Autologous Fat Transfer for Scar Prevention and Remodeling
Condition: Wound
Study type: Interventional
Phase: Phase 1/Phase 2

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). 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.
    

Intervention name(s): Autologous Fat Transfer
Intervention type(s): Procedure
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: scar prevention; healing; tissue; AFT; scar analysis