An interventional study of plasma activated saline and Routine nursing in Wound, Wound Infection and Wound Heal, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-07-06.
Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Not applicable, Interventional, and Treatment
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:
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.
382 studies on the registry are indexed under Wound Infection; 40 are open to participants now.
This study's planned enrollment of 162 is close to the median of 150 across 296 interventional studies indexed under Wound Infection.
Browse Wound Infection studies →First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 306 studies on the registry; 86 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Group of postoperative incision infection
Group of postoperative incision fat liquefaction
Group of infectious ulcers
Allergic to multiple drugs, dressings, gels or materials used in this study.
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
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
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.
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.
The trends in wound healing rate
Wound healing rate=Number of healing cases/total cases ×100%
Time frame: 1 day up to 21 days
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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.
Plan to share: Undecided
This study is not yet recruiting, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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First Affiliated Hospital Xi'an Jiaotong University