使用酸化氧化溶液治疗难治性腿部溃疡与常规护理的对比：MACAN 研究。

Management of hard-to-heal leg ulcers with an acid-oxidising solution versus standard of care: the MACAN study.

机构信息

Department of Dermatology, Federal Academic Teaching Hospital of Feldkirch, Austria.

Center for Medical Statistics, Informatics, and Intelligent Systems, Medical University of Vienna, Austria.

出版信息

J Wound Care. 2021 Sep 2;30(9):694-704. doi: 10.12968/jowc.2021.30.9.694.

DOI:10.12968/jowc.2021.30.9.694

PMID:34554831

Abstract

OBJECTIVE

The efficacy of available wound dressings in the treatment of hard-to-heal wounds is limited. A new therapeutic approach using an acid-oxidising solution (AOS) was developed. Its effect on healing progress, tolerability and safety properties were investigated in a clinical study, and compared with standard of care (SOC) wound dressings. The study aimed to demonstrate the non-inferiority of AOS to SOC in terms of wound healing progress.

METHOD

This open-label, randomised controlled trial was conducted at two study centres in Austria with patients with either infected or non-infected hard-to-heal leg ulcers of different aetiology. Patients were treated for six weeks either with AOS or SOC wound dressings. Outcome assessments included the percentage of granulation and re-epithelialisation tissue, wound size reduction, changes in wound pH, infection control and wound pain, local tolerability and adverse events (AEs). Healing time and rate were also assessed.

RESULTS

A total of 50 patients took part. In the AOS group, wounds exhibited higher amounts of granulation and re-epithelialisation tissue, and a faster and more pronounced wound size reduction compared with wounds in the SOC group. In the AOS-treated versus SOC-treated patients, a greater percentage of complete healing of hard-to-heal ulcers was achieved by the end of the study period (32% versus 8%, respectively). Furthermore, the wound pH decreased significantly faster in these wounds (p<0.0001). In all patients with infected leg ulcers, local infection was overcome more rapidly under AOS treatment. In the AOS group, one AE and no serious adverse events (SAEs) were detected versus 24 AEs and two SAEs in the SOC group.

CONCLUSION

In this study, AOS proved to be a highly effective treatment to support wound healing in infected or non-infected hard-to-heal leg ulcers of different aetiology. Efficacy was found to be not only non-inferior but superior to SOC wound dressings. Furthermore, tolerability and safety profiles were favourable for AOS.

摘要

目的

现有的创面敷料在治疗难愈性创面方面的疗效有限。为此，我们开发了一种新的治疗方法，即使用酸氧化溶液（AOS）。本临床研究旨在评估 AOS 对愈合进展、耐受性和安全性的影响，并与标准治疗（SOC）创面敷料进行比较，旨在证明 AOS 在愈合进展方面不劣于 SOC。

方法

这是一项在奥地利的 2 家研究中心进行的开放性、随机对照试验，纳入了不同病因的感染性或非感染性难愈性腿部溃疡患者。患者接受 AOS 或 SOC 创面敷料治疗 6 周。疗效评估包括肉芽组织和再上皮化组织的百分比、创面缩小程度、创面 pH 值变化、感染控制情况和创面疼痛、局部耐受性和不良事件（AE）。还评估了愈合时间和愈合率。

结果

共有 50 例患者参与了研究。与 SOC 组相比，AOS 组的创面具有更高比例的肉芽组织和再上皮化组织，且创面缩小速度更快、程度更显著。研究结束时，AOS 组治疗的难愈性溃疡完全愈合的患者比例明显更高（分别为 32%和 8%）。此外，这些创面的 pH 值下降速度更快（p<0.0001）。所有感染性腿部溃疡患者的局部感染在 AOS 治疗下更快得到控制。AOS 组中仅发现 1 例 AE 和 0 例严重不良事件（SAE），而 SOC 组中则发现 24 例 AE 和 2 例 SAE。