Tissue Expander DisorderNCT03129763

Perfusion Assessment With Indocyanine Green-SPY Angiography After Tissue Expander Filling

A study testing 60mmHg capsule pressure expansion, 70mmHg capsule pressure expansion and 80mmHg capsule pressure expansion in people with Tissue Expander Disorder, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to optimize the expansion pressure by compare different capsule pressures' effect, the blood supply of expanded skin is assessed by the Indocyanine Green-SPY Angiography. Read more about this study

Who is it for?: Ages 18 to 50 years
Conditions the study is for: Tissue Expander Disorder
What is being tested?: 60mmHg capsule pressure expansion, 70mmHg capsule pressure expansion and 80mmHg capsule pressure expansion
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteChina
Study dates: 7 Jan 2017to 25 May 2017
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 18 to 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Age of 18 to 50 years;
Expanding skin donor site at the face, neck, anterior chest wall or back;
Implanted silicone expander of 100 to 600 ml in size; The quantitiy of normal saline in the tissue expander is more than the original volume, and less than double original volume.
Need for further skin expansion; with previous regular expanding in hospital;

Who cannot join

Iodine allergy; Indocyanine green allergy;
Not fit for soft tissue expansion treatment;
Evidence of infection, ischemia, ulcer or other pathological changes within the targeting area which defined as not suitable for expansion; or history of delayed healing, radiational therapy;
Significant renal, cardiovascular, hepatic and psychiatric diseases;
Significant medical diseases or infection (including but not limited to the carrier of hepatitis B virus or HIV)
BMI >30;

Show all 9Show fewer

History of any hematological disease, including leukopenia , thrombocytopenia, or thrombocytosis;
History of allogenic bone marrow transplantation;
Long history of smoking;Evidence of malignant diseases or unwillingness to participate.

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200011

Other trials in China

About this study

Official title: Perfusion Assessment With Indocyanine Green-SPY Angiography After Tissue Expander Filling for Optimization of Expansion Capsule Pressure

The purpose of this study is to optimize the expansion pressure by compare different capsule pressures' effect, the blood supply of expanded skin is assessed by the Indocyanine Green-SPY Angiography.

Read the detailed description

This is a randomized controlled trial that designed to optimize the tissue expander expanding method. All the patients were randomly divided into five groups, patients in different groups received an expansion weekly with different capsule pressure of 60mmHg, 70mmHg, 80mmHg, 90mmHg and 100mmHg respectively. Each patient received an expanding once a week, and a hemodynamic assessment of SPY-ICG angiography every two weeks. The total follow-up for each patient is 8 weeks.

Conditions: Tissue Expander Disorder
Being tested: 60mmHg capsule pressure expansion, 70mmHg capsule pressure expansion, 80mmHg capsule pressure expansion, 90mmHg capsule pressure expansion, 100mmHg capsule pressure expansion
Keywords: SPY-ICG Angiography, Tissue Expander, Capsule Pressure, Blood Supply

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

60mmHg capsule pressure expansionBehavioural
With a self-made apparatus composed of a spring-loaded sphygmomanometer and a disposable three-way pipe, the capsule pressure is measured. Increasing capsule pressure till 60mmHg.
70mmHg capsule pressure expansionBehavioural
With a self-made apparatus composed of a spring-loaded sphygmomanometer and a disposable three-way pipe, the capsule pressure is measured. Increasing capsule pressure till 70mmHg.
80mmHg capsule pressure expansionBehavioural
With a self-made apparatus composed of a spring-loaded sphygmomanometer and a disposable three-way pipe, the capsule pressure is measured. Increasing capsule pressure till 80mmHg.
90mmHg capsule pressure expansionBehavioural
With a self-made apparatus composed of a spring-loaded sphygmomanometer and a disposable three-way pipe, the capsule pressure is measured. Increasing capsule pressure till 90mmHg.
100mmHg capsule pressure expansionBehavioural
With a self-made apparatus composed of a spring-loaded sphygmomanometer and a disposable three-way pipe, the capsule pressure is measured. Increasing capsule pressure till 100mmHg.

Study groups in NCT03129763
Study group	Role	What they receive
60mmHg Group	Experimental	60mmHg capsule pressure expansion. This pressure depends on the ideal capsule pressure that previous study given. Receives: Behavioral: 60mmHg capsule pressure expansion
70mmHg Group	Experimental	70mmHg capsule pressure expansion. This pressure gradient depends on the ideal capsule pressure that previous study given, and the regular expansion pressure in recent studies. Receives: Behavioral: 70mmHg capsule pressure expansion
80mmHg Group	Experimental	80mmHg capsule pressure expansion. This pressure gradient depends on the ideal capsule pressure that previous study given, and the regular expansion pressure in recent studies. Receives: Behavioral: 80mmHg capsule pressure expansion
90mmHg Group	Experimental	90mmHg capsule pressure expansion. This pressure gradient depends on the ideal capsule pressure that previous study given, and the regular expansion pressure in recent studies. Receives: Behavioral: 90mmHg capsule pressure expansion
100mmHg Group	Experimental	100mmHg capsule pressure expansion. This pressure gradient depends on the regular expansion pressure in recent studies. Receives: Behavioral: 100mmHg capsule pressure expansion

What is being measured

The primary outcome is the main question the study is designed to answer.

