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临床试验/NCT05924867
NCT05924867尚未招募不适用

Application of Plasma Activated Saline in Wound Treatment

First Affiliated Hospital Xi'an Jiaotong University1 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2023年7月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
162
试验地点
1
主要终点
The trends in wound healing rate

研究概览

简要总结

This is a prospective, open-label, randomized, parallel controlled clinical trial. The purpose of this study is to understand the application value of plasma-activated normal saline in the treatment of different types of wounds. The main questions it aims to answer are:

  1. What is the effect of plasma activated normal saline in promoting wound healing of different types?
  2. What is the safety of plasma activated normal saline in the treatment of wound surface? Subjects will be randomly divided into the intervention group and the control group. The intervention group will receive wound treatment with plasma activated normal saline, and the control group will receive routine dressing change treatment.

详细描述

As the population ages and antibiotic resistance increases, the chance of co-infection of various types of wounds increases greatly, resulting in prolonged wounds healing and eventually leading to bloodstream infections caused by germs, which can develop into life-threatening sepsis in severe cases. Plasma active saline is rich in reactive oxygen groups (ROS) and reactive nitrogen groups (RNS). It has good anti-inflammatory effect and is a potential new material to control wound infection and promote wound healing. Therefore, the purpose of this study was to apply plasma-activated water to different types of wounds and evaluate the effect of plasma-activated water on promoting healing of different types of wounds. And security issues in the application process.

This study is a prospective, open label, randomized, parallel controlled trial. This study is expected to include 162 subjects, including 46 patients with postoperative incision infection, 34 patients with postoperative incision fat liquefaction, and 82 patients with cutaneous infectious ulcer. The participants will be randomly divided into intervention group and control group by grouping randomized method. The intervention group will be treated with plasma activated water flushing and wet compress, and the control group will be treated with routine dressing change. The investigators will collect participants' wound conditions, blood, microbiological tests and other relevant indicators during treatment and follow-up.

To analyze the efficacy and safety of plasma-activated saline in the treatment of different wounds, the investigators will use independent sample T-test and K-M methods to compare the efficacy of the two groups, use descriptive analysis to represent the type and frequency of adverse events.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

The trends in wound healing rate

时间窗: 1 day up to 21 days

Wound healing rate=Number of healing cases/total cases ×100%

次要结局

  • The number of participants who tested positive for the etiology of wound exudates or extracts(The indicators will be collected at day 1, 7, 14 and 21 after the start of treatment.)
  • The number of adverse event(These indicators will be collected at 1, 7, 14, and 21 days after starting treatment, and at 1 week and 1 month after ending treatment.)
  • The number of participants with wound effusion(The indicators will be collected at day 1, 7, 14 and 21 after the start of treatment)
  • Wound pain score(The indicators will be collected at day 1, 7, 14 and 21 after the start of treatment.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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