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

Primary Purpose

Soft Tissue Injuries

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Electret electrostatic physiotherapyFilm
Fracture healing film
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Soft Tissue Injuries

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Peking University People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Electret electrostatic physiotherapyFilm

Fracture healing film

Arm Description

Patients with acute soft tissue injury treated with electret electrostatic physiotherapyFilm

Patients with acute soft tissue injury treated with fracture healing film

Outcomes

Primary Outcome Measures

Number of cured persons
Pain, swelling, bruising and other symptoms and signs of integration to reduce more than 95%, the normal joint movement

Secondary Outcome Measures

Number of adverse events
allergic skin rash

Full Information

First Posted
November 25, 2017
Last Updated
December 5, 2017
Sponsor
Peking University People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03365037
Brief Title
Study of Therapeutic Effect of Electret Static Physiotherapy Film on Acute Soft Tissue Closed Injury
Official Title
Study of Therapeutic Effect of Electret Static Physiotherapy Film on Acute Soft Tissue Closed Injury
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
April 1, 2012 (Actual)
Primary Completion Date
September 30, 2012 (Actual)
Study Completion Date
September 30, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electret electrostatic physiotherapyFilm
Arm Type
Experimental
Arm Description
Patients with acute soft tissue injury treated with electret electrostatic physiotherapyFilm
Arm Title
Fracture healing film
Arm Type
Active Comparator
Arm Description
Patients with acute soft tissue injury treated with fracture healing film
Intervention Type
Drug
Intervention Name(s)
Electret electrostatic physiotherapyFilm
Other Intervention Name(s)
polypropylene
Intervention Description
Patients with acute soft tissue injury treated with electret electrostatic physiotherapyFilm
Intervention Type
Drug
Intervention Name(s)
Fracture healing film
Other Intervention Name(s)
Teflon,2011-2640661
Intervention Description
Patients with acute soft tissue injury treated with Fracture healing film
Primary Outcome Measure Information:
Title
Number of cured persons
Description
Pain, swelling, bruising and other symptoms and signs of integration to reduce more than 95%, the normal joint movement
Time Frame
7 days after treatment (±2 days)
Secondary Outcome Measure Information:
Title
Number of adverse events
Description
allergic skin rash
Time Frame
7 days after treatment (±2 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peixun Zhang, Doctor
Organizational Affiliation
Peking University People's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Peking University People's Hospital
City
Peking
State/Province
Beijing
ZIP/Postal Code
100044
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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