Tissue ExpansionSTEDCNCT03084887
Study of Tissue Expansion Devices Complications
A study testing manuals and follow-up in people with Tissue Expansion, run by Xijing Hospital at 1 site in China.
Trial summary
Reduce the common complications incidence about patients placed tissue expansion devices to around 5%. Read more about this study
- Who is it for?
- Ages 1 year to 70 years
- Conditions the study is for
- Tissue Expansion
- What is being tested?
- manuals and follow-up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2016to 28 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- aged 1-70 years male and female;
- no complication when inclusion;
- sign the informed consent.
Who cannot join
- joined other clinical trial;
- occurred complications before inclusion;
- other infectious diseases;
- the pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
xiaoling Wang
Xi'an, Shaanxi, 710032
xiaoling Wang, master, +86 18009290090, wxl_20070925@126.com
yanyan Jia, master, +86 02984771794, jiayanyan-2004@hotmail.com
About this study
Official title: Intervention Study of Common Complications About Patients Placed Tissue Expansion Devices
Reduce the common complications incidence about patients placed tissue expansion devices to around 5%.
Read the 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.
- Conditions
- Tissue Expansion
- Being tested
- manuals and follow-up
- Keywords
- Tissue Expansion Devices, Tissue Expansion, common complications, intervention study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manuals and follow-upBehavioural
distribute manuals for patients before discharge and telephone follow-up per week until secondary hospital
| Study group | Role | What they receive |
|---|---|---|
| manuals and follow-up | Experimental | distribute manuals for patients before discharge and telephone follow-up per week until secondary hospital Receives: Behavioral: manuals and follow-up |
| controlled group | No intervention | no intervention until secondary hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of patients suffered the common complications
count up the number of patients suffered the common complications
Measured: 2-3 months until secondary hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start10 Nov 2016
- Primary completion28 Feb 2018 (estimated)
- Study completion28 Feb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tissue ExpansionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital Xi'an Jiaotong University
- Responsible party
- Sponsor
- Investigators
- qing Yang, doctorate, Principal investigator, First Affiliated Hospital of Fourth Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03084887
- Sponsor's protocol ID
- KY20162083-1
- Acronym
- STEDC
- Status last verified
- Nov 2016
- First submitted
- 4 Feb 2017
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Study of Common Complications About Patients Placed Tissue Expansion Devices
- ClinicalTrials.gov ID
- NCT03084887
- Acronym / sponsor ID
- STEDC / KY20162083-1
- Conditions
- Tissue Expansion
- Keywords
- Tissue Expansion Devices, Tissue Expansion, common complications, intervention study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital Xi'an Jiaotong University
- Study start
- 10 Nov 2016 (actual)
- Primary completion
- 28 Feb 2018 (estimated)
- Study completion
- 28 Feb 2018 (estimated)
- First posted
- 21 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| manuals and follow-up | Experimental | Behavioral: manuals and follow-updistribute manuals for patients before discharge and telephone follow-up per week until secondary hospital |
| controlled group | No intervention | –no intervention until secondary hospital |
Who may qualify
- Ages
- 1 year to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- aged 1-70 years male and female;
- no complication when inclusion;
- sign the informed consent.
Key exclusion criteria (4 listed)
- joined other clinical trial;
- occurred complications before inclusion;
- other infectious diseases;
- the pregnant or lactating women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| manuals and follow-updistribute manuals for patients before discharge and telephone follow-up per week until secondary hospital | Behavioural | manuals and follow-up |
Primary outcome
incidence of patients suffered the common complications
Time frame: 2-3 months until secondary hospital
count up the number of patients suffered the common complications
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Tissue Expansion
Recruiting
Blossom® Smart Expander Device for Tissue Expander/Implant-Based Breast Reconstruction
Tissue Expansion, Implant Based Breast Reconstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
qing Yang, doctorate principal investigator
First Affiliated Hospital of Fourth Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing manuals and follow-up in people with Tissue Expansion, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoling Wang, master (+86 18009290090, wxl_20070925@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of patients suffered the common complications (time frame: 2-3 months until secondary hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2017; AzTrials last refreshed its copy on 1 Nov 2026.