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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
10
Injection followed by surgery
University of Pittsburgh
Philadelphia, Pennsylvania, United States
Histopathology evaluation for number of mature adipocytes via haematoxylin and eosin staining.
Change from baseline to 6 months in abdominal tissue samples using H \& E staining
Time frame: 6 months
Safety of allograft adipose matrix (AAM) injections as determined by the incidence of adverse events.
Ongoing analysis of adverse events collected for the duration of a subject's participation and ongoing aggregate analysis of all subjects' adverse events. These endpoints will not be tested statistically unless unusual or unexpected results are obtained.
Time frame: 6 months
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