Allograft Adipose Matrix (AAM) in Subcutaneous Dorsal Wrist

NCT ID: NCT02445118

Last Updated: 2016-08-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-03-31

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.

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.

Conditions

Aesthetic Rejuvenation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Intervention Type: OTHER

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

Interventions

Adipose Allograft Matrix (AAM) injection

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

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Musculoskeletal Transplant Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sydney R. Coleman, MD

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Roger K Khouri, MD

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

Miami Hand Center

Key Biscayne, Florida, United States

Tribeca Plastic Surgery

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30688888 (View on PubMed)

Other Identifiers

MTF 184N

Identifier Type: -

Identifier Source: org_study_id