WoundPhase 1/2NCT01119326
Autologous Fat Transfer for Scar Prevention and Remodeling
A Phase 1/2 study testing Autologous Fat Transfer in people with Wound, run by University of Florida at 3 sites in United States.
Trial summary
The purpose of this research study is to find out if it is safe and feasible to improve the appearance and quality of a scar by using a procedure in which adipose tissue (fat) is taken from other parts of your body and injected, or transplanted into a scar. This procedure is called autologous fat transfer (AFT). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Wound
- What is being tested?
- Autologous Fat Transfer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2010to Jun 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 2 separate (i.e. non-contiguous) wounds/scars previously healed by placement of a STSG and/or by secondary intention ("study sites"), each ≤ 50cm2 in size (area).
- o The study sites should be similar in size and anatomical location (e.g. upper arms; trunk; legs) to the extent practically possible
- Adequate adipose depot for tissue harvest
- For Early AFT Subgroup:
- o medically stable such that study sites are amenable to AFT within 2-4 weeks after definitive closure(STSG) or healing (secondary closure)
- For Delayed AFT Subgroup:
Show all 11Show fewer
- o medically stable such that study sites are amenable to AFT at least 6 months after definitive closure(STSG) or healing (secondary closure)
- Age range: 18-65 years
- Negative pregnancy test
- Able and willing to provide verbal and written informed consent.
- Subject should begin protocol initiation within 2 weeks of being enrolled.
Who cannot join
- Sepsis
- Life or limb-threatening injury/disease
- Prior history of non-compliance
- Active drug use/abuse
- Active psychiatric illness
- Pregnancy
Show all 12Show fewer
- Active cancer, or new diagnosis of cancer within the past 5 years, with the exception of basal cell and squamous cell carcinomas, as long as the subject is disease free at the time of enrollment and that the previous diagnosis was not at a site to be treated by AFT.
- History of bleeding tendency/inability to clot, and/or International normalized ratio(INR) ≥ 2.2
- Life-threatening allergic reaction to one of the medications/agents to be used in the study with no acceptable alternative/substitute identifiable
- Use of steroid injections, pressure garments, silicone sheeting or other similar scar management modalities and cannot be discontinued during study participation.
- Incarceration.
- Active duty military personnel (at UF site only)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Virginia
Charlottesville, Virginia, 22908
Institute of Surgical Research (ISR)/Brooke Army Medical Center (BAMC)
Fort Sam Houston, Texas, 78234
University of Florida
Gainesville, Florida, 32610
About this study
Official title: A Phase I/II Study of Autologous Fat Transfer for Scar Prevention and Remodeling
The purpose of this research study is to find out if it is safe and feasible to improve the appearance and quality of a scar by using a procedure in which adipose tissue (fat) is taken from other parts of your body and injected, or transplanted into a scar. This procedure is called autologous fat transfer (AFT). The main goal of this study is to see if AFT is safe and can improve the quality and appearance of scar tissue. Another main goal is to determine how much tissue should be transplanted to get the best results.
Read the detailed description
Before you begin study treatment, you will have the following tests and procedures:
- A physical examination
- A review of your medical history. You will be asked about any history of psychiatric illness.
- You will be asked about any medications you might be currently taking. In addition, you will be asked about alcohol and drug use.
- Pregnancy test, if you are a woman of childbearing potential.
- Digital photography of the treatment sites.
- Scar assessment - you will be asked to complete a quick and simple questionnaire about the appearance of your scars and how well they are healing/have healed.
- Passive and Active range of motion assessment (P/AROM) - If your study scars extend over a joint such as the elbow, or a finger knuckle, you will be tested to see how well you can move or bend the joint before and after the study treatment.
- After screening, but prior to AFT procedure, you may need to undergo additional tests. These tests may include further laboratory assessments, a chest x-ray, or electrocardiogram (ECG). The requirement for the additional testing is largely depending on your age, recent surgical or medical history, or a medical condition indicating the need for these tests.
- Outpatient surgery procedure that will include anesthesia that puts you to sleep (either with or without a breathing tube), medicines given through an IV (into your veins), and/or local numbing medicine, such as lidocaine. You will receive ALL of the usual standard monitoring, medications, safety precautions, and care that is provided for any patient undergoing any surgery, including antibiotics as needed, pain medicine as needed (during and after your procedure) and other supportive care as needed.
- You will have 2 treatment sites identified for AFT in this study. Under anesthesia, you will have skin biopsies for research purposes only taken prior to study procedures from each designated treatment area. Both treatment sites will be similar in size and location on your body. One of these sites will be treated using the AFT procedure; the other will be treated using a fake procedure (placebo procedure).
