Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy.
Division of Endocrinology and Diabetology, Department of Medical Sciences, Fondazione Policlinico "Tor Vergata", Rome, Italy.
J Wound Care. 2024 Oct 2;33(10):756-770. doi: 10.12968/jowc.2024.0208.
Several national and international guidelines recommend lipidocolloid technology with a nano-oligosaccharide factor (TLC-NOSF) dressings (UrgoStart dressing range, Laboratoires Urgo, France) for treating patients with chronic wounds. However, these dressings are still often reported as second-line options, potentially leading to loss of opportunity for patients and additional costs for payers. This review aimed to explore the reported wound healing and patient outcomes as well as the related costs when the dressings were used as first-line treatment in patients with different types of chronic wounds.
A systematic review of the literature was conducted. Databases (MEDLINE, Embase, Emcare, and Google Scholar) were searched up to 1 February 2024, without any language or time period limitations. Studies were eligible if the evaluated dressings had been used as a first-line treatment for chronic wounds, that is, as an integral part of the standard of care (SoC) at the patient's first presentation and/or in recent wounds. The main evaluation criteria included: wound healing rate; time to reach wound closure; change in patients' quality of life (QoL); and associated costs. The quality of evidence of the included studies was appraised using well-recognised risk-of-bias tools suitable for different study designs. A narrative synthesis describes the findings in three sections depending on the type of comparison. This report followed the principles of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.
A total of 17 studies published between 2017 and 2024 met the eligibility criteria. A comparative analysis between TLC-NOSF dressings and standard dressings, both of which were used as first-line treatment, was reported in nine studies. A comparative analysis between the use of TLC-NOSF dressings as first-line and second-line treatments was reported in eight studies, and five studies reported a systematic use of the TLC-NOSF dressing as first-line treatment without a control group. Overall, the included studies had a relatively low risk of bias for the respective types of evidence. Data of 10,191 patients of both sexes and different age groups with a total of 10,203 wounds (diabetic foot ulcers, leg ulcers, pressure injuries, and other types of chronic wounds) were included in the analysis: 7775 treated with the evaluated dressing and 2428 treated with a comparator dressing. The data suggested that using TLC-NOSF as a first-line treatment for chronic wounds consistently resulted in significantly higher healing rates, shorter healing times, and cost savings compared with standard dressings used under similar conditions. Real-life evidence confirmed the results obtained in clinical trials and economic models, within similar ranges, regardless of the settings involved or of the characteristics of the patients and wounds treated. The wound healing rates ranged around 70-80% by week 20/24 and time-to-heal was reported on average around seven weeks, with slightly longer times reported in wounds with a more severe prognosis. Furthermore, the dressings were shown to improve patient QoL, and were well tolerated and accepted, supporting a wider adoption approach.
The results of this review are aligned with the current guidelines recommending the use of TLC-NOSF dressings in the treatment of patients with chronic wounds. They support its wider implementation as a first-line treatment and as an integral part of SoC for these wounds in the daily practice of all centres involved in their management.
多项国内外指南建议使用含纳米寡糖因子(TLC-NOSF)的脂质胶体技术敷料(UrgoStart 敷料系列,Laboratoires Urgo,法国)治疗慢性伤口患者。然而,这些敷料仍常被报告为二线选择,可能导致患者错失机会并增加支付方的费用。本综述旨在探讨当这些敷料作为不同类型慢性伤口患者的一线治疗时,报告的伤口愈合和患者结局以及相关成本。
对文献进行系统综述。检索了 MEDLINE、Embase、Emcare 和 Google Scholar 数据库,截至 2024 年 2 月 1 日,无任何语言或时间限制。如果评估的敷料被用作慢性伤口的一线治疗,即作为患者首次就诊和/或近期伤口的标准治疗(SoC)的一部分,那么研究就符合纳入标准。主要评估标准包括:伤口愈合率;达到伤口闭合的时间;患者生活质量(QoL)的变化;以及相关成本。使用适用于不同研究设计的公认的风险偏倚工具评估纳入研究的证据质量。根据比较类型,叙述性综合描述了研究结果。本报告遵循系统评价和荟萃分析首选报告项目的原则。
共有 17 项发表于 2017 年至 2024 年的研究符合纳入标准。9 项研究报告了 TLC-NOSF 敷料与标准敷料之间的比较,两者均作为一线治疗使用。8 项研究报告了 TLC-NOSF 敷料作为一线和二线治疗的比较,5 项研究报告了 TLC-NOSF 敷料作为一线治疗的系统使用,没有对照组。总体而言,纳入研究各自类型的证据具有相对较低的偏倚风险。分析共纳入了来自 10191 名男女患者的 10203 处伤口(糖尿病足溃疡、腿部溃疡、压疮和其他类型的慢性伤口):7775 例接受评估敷料治疗,2428 例接受对照敷料治疗。数据表明,与类似条件下使用的标准敷料相比,TLC-NOSF 作为慢性伤口的一线治疗可显著提高愈合率、缩短愈合时间并节省成本。真实世界的证据在类似范围内证实了临床试验和经济模型中获得的结果,无论涉及的环境或治疗的患者和伤口特征如何。伤口愈合率在第 20/24 周时约为 70-80%,报告的平均愈合时间约为 7 周,预后更严重的伤口报告的时间略长。此外,敷料还被证明可以改善患者的 QoL,并具有良好的耐受性和接受度,支持更广泛的应用方法。
本综述的结果与当前建议在慢性伤口治疗中使用 TLC-NOSF 敷料的指南一致。它们支持将其作为一线治疗以及这些伤口 SoC 的一部分更广泛地应用于日常管理中涉及的所有中心。