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

Completed · Not applicable

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT02845180

Run by

Musculoskeletal Transplant Foundation

People needed

10

Starts

2016-11-01

Expected to finish

2018-06-15

Last updated by the study team

2018-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 deem the subject inappropriate for surgical procedures, as determined by the Investigator (i.e., CBC with Differential, platelets, comprehensive metabolic panel to include electrolytes, bun/creatinine, liver function test and coagulation tests).
• Subjects who have, as determined by the investigator, a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study (e.g.; Type I and II diabetic patients).
• Subjects with known alcohol or narcotic drug dependency that is deemed to impact compliance.
• Subjects with diagnosed autoimmune disorders known to affect wound healing, such as Systemic Lupus Erythematosis (SLE), psoriasis, infection and inflammation (seborrheic dermatitis).
• Subjects currently enrolled in another investigational study.
• Study Population Description: Patients scheduled to undergo elective abdominoplasty Sampling Method: Invitation to volunteer

Where it is running

• University of Pittsburgh — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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