A new portable negative pressure wound therapy device: a prospective study investigating clinical outcomes.

IF 1.5 4区 医学 Q3 DERMATOLOGY
Victoria Rose, Nadine Hachah Haram, Sarah Gallala
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引用次数: 0

Abstract

Objective: Closed surgical incision sites at high risk of complications, and with exudate or leakage, are increasingly being managed with closed incision negative pressure wound therapy (ciNPWT) to reduce tissue stress and increase the force necessary to disrupt the incision. This study was undertaken to investigate the performance and safety of a canister-based, single-use NPWT (suNPWT) system when used on closed surgical incision sites.

Method: The investigation was designed as a prospective, open, non-comparative, multicentre study aimed at confirming the safety and performance attributes of the suNPWT system when applied to low-to-moderately exuding closed surgical incisions. The primary performance measure was the wound remaining closed from baseline to the last follow-up visit on day 14. Secondary performance measures included: wound and periwound condition; wear time of the system; product consumption; adherence to therapy; and patients' pain progress. Details of adverse events were also collected.

Results: Some 35 patients were recruited. The closed surgical incisions responded well to treatment with the tested suNPWT system. All wounds remained closed throughout the investigation. Consistent with other studies of ciNPWT reporting low infection rates, the current study observed either no or low exudation in 90.4% of wounds at the final visit, together with absence of surgical site infection. Pain severity levels were low, both at dressing change and during delivery of negative pressure. No serious adverse device events were reported.

Conclusion: In this study, the suNPWT system supported the healing of closed surgical incisions with no safety concerns relating to its use.

一种新型便携式负压伤口治疗设备:一项调查临床效果的前瞻性研究。
目的:闭合手术切口部位并发症风险高,且有渗出或渗漏,越来越多的人采用闭合切口负压伤口疗法(ciNPWT)来减少组织应力和增加破坏切口所需的力量。本研究旨在调查在闭合手术切口部位使用罐式一次性负压伤口疗法(suNPWT)系统的性能和安全性:该研究是一项前瞻性、开放式、非比较性的多中心研究,旨在确认一次性无创水疗系统用于低度至中度渗液的闭合式手术切口时的安全性和性能属性。主要性能指标是伤口从基线到最后一次随访(第 14 天)期间保持闭合的情况。次要性能指标包括:伤口和伤口周围状况、系统佩戴时间、产品消耗量、治疗依从性和患者疼痛进展。此外,还收集了不良事件的详细信息:结果:共招募了约 35 名患者。经测试,闭合的手术切口对 suNPWT 系统的治疗反应良好。在整个调查过程中,所有伤口都保持闭合状态。与其他 ciNPWT 研究报告的低感染率一致,本研究观察到 90.4% 的伤口在最后检查时没有渗出或渗出较少,同时也没有手术部位感染。在换药和负压治疗期间,疼痛的严重程度都很低。没有关于设备严重不良事件的报告:在这项研究中,suNPWT 系统有助于闭合性手术切口的愈合,而且没有使用安全问题。
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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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