Study of Therapeutic Effect of Electret Static Physiotherapy Film on Acute Soft Tissue Closed Injury

Study Overview
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Brief Summary
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The aim of this study was to evaluate the efficacy and safety of electret static physiotherapy film developed by Beijing Youshilin science and Technology Development Co., Ltd., to treat acute soft tissue injury by sticking to the affected area

Detailed Description
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Design of randomized, open, parallel controlled non inferiority clinical trial.A total of 60 patients were included in the trial, including 30 subjects in the experimental group and 30 subjects in the control group. The experimental disease was acute soft tissue closed injury.

Official Title
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Study of Therapeutic Effect of Electret Static Physiotherapy Film on Acute Soft Tissue Closed Injury

Conditions
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Soft Tissue Injuries

Intervention / Treatment
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* Drug: Electret electrostatic physiotherapyFilm
* Drug: Fracture healing film


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with acute soft tissue injury diagnosed by Western Medicine Ability to communicate well with the researcher and comply with the requirements of the validation Participants agreed to participate in the clinical validation and follow the validation program requirements, and signed the informed consent form Exclusion Criteria: There are important organs (heart and lung) serious disease history, or have autoimmune disease history, such as rheumatism, SLE, or have a history of immune dysfunction, such as suffering from aids Patients with cardiac pacemaker Patients with open wounds Pregnant and lactating women Patients with history of mental illness Participants participated in other medical device trials or drug clinical trials within three months The researchers believe that the participants who are not eligible for clinical validation should be considered Patients who need to be treated with drugs Patients requiring physical therapy

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
Interventional Model Description: A randomized, open, parallel controlled, non inferiority clinical trial design was used in this trial.Objective to evaluate the safety and effectiveness of electret static physiotherapy film in Beijing Youshilin science and Technology Development Co., Ltd.The patients were followed up after receiving the electret static physiotherapy film, and the treatment and complication rate of the patients were observed after the electret static physiotherapy film was attached to the patient.The data were compared between the experimental group and the control group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electret electrostatic physiotherapyFilm<br>Patients with acute soft tissue injury treated with electret electrostatic physiotherapyFilm | Drug: Electret electrostatic physiotherapyFilm<br>* Patients with acute soft tissue injury treated with electret electrostatic physiotherapyFilm<br>* Other names: polypropylene;|
| Active Comparator: Fracture healing film<br>Patients with acute soft tissue injury treated with fracture healing film | Drug: Fracture healing film<br>* Patients with acute soft tissue injury treated with Fracture healing film<br>* Other names: Teflon,2011-2640661;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cured persons | Pain, swelling, bruising and other symptoms and signs of integration to reduce more than 95%, the normal joint movement | 7 days after treatment (±2 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events | allergic skin rash | 7 days after treatment (±2 days) |