Back to resultsPlasma Activated Saline in Wound Treatment
Primary Purpose
Wound, Wound Infection, Wound Heal
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
plasma activated saline
Routine nursing
Sponsored by
About this trial
This is an interventional treatment trial for Wound
Eligibility Criteria
Inclusion Criteria Group of postoperative incision infection Age ≥18 years old, ≤75 years old, gender unlimited. Clinical diagnosis of postoperative incision infection. Must be no significant risk of head trauma or closed injury to the chest and abdomen. Fully understand the study content and subjects' rights and interests, and sign the informed consent. Group of postoperative incision fat liquefaction Age ≥18 years old, ≤75 years old, gender unlimited. Clinical diagnosis of postoperative incision fat liquefaction. Must be no incision infection or organ infection was involved in deep surgery, and no other serious complications occurred. Must be no significant risk of head trauma or closed injury to the chest and abdomen. Fully understand the study content and subjects' rights and interests, and sign the informed consent. Group of infectious ulcers Age ≥18 years old, ≤75 years old, gender unlimited. Clinical diagnosis of superficial skin ulcer infection caused by various causes, which can have one or more wounds. The formation time of the wound surface exceeds 1 month. Fully understand the study content and subjects' rights and interests, and sign the informed consent. Exclusion Criteria Allergic to multiple drugs, dressings, gels or materials used in this study. Functional injury of cardiopulmonary system, with obvious risk of craniocerebral trauma or severe closed injury of chest and abdomen. Severe malnutrition, hypoproteinemia, moderate to severe anemia. Pregnant or lactating women (lactating female subjects can still be included if they agree to stop breastfeeding during the treatment period and within one week after the last medication). Patients with active wound bleeding, poor mental condition and critical condition. Poor glycemic control of diabetes mellitus; Severe malnutrition, hypoproteinemia, moderate and severe anemia. The presence of inflammatory skin diseases, such as atopic dermatitis or eczema, that affect efficacy and safety evaluation. Poor glycemic control of diabetes mellitus; Severe malnutrition, severe cardiopulmonary disease, hypertension, widespread local necrosis requiring immediate toe amputation. Combined with anaerobic bacteria infection, wet gangrene, abdominal infection, hematogenous infection, and intra-articular infection. Ulcers caused by diabetic feet and malignant tumors. History of glucocorticoid use and anticoagulant drug use within 12 months before enrollment. History of immune disease or immunosuppressant use. Poor compliance due to cognitive impairment or mental illness. Any conditions that the investigator considered might increase the risk to the subject or affect the evaluation of efficacy.
Sites / Locations
- First Affiliated Hospital of Xian JiaotongUniversity
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
Control group
Arm Description
The wounds of participants in the postoperative incision infection group and ulcer infection group will be given plasma activated saline irrigation (100 ml plasma activated saline for every 10 cm2 wound), drainage, and wet compress. The wounds of participants in the fat liquefaction group will be uniformly rinsed with plasma saline for 5-10 min to clean the incision, then drained and suction with negative pressure. The researchers will determine the dressing change time according to the size of the patient's wound and the number of secretions, starting every day or every other day, and waiting for the incision to be fresh or less secretions at an interval of 2-3 days.
The wounds of participants in the postoperative incision infection group and ulcer infection group will receive routine dressing change treatment, namely cleaning with chlorhexidine disinfectant (100 ml chlorhexidine disinfectant for every 10 cm2 wound area), drainage, bandaging. The wounds of participants in the fat liquefaction group will be receive conventional treatment, namely negative pressure sputum aspiration. The researchers will determine the dressing change time according to the size of the patient's wound and the number of secretions, starting every day or every other day, and waiting for the incision to be fresh or less secretions at an interval of 2-3 days.
Outcomes
Primary Outcome Measures
The trends in wound healing rate
Wound healing rate=Number of healing cases/total cases ×100%
Secondary Outcome Measures
The number of participants with wound effusion
Observe whether there is fluid, pus and other exudation on the wound and the number of days when the effusion disappeared will be recorded.
The number of participants who tested positive for the etiology of wound exudates or extracts
Check whether there is bacterial infection and infected strains on the wound.
Wound pain score
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.
The number of adverse event
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.
Full Information
NCT ID
NCT05924867
First Posted
June 12, 2023
Last Updated
July 5, 2023
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
1. Study Identification
Unique Protocol Identification Number
NCT05924867
Brief Title
Plasma Activated Saline in Wound Treatment
Official Title
Application of Plasma Activated Saline in Wound Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 20, 2023 (Anticipated)
Primary Completion Date
June 20, 2024 (Anticipated)
Study Completion Date
June 20, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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:
What is the effect of plasma activated normal saline in promoting wound healing of different types?
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound, Wound Infection, Wound Heal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
162 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The wounds of participants in the postoperative incision infection group and ulcer infection group will be given plasma activated saline irrigation (100 ml plasma activated saline for every 10 cm2 wound), drainage, and wet compress. The wounds of participants in the fat liquefaction group will be uniformly rinsed with plasma saline for 5-10 min to clean the incision, then drained and suction with negative pressure.
