Plasma Activated Saline in Wound Treatment

Not Applicable

Not yet recruiting

• Conditions: Wound Infection; Wound; Wound Heal

• Registration Number: NCT05924867
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-12
• Study First Submitted QC: 2023-06-27
• Study First Posted: 2023-06-29
• Last Update Submitted: 2023-07-05
• Last Update Posted: 2023-07-06
• Study Start: 2023-07-20
• Primary Completion: 2024-06-20
• Study Completion: 2024-06-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The trends in wound healing rate	1 day up to 21 days	Wound healing rate=Number of healing cases/total cases ×100%

Secondary Outcome Measures

Name	Time	Method
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.	Check whether there is bacterial infection and infected strains on the wound.
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.	In this trial, any adverse medical event occurring within 30 days after the subject's signing of the informed consent to the final dose, regardless of whether there is a causal relationship with the test drug, is considered to be an adverse event. Adverse events and descriptions of all associated symptoms, such as time of occurrence, severity, duration, action taken, final outcome and outcome, will be recorded.
The number of participants with wound effusion	The indicators will be collected at day 1, 7, 14 and 21 after the start of treatment	Observe whether there is fluid, pus and other exudation on the wound and the number of days when the effusion disappeared will be recorded.
Wound pain score	The indicators will be collected at day 1, 7, 14 and 21 after the start of treatment.	Wound pain will be measured on the Visual Analogue Scale with a minimum score of 0 and a maximum score of 10 on the VAS, 0 indicating no pain at all, 10 indicating severe pain that is unbearable, and a higher score indicating more severe pain.

Trial Locations

Locations (1)

First Affiliated Hospital of Xian JiaotongUniversity; 🇨🇳 Xi'an, Shaanxi, China