Allograft Adipose Matrix (AAM) in Subcutaneous Dorsal Wrist

Completed

Conditions studied: Aesthetic Rejuvenation

In brief

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.

Key facts

Study ID

NCT02445118

Run by

Musculoskeletal Transplant Foundation

People needed

15

Starts

2015-05-01

Expected to finish

2016-03-01

Last updated by the study team

2016-08-10

Who can join

Age: 35 and older, up to 75. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Female,
• Between 35 and 75 years of age,
• Well controlled blood pressure,
• Able to sign an informed consent

You may not qualify if…

• Patients with active infection,
• Patients with a body weight change of greater than 5% throughout the 16 weeks of their participation,
• Patients with a BMI of greater than 30,
• Patients with a collagen vascular disease,
• Patients with end-stage organ failure (advanced COPD, CRF, CHF),
• Patients with lymphedema or mastectomy or axillary lymph node dissection, Patients who smoke,
• Patients that have undergone deep chemical peels, lasers, Ultherapy, Thermage, other light or energy based procedures to the dorsum of the hands one year prior,
• Patients who have taken any medication or oral supplements for the previous 4 weeks that could prolong bleeding time (e.g; Aspirin, Plavix, nutritional supplements starting with G, omega-3 , fish oil, etc)

Where it is running

• Miami Hand Center — Key Biscayne, Florida, United States
• Tribeca Plastic Surgery — New York, New York, United States

Full record on ClinicalTrials.gov

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