Expanded Skin Fluorescence Intensity Decrease Rate in Venous Phase (Unit per-second)
Engress Rate is one of the expanded skin perfusion relative quantitative index of Indocyanine Green-SPY Angiography. It is obtained by SPY-Q analysis, which represents the flow of expanded skin veins.
Measured: Baseline at visit 1, and post-expanding every two weeks in the follow-up.

Secondary outcomes (3)

Expanded Skin Fluorescence Intensity Increasion Rate in Arterial Phase (Unit per-second)
Ingress Rate is one of the expanded skin perfusion relative quantitative index of Indocyanine Green-SPY Angiography. It is obtained by SPY-Q analysis, which represents the flow of expanded skin arteries.
Measured: Baseline at visit 1, and post-expanding every two weeks in the follow-up.
Expanded Skin Fluorescence Intensity Increasion in Arterial Phase (Unit)
Ingress is one of the expanded skin perfusion relative quantitative index of Indocyanine Green-SPY Angiography. It is obtained by SPY-Q analysis, which represents the absolute value of expanded skin fluorescence intensity increasion in arterial phase.
Measured: Baseline at visit 1, and post-expanding every two weeks in the follow-up.
Expanded Skin Fluorescence Intensity Decrease in Venous Phase (Unit)
Engress is one of the expanded skin perfusion relative quantitative index of Indocyanine Green-SPY Angiography. It is obtained by SPY-Q analysis, which represents the absolute value of expanded skin fluorescence intensity decrease in venous phase.
Measured: Baseline at visit 1, and post-expanding every two weeks in the follow-up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jan 201725 May 2017

First posted26 Apr 2017
Study start7 Jan 2017
Primary completion5 May 2017
Study completion25 May 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Tissue Expander DisorderStudies of the same condition, open and under way.
More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This is a prospective randomized controlled trial.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03129763
Sponsor's protocol ID: [2017]13
Status last verified: May 2017
First submitted: 14 Apr 2017
Last updated: 31 May 2017
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
A Study of Antibiotic Delivery to Prevent Infection After Breast Tissue Expander Placement
Breast Cancer
RecruitingObservational study
Postoperative Outcomes and Patient Satisfaction With Mayo Clinic Florida Care Hotel After Mastectomy and Tissue Expander Placement
Breast Carcinoma
Not yet recruitingPhase 3
The Comparison Between DEDTI BR and T/E BR
Breast Cancer
Active, not recruitingObservational study
Study of the Safety of MRI Scans in People Who Have Breast Tissue Expanders After Mastectomy
Breast Cancer, Breast Neoplasms
Not yet recruitingObservational study
EXpander-based Versus Direct to Implant PRE-pectoral Breast Reconstruction: a Comparative Analysis of Surgical Outcomes
Breast Cancer, Operable Breast Cancer

All Tissue Expander Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Perfusion Assessment With Indocyanine Green-SPY Angiography After Tissue Expander Filling for Optimization of Expansion Capsule Pressure
ClinicalTrials.gov ID: NCT03129763
Acronym / sponsor ID: [2017]13
Conditions: Tissue Expander Disorder
Keywords: SPY-ICG Angiography, Tissue Expander, Capsule Pressure, Blood Supply
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
Study start: 7 Jan 2017 (actual)
Primary completion: 5 May 2017 (actual)
Study completion: 25 May 2017 (actual)
First posted: 26 Apr 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.

The purpose of this study is to optimize the expansion pressure by compare different capsule pressures' effect, the blood supply of expanded skin is assessed by the Indocyanine Green-SPY Angiography.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 5
Model description: This is a prospective randomized controlled trial.

