Study of Tissue Expansion Devices Complications | NCT03084887

Studies
Study of Tissue Expansion Devices Complications

NCT03084887

Sponsor

Xijing Hospital

Status

Unknown status

Last Update Posted

Mar 21, 2017Actual

Enrollment

208Estimated

Phase

Not Applicable

Conditions

Tissue Expansion

Interventions

manuals and follow-up

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 10, 2016Actual

Primary Completion Date

Feb 28, 2018Estimated

Completion Date

Feb 28, 2018Estimated

First Submitted Date

Feb 4, 2017

First Submission Date that Met QC Criteria

Mar 14, 2017

First Posted Date

Mar 21, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2017

Last Update Posted Date

Mar 21, 2017Actual

Name	Class
First Affiliated Hospital Xi'an Jiaotong University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

208Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
manuals and follow-up	Experimental	distribute manuals for patients before discharge and telephone follow-up per week until secondary hospital	Behavioral: manuals and follow-up
controlled group	No Intervention	no intervention until secondary hospital

Interventions

Name	Type	Description	Arm Group Labels	Other Names
manuals and follow-up	Behavioral	distribute manuals for patients before discharge and telephone follow-up per week until secondary hospital	manuals and follow-up

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiaoling Wang, master	Contact	+86 18009290090		wxl_20070925@126.com
yanyan Jia, master	Contact	+86 02984771794		jiayanyan-2004@hotmail.com

Overall Officials

Name	Affiliation	Role
qing Yang, doctorate	First Affiliated Hospital of Fourth Military Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
xiaoling Wang	Recruiting	Xi'an	Shaanxi	710032	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided