Plasma Activated Saline in Wound Treatment

Wound Heal Clinical Trial

Official title: Application of Plasma Activated Saline in Wound Treatment

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Wound
• Wound Heal
• Wound Infection
• Wounds and Injuries

• NCT number: NCT05924867
• Study type: Interventional
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Miao Runchen, PhD
• Phone: 0086-18229097849
• Email: miaozao91@163.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 20, 2023
• Completion date: June 20, 2024