Study of Tissue Expansion Devices Complications (STEDC)

March 14, 2017 updated by: Xijing Hospital

Intervention Study of Common Complications About Patients Placed Tissue Expansion Devices

Reduce the common complications incidence about patients placed tissue expansion devices to around 5%.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Study design： Randomized parallel controlled trial. Study comments: 1.Telephone follow-up trainment group about 2-3 months until secondary hospital. 2.Promote the health management manual of patient placed expander,which includes discharge list, injection list, expander affusion operation procedure, injection myth, you ask me answer,injection record, injection diary record, appointment diaries etc.

Study Type

Interventional

Enrollment (Anticipated)

208

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • xiaoling Wang
        • Contact:
        • Contact:
        • Principal Investigator:
          • qing Yang, docterate

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • aged 1-70 years male and female;
  • no complication when inclusion;
  • sign the informed consent.

Exclusion Criteria:

  • joined other clinical trial;
  • occurred complications before inclusion;
  • other infectious diseases;
  • the pregnant or lactating women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: manuals and follow-up
distribute manuals for patients before discharge and telephone follow-up per week until secondary hospital
Behavioral: manuals and follow-up
distribute manuals for patients before discharge and telephone follow-up per week until secondary hospital
No Intervention: controlled group
no intervention until secondary hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of patients suffered the common complications
Time Frame: 2-3 months until secondary hospital
count up the number of patients suffered the common complications
2-3 months until secondary hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Collaborators

First Affiliated Hospital Xi'an Jiaotong University

Investigators

  • Principal Investigator: qing Yang, doctorate, First Affiliated Hospital of Fourth Military Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2016

Primary Completion (Anticipated)

February 28, 2018

Study Completion (Anticipated)

February 28, 2018

Study Registration Dates

First Submitted

February 4, 2017

First Submitted That Met QC Criteria

March 14, 2017

First Posted (Actual)

March 21, 2017

Study Record Updates

Last Update Posted (Actual)

March 21, 2017

Last Update Submitted That Met QC Criteria

March 14, 2017

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KY20162083-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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