ScarNCT03406143
Evaluation of the Effect of CGF in Promoting Mechanical-stretch Induced in Vivo Skin Regeneration
A study testing CGF injection in people with Scar, run by Shanghai Jiao Tong University School of Medicine at 2 sites in China.
Trial summary
The purpose of this study is to evaluating whether autologous Concentrate Growth Factors(CGF) is safe and/or effective to accelerating skin regeneration and soft tissue expansion. Read more about this study
- Who is it for?
- Ages 14 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Scar
- What is being tested?
- CGF injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 2 sitesChina
- Study dates
- 1 Sep 2016to 31 Aug 2019
- 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 14 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age of 14 to 65 years;
- Expanding skin donor site at the face, neck, anterior chest wall, abdominal wall or back;
- Persistent high level of expander internal pressure;
- Need for further skin expansion;
Who cannot join
- • 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;
- History of any hematological disease, including leukopenia , thrombocytopenia, or thrombocytosis;
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- History of allogenic bone marrow transplantation;
- Long history of smoking;
- Evidence of malignant diseases or unwillingness to participate.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200011
Li Qing Feng, MD; PhD, 0086 21 63089567, dr.liqingfeng@yahoo.com
Chen Cheng, MD, 0086 21 13621925833, shno9hospital@163.com
- Recruiting
Shanghai Ninth People's Hospital
Shanghai
Qing-Feng Li, M.D., Ph.D., 86 21 23271699
About this study
Official title: Evaluation of the Effect of CGF in Promoting Mechanical-stretch Induced in Vivo Skin
The purpose of this study is to evaluating whether autologous Concentrate Growth Factors(CGF) is safe and/or effective to accelerating skin regeneration and soft tissue expansion.
- Conditions
- Scar
- Being tested
- CGF injection, Control
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGF injectionProcedure or surgery
CGF injection subdermally to expanded skin at the density of 0.02ml/cm2.
ControlProcedure or surgery
Saline will be injected into expanded skin
| Study group | Role | What they receive |
|---|---|---|
| CGF injection group | Experimental | Concentrate Growth Factors(CGF) will be harvested through centrifugation afte intravenous blood collection. Venous blood was collected in tube and then centrifuged in Medifuge system（Thermo Scientific）. About 2ml liquid CGF can be harvested from 9ml venous blood. Patients will receive autologous CGF injection subdermally to expanded skin at the density of 0.02 ml/cm2. Receives: Procedure: CGF injection |
| Control group | Sham comparator | 0.9% saline will be injected into expanded skin for control study. Patients will receive saline injection subdermally to expanded skin at the density of 0.02 ml/cm2. Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Measure the Change in Inflation Volume of the Silicone Expander From Baseline at 8 Weeks
Record the inflation volume(ml) of each expander with the maintained inner pressure. The inflation volume was recorded according to the injection volume during expansion.
Measured: baseline and 8 weeks post treatment
Secondary outcomes (2)
To Measure the Texture of Expanded Flap With Canfield's Visia Scanner
Evaluate skin texture with Canfield's Visia skin analysis imaging system and compare the characteristics including RBX red, RBX brown, pores, spots, et al.
Measured: baseline and 8 weeks post treatment
Occurence of Major Adverse Events
Including expanded flap ischaemia, necrosis, fluidify, infection, and all other adverse events
Measured: Up to approximately 24 months 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 posted23 Jan 2018
- Study start1 Sep 2016
- Primary completion31 Aug 2019 (estimated)
- Study completion31 Aug 2019 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 26 participants (estimated)
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
- NCT03406143
- Sponsor's protocol ID
- CGFskin
- Status last verified
- Jan 2018
- First submitted
- 19 Dec 2017
- Last updated
- 23 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of CGF in Promoting Mechanical-stretch Induced in Vivo Skin
- ClinicalTrials.gov ID
- NCT03406143
- Acronym / sponsor ID
- CGFskin
- Conditions
- Scar
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 31 Aug 2019 (estimated)
- Study completion
- 31 Aug 2019 (estimated)
- First posted
- 23 Jan 2018 (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 evaluating whether autologous Concentrate Growth Factors(CGF) is safe and/or effective to accelerating skin regeneration and soft tissue expansion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGF injection group | Experimental | Procedure: CGF injectionConcentrate Growth Factors(CGF) will be harvested through centrifugation afte intravenous blood collection. Venous blood was collected in tube and then centrifuged in Medifuge system（Thermo Scientific）. About 2ml liquid CGF can be harvested from 9ml venous blood. Patients will receive autologous CGF injection subdermally to expanded skin at the density of 0.02 ml/cm2. |
| Control group | Sham comparator | Procedure: Control0.9% saline will be injected into expanded skin for control study. Patients will receive saline injection subdermally to expanded skin at the density of 0.02 ml/cm2. |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age of 14 to 65 years;
- Expanding skin donor site at the face, neck, anterior chest wall, abdominal wall or back;
- Persistent high level of expander internal pressure;
- Need for further skin expansion;
Key exclusion criteria (9 listed)
- • Not fit for soft tissue expansion treatment;
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 |
|---|---|---|
| CGF injectionCGF injection subdermally to expanded skin at the density of 0.02ml/cm2. | Procedure or surgery | CGF injection group |
| ControlSaline will be injected into expanded skin | Procedure or surgery | Control group |
Primary outcome
To Measure the Change in Inflation Volume of the Silicone Expander From Baseline at 8 Weeks
Time frame: baseline and 8 weeks post treatment
Record the inflation volume(ml) of each expander with the maintained inner pressure. The inflation volume was recorded according to the injection volume during expansion.
2 secondary outcomes
To Measure the Texture of Expanded Flap With Canfield's Visia Scanner
Time frame: baseline and 8 weeks post treatment
Occurence of Major Adverse Events
Time frame: Up to approximately 24 months after study start
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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.
Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CGF injection in people with Scar, run by Shanghai Jiao Tong University School of Medicine at 2 sites 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 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: status not confirmed, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Measure the Change in Inflation Volume of the Silicone Expander From Baseline at 8 Weeks (time frame: baseline and 8 weeks post treatment). 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 23 Jan 2018.