- The surgeon will remove fat tissue from under you skin using standard liposuction methods.
- This tissue will be washed and concentrated to remove unwanted fluids and medicines and then injected under the designated skin grafts/scars using a small needle.
- There will be follow-up visits done 1 week, 1 month, 3 months, 6 months, and 12 months after the AFT procedure to perform the following tests and procedures:
- A physical examination
- A review of your medical history
- You will be asked about any medications you might be currently taking
- Digital photography of the treatment sites.
- Scar assessment - you will be asked to complete a questionnaire about the appearance of your scars and how well they are healing.
- Active range of motion assessment (AROM) - If your site spans a joint, you will be tested to see how well you can move the joint.
- As part of this research study, two skin biopsies will be taken from each study site (at time of treatment, 6 months, and 12 months after AFT procedure only). A skin biopsy is a routine procedure which involves obtaining a very small skin sample (2-4 mm) with a special instrument (punch biopsy) that cuts out a small circular piece of skin. If needed, the area where the biopsy was taken may be closed with stitches.
- Conditions
- Wound
- Being tested
- Autologous Fat Transfer
- Keywords
- scar prevention, healing, tissue, AFT, scar analysis
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Fat TransferProcedure or surgery
one site will be treated with AFT For placebo treated (control) sites, an equal number of empty cannula passes will be administered using a similar technique described for the AFT.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo procedure Receives: Procedure: Autologous Fat Transfer |
| Autologous Fat Transfer (AFT) group | Experimental | Subjects will be registered in the context of either the Early AFT subgroup, or the Delayed AFT subgroup based on the timing of their wound closure: early AFT subgroup will contain subjects who are medically stable such that study sites are amenable to AFT within 2-4 weeks of definitive closure (STSG) or healing (secondary closure) and the delayed AFT subgroup will contain subjects who are medically stable such that study sites are amenable to AFT within 6 months or more of definitive closure (STSG) or healing (secondary closure Receives: Procedure: Autologous Fat Transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety and feasibility of using AFT in early and delayed treatment settings to positively enhance the quality and appearance of overlying scar and to determine the safety and impact of AFT "dose" on scar quality and appearance.
If no Dose Limiting Toxicity (DLT) is observed ,dose escalation will occur. Study sites/scars will be delineated by tracings, digital photography,scar assessment scale,and measures of scar elasticity and color. To correlate efficacy with graft quality, a sample of each adipose harvest will be sent to the laboratory for quantitative analysis of the stromal vascular fraction (SVF) with the adipose sample.
Measured: 4 times for a year
Secondary outcomes (1)
To determine the correlation of subjective and objective scar assessment tools for serial, prospective scar analysis.
Measured: 4 times for a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2010 (estimated)
- Study startApr 2010
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Adam Katz, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01119326
- Sponsor's protocol ID
- 503-2012
- Status last verified
- Jul 2017
- First submitted
- 27 Apr 2010
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Autologous Fat Transfer for Scar Prevention and Remodeling
- ClinicalTrials.gov ID
- NCT01119326
- Acronym / sponsor ID
- 503-2012
- Conditions
- Wound
- Keywords
- scar prevention, healing, tissue, AFT, scar analysis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Apr 2010
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 7 May 2010 (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 research study is to find out if it is safe and feasible to improve the appearance and quality of a scar by using a procedure in which adipose tissue (fat) is taken from other parts of your body and injected, or transplanted into a scar. This procedure is called autologous fat transfer (AFT). The main goal of this study is to see if AFT is safe and can improve the quality and appearance of scar tissue. Another main goal is to determine how much tissue should be transplanted to get the best results.
Detailed description
Before you begin study treatment, you will have the following tests and procedures:
- A physical examination
- A review of your medical history. You will be asked about any history of psychiatric illness.
- You will be asked about any medications you might be currently taking. In addition, you will be asked about alcohol and drug use.
- Pregnancy test, if you are a woman of childbearing potential.
- Digital photography of the treatment sites.
- Scar assessment - you will be asked to complete a quick and simple questionnaire about the appearance of your scars and how well they are healing/have healed.
- Passive and Active range of motion assessment (P/AROM) - If your study scars extend over a joint such as the elbow, or a finger knuckle, you will be tested to see how well you can move or bend the joint before and after the study treatment.
- After screening, but prior to AFT procedure, you may need to undergo additional tests. These tests may include further laboratory assessments, a chest x-ray, or electrocardiogram (ECG). The requirement for the additional testing is largely depending on your age, recent surgical or medical history, or a medical condition indicating the need for these tests.
