ScarPhase 1/2NCT02809001
The Effects of Autologous Fat Transfer on Preventing Expanded Skin From Expansion Failure
A Phase 1/2 study testing Fat grafting in people with Scar and Nevus, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The purpose of this study is to evaluate whether autologous fat grafting is safe and/or effective to prevent expanded skin from expansion failure. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- What is being tested?
- Fat grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Jan 2011to May 2016
- Phase
- Phase 1/2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Expanding skin donor site at the face, neck, anterior chest wall, abdominal wall or back;
- Implanted silicone expander of 50 to 800 ml in size;
- History of deterioration in the expanded skin texture that did not improve after the inflation procedure was suspended for more than 2 weeks;
- Persistent high level of expander internal pressure;
- Need for further skin expansion;
Who cannot join
- 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;
- Rupture of expanded skin, expander exposure;
- 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 less than 17 or insufficient subcutaneous fat;
- History of any hematological disease, including leukopenia , thrombocytopenia, or thrombocytosis;
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- History of allogenic bone marrow transplantation;
- Pregnant or lactating woman;
- Long history of smoking;
- Evidence of malignant diseases or unwillingness to participate
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate whether autologous fat grafting is safe and/or effective to prevent expanded skin from expansion failure.
Read the detailed description
The repair of skin defects is a common problem for reconstructive surgeons.Soft tissue expansion is a widely used technique for the repair of skin defects. Early expansion-related complications such as skin thinning, telangiectasia, and striae may result in expansion failure and ultimately jeopardize final outcome. In the past years, discontinuation of the expansion procedure was the only therapeutic option, when early alarm signs such as semitransparent appearance and telangiectasia of the expanded skin were encountered. We aimed to overcome these complications by therapeutic fat grafting to prevent skin necrosis and enable continuation of the expansion procedure.
Patients undergoing soft tissue expansion treatment for resurfacing skin lesions including scars and nevi that required therapeutic intervention due to early complication signs were included in this study. Patients were randomly divided into treatment group using autologous fat grafting and control group with discontinued expansion and expectant management. The treatment group received autologous fat transfer to the expanded skin.
- Being tested
- Fat grafting
- Keywords
- Fat grafting, Expansion-related complications
- Medical subject headings
- Cicatrix, Nevus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fat graftingProcedure or surgery
In the experimental group, liposuction will be performed and autologous fat graft will be harvest after washing with saline. Patients will receive autologous fat graft transplantation subdermally to expanded skin.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Fat grafting | Experimental | Autologous fat graft transplantation subdermally to expanded skin. Receives: Procedure: Fat grafting |
| Control | No intervention | Expansion was discontinued until the early signs of complication disappeared. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Measure the Change in Expansion Volume
Record the volume(ml) of each expander
Measured: Change from baseline volume at 12 weeks
To Measure the Change in Skin Thickness
Record the thickness of the expanded skin(cm) by ultrasound scanning
Measured: Change from baseline skin thickness at 12 weeks
Secondary outcomes (2)
To Measure the Texture of Expanded Flap with VISIA scanner
Evaluate skin texture with VISIA scanner and compare the characteristics
Measured: baseline and 12 weeks post treatment
Occurence of Major Adverse Events
Including expanded flap ischaemia, necrosis, fluidify, infection, and all other adverse events
Measured: Up to approximately 12 weeks after study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startJan 2011
- Primary completionMar 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qing-FengLi Li,MD, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02809001
- Sponsor's protocol ID
- Shanghai9PH
- Status last verified
- Jun 2016
- First submitted
- 5 Jun 2016
- Last updated
- 22 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Autologous Fat Transfer on Preventing Expanded Skin From Expansion Failure
- ClinicalTrials.gov ID
- NCT02809001
- Acronym / sponsor ID
- Shanghai9PH
- Keywords
- Fat grafting, Expansion-related complications
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Mar 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 22 Jun 2016 (estimated)
- 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 evaluate whether autologous fat grafting is safe and/or effective to prevent expanded skin from expansion failure.
Detailed description
The repair of skin defects is a common problem for reconstructive surgeons.Soft tissue expansion is a widely used technique for the repair of skin defects. Early expansion-related complications such as skin thinning, telangiectasia, and striae may result in expansion failure and ultimately jeopardize final outcome. In the past years, discontinuation of the expansion procedure was the only therapeutic option, when early alarm signs such as semitransparent appearance and telangiectasia of the expanded skin were encountered. We aimed to overcome these complications by therapeutic fat grafting to prevent skin necrosis and enable continuation of the expansion procedure.
Patients undergoing soft tissue expansion treatment for resurfacing skin lesions including scars and nevi that required therapeutic intervention due to early complication signs were included in this study. Patients were randomly divided into treatment group using autologous fat grafting and control group with discontinued expansion and expectant management. The treatment group received autologous fat transfer to the expanded skin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Fat grafting | Experimental | Procedure: Fat graftingAutologous fat graft transplantation subdermally to expanded skin. |
| Control | No intervention | –Expansion was discontinued until the early signs of complication disappeared. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Expanding skin donor site at the face, neck, anterior chest wall, abdominal wall or back;
- Implanted silicone expander of 50 to 800 ml in size;
- History of deterioration in the expanded skin texture that did not improve after the inflation procedure was suspended for more than 2 weeks;
- Persistent high level of expander internal pressure;
- Need for further skin expansion;
Key exclusion criteria (10 listed)
- 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;
- Rupture of expanded skin, expander exposure;
- 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 less than 17 or insufficient subcutaneous fat;
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 |
|---|---|---|
| Fat graftingIn the experimental group, liposuction will be performed and autologous fat graft will be harvest after washing with saline. Patients will receive autologous fat graft transplantation subdermally to expanded skin. | Procedure or surgery | Experimental: Fat grafting |
Primary outcome
To Measure the Change in Expansion Volume
Time frame: Change from baseline volume at 12 weeks
Record the volume(ml) of each expander
To Measure the Change in Skin Thickness
Time frame: Change from baseline skin thickness at 12 weeks
Record the thickness of the expanded skin(cm) by ultrasound scanning
2 secondary outcomes
To Measure the Texture of Expanded Flap with VISIA scanner
Time frame: baseline and 12 weeks post treatment
Occurence of Major Adverse Events
Time frame: Up to approximately 12 weeks after study start
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 22 Jun 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fat grafting in people with Scar and Nevus, run by Shanghai Jiao Tong University School of Medicine 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 5 inclusion and 10 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 22 Jun 2016. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To Measure the Change in Expansion Volume (time frame: Change from baseline volume at 12 weeks). The study lists 2 primary outcomes in all. 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 22 Jun 2016.