Allograft Adipose Matrix (AAM) in Subcutaneous Dorsal Wrist

NCT02445118 | Completed

• 1 other identifier: MTF 184N
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

adipose, allograft

Outcome Measures

Primary Outcomes (1)

• 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

  16 weeks

Secondary Outcomes (3)

• Sub-Dermal Tissue Analysis

  16 weeks

• Local skin changes

  16 weeks

• Volume retention during the study interim period, documented at weeks 2 and 10

  8 weeks

Study Arms (1)

Adipose Allograft Matrix Injection

AAM injected to create a 2 to 3mm raised wheal on the proximal dorsal wrist of the non-dominant hand

Other: Adipose Allograft Matrix (AAM) injection

Interventions

Adipose Allograft Matrix (AAM) injection OTHER

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

Adipose Allograft Matrix Injection

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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)

Sponsors & Collaborators

• Musculoskeletal Transplant Foundation: lead

Study Sites (2)

Miami Hand Center

Key Biscayne, Florida, 33149, United States

Location

Tribeca Plastic Surgery

New York, New York, 10013, United States

Location

Related Publications (1)

• Kokai LE, Schilling BK, Chnari E, Huang YC, Imming EA, Karunamurthy A, Khouri RK, D'Amico RA, Coleman SR, Marra KG, Rubin JP. Injectable Allograft Adipose Matrix Supports Adipogenic Tissue Remodeling in the Nude Mouse and Human. Plast Reconstr Surg. 2019 Feb;143(2):299e-309e. doi: 10.1097/PRS.0000000000005269.

  PMID: 30688888 DERIVED

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Sydney R. Coleman, MD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

• Roger K Khouri, MD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2015
• First Posted: May 15, 2015
• Study Start: May 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: August 10, 2016

Record last verified: 2015-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)