The researchers will determine the dressing change time according to the size of the patient's wound and the number of secretions, starting every day or every other day, and waiting for the incision to be fresh or less secretions at an interval of 2-3 days.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The wounds of participants in the postoperative incision infection group and ulcer infection group will receive routine dressing change treatment, namely cleaning with chlorhexidine disinfectant (100 ml chlorhexidine disinfectant for every 10 cm2 wound area), drainage, bandaging. The wounds of participants in the fat liquefaction group will be receive conventional treatment, namely negative pressure sputum aspiration.
The researchers will determine the dressing change time according to the size of the patient's wound and the number of secretions, starting every day or every other day, and waiting for the incision to be fresh or less secretions at an interval of 2-3 days.
Intervention Type
Other
Intervention Name(s)
plasma activated saline
Intervention Description
The plasma activated normal saline used in the intervention was prepared by a self-made machine, and the safety of the plasma activated water produced by the machine has passed the national quality inspection.
Intervention Type
Other
Intervention Name(s)
Routine nursing
Intervention Description
For postoperative incision infection group and infected ulcer group, conventional dressing change treatment was given, namely chlorhexidine disinfectant washing, drainage and bandaging; For the fat liquefaction group, conventional treatment was given, namely negative pressure suction.
Primary Outcome Measure Information:
Title
The trends in wound healing rate
Description
Wound healing rate=Number of healing cases/total cases ×100%
Time Frame
1 day up to 21 days
Secondary Outcome Measure Information:
Title
The number of participants with wound effusion
Description
Observe whether there is fluid, pus and other exudation on the wound and the number of days when the effusion disappeared will be recorded.
Time Frame
The indicators will be collected at day 1, 7, 14 and 21 after the start of treatment
Title
The number of participants who tested positive for the etiology of wound exudates or extracts
Description
Check whether there is bacterial infection and infected strains on the wound.
Time Frame
The indicators will be collected at day 1, 7, 14 and 21 after the start of treatment.
Title
Wound pain score
Description
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.
Time Frame
The indicators will be collected at day 1, 7, 14 and 21 after the start of treatment.
Title
The number of adverse event
Description
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.
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Group of postoperative incision infection
Age ≥18 years old, ≤75 years old, gender unlimited.
Clinical diagnosis of postoperative incision infection.
Must be no significant risk of head trauma or closed injury to the chest and abdomen.
Fully understand the study content and subjects' rights and interests, and sign the informed consent.
Group of postoperative incision fat liquefaction
Age ≥18 years old, ≤75 years old, gender unlimited.
Clinical diagnosis of postoperative incision fat liquefaction.
Must be no incision infection or organ infection was involved in deep surgery, and no other serious complications occurred.
Must be no significant risk of head trauma or closed injury to the chest and abdomen.
Fully understand the study content and subjects' rights and interests, and sign the informed consent.
Group of infectious ulcers
Age ≥18 years old, ≤75 years old, gender unlimited.
Clinical diagnosis of superficial skin ulcer infection caused by various causes, which can have one or more wounds.
The formation time of the wound surface exceeds 1 month.
Fully understand the study content and subjects' rights and interests, and sign the informed consent.
Exclusion Criteria
Allergic to multiple drugs, dressings, gels or materials used in this study.
Functional injury of cardiopulmonary system, with obvious risk of craniocerebral trauma or severe closed injury of chest and abdomen.
Severe malnutrition, hypoproteinemia, moderate to severe anemia.
Pregnant or lactating women (lactating female subjects can still be included if they agree to stop breastfeeding during the treatment period and within one week after the last medication).
Patients with active wound bleeding, poor mental condition and critical condition.
Poor glycemic control of diabetes mellitus; Severe malnutrition, hypoproteinemia, moderate and severe anemia.
The presence of inflammatory skin diseases, such as atopic dermatitis or eczema, that affect efficacy and safety evaluation.
Poor glycemic control of diabetes mellitus; Severe malnutrition, severe cardiopulmonary disease, hypertension, widespread local necrosis requiring immediate toe amputation.
Combined with anaerobic bacteria infection, wet gangrene, abdominal infection, hematogenous infection, and intra-articular infection.
Ulcers caused by diabetic feet and malignant tumors.
History of glucocorticoid use and anticoagulant drug use within 12 months before enrollment.
History of immune disease or immunosuppressant use.
Poor compliance due to cognitive impairment or mental illness.
Any conditions that the investigator considered might increase the risk to the subject or affect the evaluation of efficacy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miao Runchen, PhD
Phone
0086-18229097849
Email
miaozao91@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wang Saiyu, Master
Phone
0086-15670590777
Email
wsy321567@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liu Chang, PhD
Organizational Affiliation
First Affiliated Hospital Xi'an Jiaotong University
Official's Role
Study Director
Facility Information:
Facility Name
First Affiliated Hospital of Xian JiaotongUniversity
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang Liu, PhD
Phone
0086-18991232095
Email
liuchangfh@xjtu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Plasma Activated Saline in Wound Treatment
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