponent compression system in a single bandage (UrgoK1, Laboratoires Urgo, France) in the treatment of patients with venous leg ulcers (VLUs) and/or lower limb oedema in everyday practice.

Method: A prospective, observational, clinical study with the evaluated compression system was conducted in 39 centres in Germany between March 2022 and July 2023. Main outcomes included a description of the treated patients, changes in wound healing and oedema progression, local tolerance and acceptability of the compression system.

Results: In total, 343 patients were treated with the evaluated compression system for a mean period of 48±30 days; 196 had a VLU and 275 had oedema, mostly of venous origin. By the final visit, 49% of VLUs healed (75% in absence of oedema and 61% in VLUs of ≤1 month's duration). Oedema was completely resolved or greatly improved in 87% of patients, with significant reduction in calf and ankle circumferences. Improvement in pruritus, pain, age-related ankle mobility and skin changes were also reported in patients who experienced them at baseline. The system was judged 'very easy' to apply (median: 108 seconds, three times a week), 'extremely useful' and 'very well accepted' by most patients who reported an improvement in comfort compared with previous systems. Similar results were observed when patients and/or their relatives were involved in the bandage application between the study visits. During the study, three cases of local intolerance related to the system and five early terminations (unrelated to the system) were reported.

Conclusion: These results are consistent with the previous clinical evidence available on this new compression system and further support its good efficacy, tolerability, acceptability and usefulness in the treatment of patients with VLUs and/or oedema.

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一种用于腿部静脉溃疡和/或水肿治疗的单绷带创新多组分压缩系统：343例患者的现实研究。

目的：本研究旨在评估一种创新的单绷带多成分压缩系统（UrgoK1, Laboratoires Urgo, France）在日常治疗下肢静脉性溃疡（VLUs）和/或下肢水肿患者中的表现。方法：在2022年3月至2023年7月期间，在德国的39个中心进行了一项前瞻性、观察性的临床研究。主要结果包括治疗患者的描述，伤口愈合和水肿进展的变化，局部耐受性和压迫系统的可接受性。结果：共有343例患者使用评估的压迫系统治疗，平均时间为48±30天；196例有VLU， 275例有水肿，主要是静脉源性水肿。到最后一次访问时，49%的vlu愈合（75%无水肿，61%持续时间≤1个月的vlu）。87%的患者水肿完全缓解或显著改善，小腿和脚踝围围显著减小。瘙痒、疼痛、与年龄相关的踝关节活动和皮肤变化的改善也在基线经历过的患者中得到报告。该系统被大多数患者评价为“非常容易”使用（中位数：108秒，每周三次），“非常有用”和“非常容易接受”，他们报告说，与以前的系统相比，舒适度有所改善。当患者和/或其亲属参与研究访问之间的绷带应用时，观察到类似的结果。在研究期间，报告了3例与该系统有关的局部不耐受病例和5例早期终止（与该系统无关）。结论：这些结果与先前关于这种新型压迫系统的临床证据一致，进一步支持其在治疗VLUs和/或水肿患者中的良好疗效、耐受性、可接受性和实用性。

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来源期刊

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.