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Completed

NCT Number: NCT03365037

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

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

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Key information

Conditions

Soft Tissue Injuries Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electret electrostatic physiotherapyFilm

Drug

Patients with acute soft tissue injury treated with electret electrostatic physiotherapyFilm

Other names: polypropylene

Fracture healing film

Drug

Patients with acute soft tissue injury treated with Fracture healing film

Other names: Teflon,2011-2640661

Primary outcomes

  1. Number of cured persons

    Time frame: 7 days after treatment (±2 days)

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

Secondary outcomes

  1. Number of adverse events

    Time frame: 7 days after treatment (±2 days)

    allergic skin rash

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Dec 7, 2017
Registry last updated
Dec 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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