Allograft Adipose Matrix (AAM) in Subcutaneous Dorsal Wrist
Condition: Aesthetic Rejuvenation
Study type: Observational

Summary: 
      This is a 16 week pilot study to assess short term outcomes of an injectable allograft
      adipose matrix (AAM) in the subcutaneous space in the dorsum of the wrist. A total of 30
      patients will be enrolled at 2 sites and will be followed for sixteen weeks. Volume retention
      and local skin changes will be observed and documented prior to and following injection at
      week 0 and at follow up visits at 2, 10 and 16 weeks. Evaluations will be done via
      photographic analysis at week 0,2,10 and 16 weeks and half of the patients will undergo
      magnetic resonance imaging at week zero and at week 16. The dominant wrist will serve as a
      control and will receive no injection. Analysis includes volume retention, tissue analysis,
      local skin changes and adverse events, if any.
    

Detailed description: 
      This pilot study focuses on three primary objectives: to evaluate volume retention at the
      site of injected allograft adipose matrix (AAM), to obtain tissue analysis via magnetic
      resonance imaging at the site of injection and to evaluate local skin changes as a result of
      the injection of AAM with follow up over a 16 week period. The AAM is derived from cadaveric
      human adipose recovered, processed, dehydrated and distributed by the study sponsor from
      thoroughly screened donors. It is distributed with instructions for rehydration prior to
      single use. The injection site (non-dominant wrist) will be infiltrated with Lidocaine 0.5%,
      Epinepherine 1:200,000 prior to AAM injection. Volume of AAM necessary to create a centered
      2-3mm raised wheal at the first proximal dorsal wrist crease will be administered.
      Photographs taken prior and following the injection and at each of the subsequent visits are
      taken with a color standard within the frame for later color change analysis of the injection
      surrounding area. Both the control and treated hand/wrist will be photographed separately in
      numerous positions (extension, flexion and several degrees of either) at heart level, at week
      0,2,10 and 16 weeks. A clinical assessment scale for evaluation of skin changes in appearance
      will also be done at these same times. Patients will be advised to avoid prolonged pressure
      to the dorsal wrists, wear no jewelry or wrist bands, etc., for the duration of their
      participation in the study. Those patients designated for MR imaging shall have their MRIs
      done within 3 to 5 days of their week zero and week16 visits. The images shall be read and
      documented by a single independent radiologist.
    

Intervention name(s): Adipose Allograft Matrix (AAM) injection
Intervention type(s): Other
Intervention description(s): Adipose Allograft Matrix (AAM) injection, Non-dominant wrist
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Non-smoking females between 45 and 65 years of age with a BMI <30, with well controlled
        blood pressure, no active infections, collagen disorders,vascular diseases, history of
        lymphedema, mastectomy, lymph node dissection, end stage organ failure such as COPD, CRF,
        or CHF, and who have not undergone deep chemical peels, laser, Ultherapy, Thermage or other
        light or energy based procedures to the dorsum of the hands within the past year.
      
Keywords: adipose, allograft