Study of Tissue Expansion Devices Complications

Not Applicable

• Conditions: Tissue Expansion
• Interventions: Behavioral: manuals and follow-up

• Registration Number: NCT03084887
• Lead Sponsor: Xijing Hospital

Brief Summary

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

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 Timeline

• Status Verified: 2016-11
• Study Start: 2016-11-10
• Study First Submitted: 2017-02-04
• Study First Submitted QC: 2017-03-14
• Last Update Submitted: 2017-03-14
• Study First Posted: 2017-03-21
• Last Update Posted: 2017-03-21
• Primary Completion: 2018-02-28
• Study Completion: 2018-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 208

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
manuals and follow-up	manuals and follow-up	distribute manuals for patients before discharge and telephone follow-up per week until secondary hospital

Primary Outcome Measures

Name	Time	Method
incidence of patients suffered the common complications	2-3 months until secondary hospital	count up the number of patients suffered the common complications

Trial Locations

Locations (1)

xiaoling Wang; 🇨🇳 Xi'an, Shaanxi, China