Arm	Type	Receives
60mmHg Group	Experimental	Behavioral: 60mmHg capsule pressure expansion60mmHg capsule pressure expansion. This pressure depends on the ideal capsule pressure that previous study given.
70mmHg Group	Experimental	Behavioral: 70mmHg capsule pressure expansion70mmHg capsule pressure expansion. This pressure gradient depends on the ideal capsule pressure that previous study given, and the regular expansion pressure in recent studies.
80mmHg Group	Experimental	Behavioral: 80mmHg capsule pressure expansion80mmHg capsule pressure expansion. This pressure gradient depends on the ideal capsule pressure that previous study given, and the regular expansion pressure in recent studies.
90mmHg Group	Experimental	Behavioral: 90mmHg capsule pressure expansion90mmHg capsule pressure expansion. This pressure gradient depends on the ideal capsule pressure that previous study given, and the regular expansion pressure in recent studies.
100mmHg Group	Experimental	Behavioral: 100mmHg capsule pressure expansion100mmHg capsule pressure expansion. This pressure gradient depends on the regular expansion pressure in recent studies.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Age of 18 to 50 years;
Expanding skin donor site at the face, neck, anterior chest wall or back;
Implanted silicone expander of 100 to 600 ml in size; The quantitiy of normal saline in the tissue expander is more than the original volume, and less than double original volume.
Need for further skin expansion; with previous regular expanding in hospital;

Key exclusion criteria (9 listed)

Iodine allergy; Indocyanine green allergy;
Not fit for soft tissue expansion treatment;
Evidence of infection, ischemia, ulcer or other pathological changes within the targeting area which defined as not suitable for expansion; or history of delayed healing, radiational therapy;
Significant renal, cardiovascular, hepatic and psychiatric diseases;
Significant medical diseases or infection (including but not limited to the carrier of hepatitis B virus or HIV)

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
60mmHg capsule pressure expansionWith a self-made apparatus composed of a spring-loaded sphygmomanometer and a disposable three-way pipe, the capsule pressure is measured. Increasing capsule pressure till 60mmHg.	Behavioural	60mmHg Group
70mmHg capsule pressure expansionWith a self-made apparatus composed of a spring-loaded sphygmomanometer and a disposable three-way pipe, the capsule pressure is measured. Increasing capsule pressure till 70mmHg.	Behavioural	70mmHg Group
80mmHg capsule pressure expansionWith a self-made apparatus composed of a spring-loaded sphygmomanometer and a disposable three-way pipe, the capsule pressure is measured. Increasing capsule pressure till 80mmHg.	Behavioural	80mmHg Group
90mmHg capsule pressure expansionWith a self-made apparatus composed of a spring-loaded sphygmomanometer and a disposable three-way pipe, the capsule pressure is measured. Increasing capsule pressure till 90mmHg.	Behavioural	90mmHg Group
100mmHg capsule pressure expansionWith a self-made apparatus composed of a spring-loaded sphygmomanometer and a disposable three-way pipe, the capsule pressure is measured. Increasing capsule pressure till 100mmHg.	Behavioural	100mmHg Group

Primary outcome

Expanded Skin Fluorescence Intensity Decrease Rate in Venous Phase (Unit per-second)
Time frame: Baseline at visit 1, and post-expanding every two weeks in the follow-up.
Engress Rate is one of the expanded skin perfusion relative quantitative index of Indocyanine Green-SPY Angiography. It is obtained by SPY-Q analysis, which represents the flow of expanded skin veins.

3 secondary outcomes

Expanded Skin Fluorescence Intensity Increasion Rate in Arterial Phase (Unit per-second)
Time frame: Baseline at visit 1, and post-expanding every two weeks in the follow-up.
Expanded Skin Fluorescence Intensity Increasion in Arterial Phase (Unit)
Time frame: Baseline at visit 1, and post-expanding every two weeks in the follow-up.
Expanded Skin Fluorescence Intensity Decrease in Venous Phase (Unit)
Time frame: Baseline at visit 1, and post-expanding every two weeks in the follow-up.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.

Related trials for Tissue Expander Disorder

RecruitingPhase 4
A Study of Antibiotic Delivery to Prevent Infection After Breast Tissue Expander Placement
Breast Cancer
RecruitingObservational study
Postoperative Outcomes and Patient Satisfaction With Mayo Clinic Florida Care Hotel After Mastectomy and Tissue Expander Placement
Breast Carcinoma
Not yet recruitingPhase 3
The Comparison Between DEDTI BR and T/E BR
Breast Cancer
Active, not recruitingObservational study
Study of the Safety of MRI Scans in People Who Have Breast Tissue Expanders After Mastectomy
Breast Cancer, Breast Neoplasms
Not yet recruitingObservational study
EXpander-based Versus Direct to Implant PRE-pectoral Breast Reconstruction: a Comparative Analysis of Surgical Outcomes
Breast Cancer, Operable Breast Cancer

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.

Qingfeng Li, MD; PhD study director

Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 9 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: finished, as of the sponsor's last update on 31 May 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Expanded Skin Fluorescence Intensity Decrease Rate in Venous Phase (Unit per-second) (time frame: Baseline at visit 1, and post-expanding every two weeks in the follow-up.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03129763.

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 31 May 2017.