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Allograft Adipose Matrix (AAM) in Subcutaneous Dorsal Wrist

NCT02445118 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2016-08-10

No results posted yet for this study

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.

Conditions

  • Aesthetic Rejuvenation

Interventions

OTHER

Adipose Allograft Matrix (AAM) injection

Adipose Allograft Matrix (AAM) injection, Non-dominant wrist

Sponsors & Collaborators

  • Musculoskeletal Transplant Foundation

    lead OTHER

Principal Investigators

  • Sydney R. Coleman, MD · Study Principal Investigator

  • Roger K Khouri, MD · Study Principal Investigator

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02445118 on ClinicalTrials.gov