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.
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.
Study Type
OBSERVATIONAL
Enrollment
15
Adipose Allograft Matrix (AAM) injection, Non-dominant wrist
Miami Hand Center
Key Biscayne, Florida, United States
Tribeca Plastic Surgery
New York, New York, United States
2-3mm raised wheal volume retention in dorsal wrist injected with AAM at 16 weeks
Using a volume assessment scale photographs of treated vs. non-treated dorsal wrist will be evaluated by three plastic surgeons, with mean outcomes for each patient documented as final evidence
Time frame: 16 weeks
Sub-Dermal Tissue Analysis
Magnetic resonance imaging taken at pre-injection (Week 0) and at 16 weeks of treated and non treated dorsal wrists will be evaluated by an independent radiologist for sub dermal adipose persistence
Time frame: 16 weeks
Local skin changes
via clinical observation and photographic evidence taken at pre-injection and at pre and post week 0, 2,10 and 16 weeks of treated and non treated dorsal wrists. local skin changes such as pore size, redness, swelling will be documented by study surgeon
Time frame: 16 weeks
Volume retention during the study interim period, documented at weeks 2 and 10
Using a volume assessment scale, photographs of treated vs. non-treated dorsal wrist will be evaluated by three plastic surgeons, using data collected at interim time points during the study; specifically, week 2 and week 10
Time frame: 8 weeks
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