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

NCT ID: NCT03365037

Last Updated: 2017-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-01

Study Completion Date

2012-09-30

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.

Conditions

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Soft Tissue Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Electret electrostatic physiotherapyFilm

Patients with acute soft tissue injury treated with electret electrostatic physiotherapyFilm

Group Type EXPERIMENTAL

Electret electrostatic physiotherapyFilm

Intervention Type DRUG

Patients with acute soft tissue injury treated with electret electrostatic physiotherapyFilm

Fracture healing film

Patients with acute soft tissue injury treated with fracture healing film

Group Type ACTIVE_COMPARATOR

Fracture healing film

Intervention Type DRUG

Patients with acute soft tissue injury treated with Fracture healing film

Interventions

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Electret electrostatic physiotherapyFilm

Patients with acute soft tissue injury treated with electret electrostatic physiotherapyFilm

Intervention Type DRUG

Fracture healing film

Patients with acute soft tissue injury treated with Fracture healing film

Intervention Type DRUG

Other Intervention Names

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polypropylene Teflon,2011-2640661

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhang Yichong

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peixun Zhang, Doctor

Role: STUDY_CHAIR

Peking University People's Hospital

Locations

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Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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PKUPH20121030A

Identifier Type: -

Identifier Source: org_study_id