Ignite Creation Date:
2024-05-06 @ 7:12 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05924867
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-06
First Post:
2023-06-12
Brief Title:
Plasma Activated Saline in Wound Treatment
Sponsor:
First Affiliated Hospital Xian Jiaotong University
Organization:
First Affiliated Hospital Xian Jiaotong University
Study Overview
Official Title:
Application of Plasma Activated Saline in Wound Treatment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None