Study of Tissue Expansion Devices Complications

NCT ID: NCT03084887

Last Updated: 2017-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-10

Study Completion Date

2018-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tissue Expansion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

manuals and follow-up

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

Group Type EXPERIMENTAL

manuals and follow-up

Intervention Type BEHAVIORAL

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

controlled group

no intervention until secondary hospital

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

manuals and follow-up

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role collaborator

Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

qing Yang, doctorate

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Fourth Military Medical University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

xiaoling Wang

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Xiaoling Wang, master

Role: CONTACT

+86 18009290090

yanyan Jia, master

Role: CONTACT

+86 02984771794

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

xiaoling Wang, master

Role: primary

+86 18009290090

yanyan Jia, master

Role: backup

+86 02984771794

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KY20162083-1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.