In-Vivo Assessment of Adipose Allograft Extracellular Matrix in Abdominoplasty Patients (NCT02845180) | Clinical Trial Compass
CompletedNot Applicable
In-Vivo Assessment of Adipose Allograft Extracellular Matrix in Abdominoplasty Patients
United States10 participantsStarted 2016-11
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria
* Scheduled to undergo elective abdominoplasty.
* Able to provide informed consent.
* Able to understand and comply with the study design and are willing to return for all of the research required follow-up visits.
* BMI great than or equal to 23 and less than or equal to 35.
* Thickness of subcutaneous tissue on abdominal wall is at least 2cm thick.
* If a female, must test negative on a urine pregnancy test.
* If a female, must be willing to utilize an acceptable method of birth control (i.e., oral contraceptives, condom with spermicide, etc.) for the duration of the study.
Exclusion Criteria:
* Thickness of subcutaneous tissue on abdominal wall is less than 2cm thick.
* Previous liposuction at intended sites of treatment.
* Actively taking immunosuppressive therapy including systemic steroids (intranasal/inhaled steroids are acceptable).
* Actively receiving chemotherapy or radiation treatment.
* Subjects with a life expectancy of less than 9 months, terminal conditions or factors making follow-up difficult (e.g.; no fixed address, telephone, etc.)
* Subjects with intolerance to additional study-associated drugs/therapies (e.g.; lidocaine, etc.).
* Subjects with known coagulopathy.
* Subjects on chronic anticoagulants (e.g. Coumadin, etc.).
* Subjects who are pregnant, lactating or planning pregnancy during the study period.
* Subjects with abnormal blood chemistry or any abnormal laboratory finding considered clinically significant in that it would d…
What they're measuring
1
Histopathology evaluation for number of mature adipocytes via haematoxylin and eosin staining.