Autologous Fat Transfer for Scar Prevention and Remodeling
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Wound
In brief
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.
Key facts
- Study ID
- NCT01119326
- Run by
- University of Florida
- People needed
- 14
- Starts
- 2010-04-01
- Expected to finish
- 2017-06-01
- Last updated by the study team
- 2017-07-21
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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:
- 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.
You may not qualify if…
- Sepsis
- Life or limb-threatening injury/disease
- Prior history of non-compliance
- Active drug use/abuse
- Active psychiatric illness
- Pregnancy
- 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)
Where it is running
- University of Florida — Gainesville, Florida, United States
- Institute of Surgical Research (ISR)/Brooke Army Medical Center (BAMC) — Fort Sam Houston, Texas, United States
- University of Virginia — Charlottesville, Virginia, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.