NCT03084887

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
208

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 10, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 21, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
Last Updated

March 21, 2017

Status Verified

November 1, 2016

Enrollment Period

1.3 years

First QC Date

February 4, 2017

Last Update Submit

March 14, 2017

Conditions

Tissue Expansion

Keywords

Tissue Expansion DevicesTissue Expansioncommon complicationsintervention study

Outcome Measures

Primary Outcomes (1)

  • incidence of patients suffered the common complications

    count up the number of patients suffered the common complications

    2-3 months until secondary hospital

Study Arms (2)

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

manuals and follow-upBEHAVIORAL

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

manuals and follow-up

Eligibility Criteria

Age1 Year - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • aged 1-70 years male and female;
  • sign the informed consent.

You may not qualify if:

  • joined other clinical trial;
  • other infectious diseases;
  • the pregnant or lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

xiaoling Wang

Xi'an, Shaanxi, 710032, China

RECRUITING

Study Officials

  • qing Yang, doctorate

    First Affiliated Hospital of Fourth Military Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoling Wang, master

CONTACT

+86 18009290090wxl_20070925@126.com

yanyan Jia, master

CONTACT

+86 02984771794jiayanyan-2004@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2017

First Posted

March 21, 2017

Study Start

November 10, 2016

Primary Completion

February 28, 2018

Study Completion

February 28, 2018

Last Updated

March 21, 2017

Record last verified: 2016-11

Locations

CN(1)