Study of Tissue Expansion Devices Complications

Tissue Expansion Clinical Trial

— STEDC  

Official title:

Intervention Study of Common Complications About Patients Placed Tissue Expansion Devices

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03084887
• Other study ID #: KY20162083-1
• Status: Recruiting
• Phase: N/A
• First received: February 4, 2017
• Last updated: March 14, 2017
• Start date: November 10, 2016
• Est. completion date: February 28, 2018

Study information

• Verified date: November 2016
• Source: Xijing Hospital
• Contact: Xiaoling Wang, master
• Phone: +86 18009290090
• Email: wxl_20070925[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 208
• Est. completion date: February 28, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tissue Expansion

Intervention

Behavioral:
• manuals and follow-up
distribute manuals for patients before discharge and telephone follow-up per week until secondary hospital

Locations

Country	Name	City	State
China	xiaoling Wang	Xi'an	Shaanxi

Sponsors (2)

Lead Sponsor	Collaborator
Xijing Hospital	First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of patients suffered the common complications	count up the number of patients suffered the common complications	2-3 months until secondary hospital