Autologous Fat Transfer for Scar Prevention and Remodeling

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Florida
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01119326
First received: April 27, 2010
Last updated: February 28, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Wound
Procedure: Autologous Fat Transfer
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Autologous Fat Transfer for Scar Prevention and Remodeling

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • To determine the correlation of subjective and objective scar assessment tools for serial, prospective scar analysis. [ Time Frame: 4 times for a year ] [ Designated as safety issue: No ]

Estimated Enrollment: 57
Study Start Date: April 2010
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo procedure
Procedure: Autologous Fat Transfer
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.
Experimental: Autologous Fat Transfer (AFT) group
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
Procedure: Autologous Fat Transfer
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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

  2. Adequate adipose depot for tissue harvest
  3. 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)

  4. Age range: 18-65 years
  5. Negative pregnancy test
  6. Able and willing to provide verbal and written informed consent.
  7. Subject should begin protocol initiation within 2 weeks of being enrolled.

Exclusion Criteria:

  1. Sepsis
  2. Life or limb-threatening injury/disease
  3. Prior history of non-compliance
  4. Active drug use/abuse
  5. Active psychiatric illness
  6. Pregnancy
  7. 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.
  8. History of bleeding tendency/inability to clot, and/or International normalized ratio(INR) ≥ 2.2
  9. Life-threatening allergic reaction to one of the medications/agents to be used in the study with no acceptable alternative/substitute identifiable
  10. Use of steroid injections, pressure garments, silicone sheeting or other similar scar management modalities and cannot be discontinued during study participation.
  11. Incarceration.
  12. Active duty military personnel (at UF site only)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01119326

Contacts
Contact: Justine M Pierson, BS 352.273.9193 justine.pierson@surgery.ufl.edu

Locations
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Justine M Pierson, BS    352-273-9193    justine.pierson@surgery.ufl.edu   
Principal Investigator: Adam Katz, MD         
United States, Texas
Institute of Surgical Research (ISR)/Brooke Army Medical Center (BAMC) Recruiting
Fort Sam Houston, Texas, United States, 78234
Contact: Gale E Mankoff, RN    210-919-6316    gale.mankoff@us.army.mil   
Contact: Victoria Hatem, LVN    210-916-6152    victoria.d.hatem.civ@mail.mil   
Principal Investigator: Rodney Chan, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Catherine Ratliff, PhD    434-924-5088    crr9m@hscmail.mcc.virginia.edu   
Principal Investigator: David B Drake, MD         
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Adam Katz, MD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01119326     History of Changes
Other Study ID Numbers: 503-2012
Study First Received: April 27, 2010
Last Updated: February 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
scar prevention
healing
tissue
AFT
scar analysis

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014