NCT02845180

In-Vivo Assessment of Adipose Allograft Extracellular Matrix in Abdominoplasty Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Musculoskeletal Transplant Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess local tissue reaction and retention of an adipose allograft extracellular matrix at 3 or 6 months post-injection into the subcutaneous abdominal tissue of healthy volunteers scheduled to undergo elective panniculectomy.

Detailed description

This is a prospective, randomized, two arm, single center study to assess adipose tissue development and retention when an implantable allograft adipose matrix ('AAM') is injected in the abdominal subcutaneous tissue of healthy volunteers undergoing elective standard-of-care panniculectomy. This study will enroll ten (10) subjects. These subjects will be randomized to one of two study arms. Arm 1 will consist of five (5) subjects who will receive injections of AAM to be followed clinically for three (3) months duration, and arm 2 will consist of five (5) subjects who will receive injections of AAM to be followed clinically for six (6) months duration. At the point of completion of each arm, 3 or 6 months, the injected tissue will be surgically removed as part of the panniculectomy procedure. Samples of the AAM injected tissue areas and surrounding tissue will be obtained and processed for histologic evaluation.

Conditions

• Obesity

Interventions

Type	Name	Description
PROCEDURE	Adipose Allograft Extracellular Matrix (AAM) Injection	Injection followed by surgery

Timeline

• Start date: 2016-11-01
• Primary completion: 2018-06-15
• Completion: 2018-06-15
• First posted: 2016-07-27
• Last updated: 2018-09-19

Locations

1 site across 1 country: United States