- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02445118
Allograft Adipose Matrix (AAM) in Subcutaneous Dorsal Wrist
August 9, 2016 updated by: Musculoskeletal Transplant Foundation
Local Skin and Volume Changes With the Use of Allograft Adipose Matrix (AAM) in the Subcutaneous Human Dorsal Wrist, a Pilot Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
15
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Key Biscayne, Florida, United States, 33149
- Miami Hand Center
-
-
New York
-
New York, New York, United States, 10013
- Tribeca Plastic Surgery
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
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.
Description
Inclusion Criteria:
- Female,
- Between 35 and 75 years of age,
- Well controlled blood pressure,
- Able to sign an informed consent
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Adipose Allograft Matrix Injection
AAM injected to create a 2 to 3mm raised wheal on the proximal dorsal wrist of the non-dominant hand
|
Adipose Allograft Matrix (AAM) injection, Non-dominant wrist
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
2-3mm raised wheal volume retention in dorsal wrist injected with AAM at 16 weeks
Time Frame: 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
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sub-Dermal Tissue Analysis
Time Frame: 16 weeks
|
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
|
16 weeks
|
Local skin changes
Time Frame: 16 weeks
|
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
|
16 weeks
|
Volume retention during the study interim period, documented at weeks 2 and 10
Time Frame: 8 weeks
|
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
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sydney R. Coleman, MD, Study Principal Investigator
- Principal Investigator: Roger K Khouri, MD, Study Principal Investigator
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2015
Primary Completion (ACTUAL)
March 1, 2016
Study Completion (ACTUAL)
March 1, 2016
Study Registration Dates
First Submitted
March 25, 2015
First Submitted That Met QC Criteria
May 12, 2015
First Posted (ESTIMATE)
May 15, 2015
Study Record Updates
Last Update Posted (ESTIMATE)
August 10, 2016
Last Update Submitted That Met QC Criteria
August 9, 2016
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MTF 184N
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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