Plasma Activated Saline in Wound Treatment

Study Overview
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Brief Summary
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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
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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.

Official Title
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Application of Plasma Activated Saline in Wound Treatment

Conditions
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Wound, Wound Infection, Wound Heal

Intervention / Treatment
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* Other: plasma activated saline
* Other: Routine nursing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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. | Other: plasma activated saline<br>* 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.<br>|
| Active Comparator: Control group<br>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. | Other: Routine nursing<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The trends in wound healing rate | Wound healing rate=Number of healing cases/total cases ×100% | 1 day up to 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 indicators will be collected at day 1, 7, 14 and 21 after the start of treatment | 
| 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. | The indicators will be collected at day 1, 7, 14 and 21 after the start of treatment. | 
| 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 indicators will be collected at day 1, 7, 14 and 21 after the start of treatment. | 
| 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. | 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. |