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

Soft Tissue Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03365037
• Other study ID #: PKUPH20121030A
• Status: Completed
• Phase: N/A
• First received: November 25, 2017
• Last updated: December 5, 2017
• Start date: April 1, 2012
• Est. completion date: September 30, 2012

Study information

• Verified date: December 2017
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 30, 2012
• Est. primary completion date: September 30, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Soft Tissue Injuries
• Wounds and Injuries

Intervention

Drug:
• Electret electrostatic physiotherapyFilm
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

Locations

Country	Name	City	State
China	Peking University People's Hospital	Peking	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of adverse events	allergic skin rash	7 days after treatment (±2 days)