- Outpatient surgery procedure that will include anesthesia that puts you to sleep (either with or without a breathing tube), medicines given through an IV (into your veins), and/or local numbing medicine, such as lidocaine. You will receive ALL of the usual standard monitoring, medications, safety precautions, and care that is provided for any patient undergoing any surgery, including antibiotics as needed, pain medicine as needed (during and after your procedure) and other supportive care as needed.
- You will have 2 treatment sites identified for AFT in this study. Under anesthesia, you will have skin biopsies for research purposes only taken prior to study procedures from each designated treatment area. Both treatment sites will be similar in size and location on your body. One of these sites will be treated using the AFT procedure; the other will be treated using a fake procedure (placebo procedure).
- The surgeon will remove fat tissue from under you skin using standard liposuction methods.
- This tissue will be washed and concentrated to remove unwanted fluids and medicines and then injected under the designated skin grafts/scars using a small needle.
- There will be follow-up visits done 1 week, 1 month, 3 months, 6 months, and 12 months after the AFT procedure to perform the following tests and procedures:
- A physical examination
- A review of your medical history
- You will be asked about any medications you might be currently taking
- Digital photography of the treatment sites.
- Scar assessment - you will be asked to complete a questionnaire about the appearance of your scars and how well they are healing.
- Active range of motion assessment (AROM) - If your site spans a joint, you will be tested to see how well you can move the joint.
- As part of this research study, two skin biopsies will be taken from each study site (at time of treatment, 6 months, and 12 months after AFT procedure only). A skin biopsy is a routine procedure which involves obtaining a very small skin sample (2-4 mm) with a special instrument (punch biopsy) that cuts out a small circular piece of skin. If needed, the area where the biopsy was taken may be closed with stitches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Procedure: Autologous Fat TransferPlacebo procedure |
| Autologous Fat Transfer (AFT) group | Experimental | Procedure: Autologous Fat TransferSubjects will be registered in the context of either the Early AFT subgroup, or the Delayed AFT subgroup based on the timing of their wound closure: early AFT subgroup will contain subjects who are medically stable such that study sites are amenable to AFT within 2-4 weeks of definitive closure (STSG) or healing (secondary closure) and the delayed AFT subgroup will contain subjects who are medically stable such that study sites are amenable to AFT within 6 months or more of definitive closure (STSG) or healing (secondary closure |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- At least 2 separate (i.e. non-contiguous) wounds/scars previously healed by placement of a STSG and/or by secondary intention ("study sites"), each ≤ 50cm2 in size (area).
- o The study sites should be similar in size and anatomical location (e.g. upper arms; trunk; legs) to the extent practically possible
- Adequate adipose depot for tissue harvest
- For Early AFT Subgroup:
- o medically stable such that study sites are amenable to AFT within 2-4 weeks after definitive closure(STSG) or healing (secondary closure)
Key exclusion criteria (12 listed)
- Sepsis
- Life or limb-threatening injury/disease
- Prior history of non-compliance
- Active drug use/abuse
- Active psychiatric illness
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 |
|---|---|---|
| Autologous Fat Transferone site will be treated with AFT For placebo treated (control) sites, an equal number of empty cannula passes will be administered using a similar technique described for the AFT. | Procedure or surgery | Autologous Fat Transfer (AFT) group, Placebo |
Primary outcome
To determine the safety and feasibility of using AFT in early and delayed treatment settings to positively enhance the quality and appearance of overlying scar and to determine the safety and impact of AFT "dose" on scar quality and appearance.
Time frame: 4 times for a year
If no Dose Limiting Toxicity (DLT) is observed ,dose escalation will occur. Study sites/scars will be delineated by tracings, digital photography,scar assessment scale,and measures of scar elasticity and color. To correlate efficacy with graft quality, a sample of each adipose harvest will be sent to the laboratory for quantitative analysis of the stromal vascular fraction (SVF) with the adipose sample.
1 secondary outcome
To determine the correlation of subjective and objective scar assessment tools for serial, prospective scar analysis.
Time frame: 4 times for a year
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 21 Jul 2017.
- Individual participant dataSharing planned: No
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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.
Adam Katz, MD principal investigator
University of Florida
3 sites 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 Autologous Fat Transfer in people with Wound, run by University of Florida at 3 sites in United States.
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 11 inclusion and 12 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 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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.
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 determine the safety and feasibility of using AFT in early and delayed treatment settings to positively enhance the quality and appearance of overlying scar and to determine the safety and impact of AFT "dose" on scar quality and appearance. (time frame: 4 times for a year). 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 Jul 2017.