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

Peking University

Status

Completed

Conditions

Soft Tissue Injuries

Treatments

Drug: Fracture healing film

Drug: Electret electrostatic physiotherapyFilm

Study type

Interventional

Funder types

Other

Identifiers

NCT03365037

PKUPH20121030A

Details and patient eligibility

About

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

Full description

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.

Enrollment

60 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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