Phase
Condition
Breast Reconstruction
Pressure Ulcer
Treatment
N/AClinical Study ID
Ages > 18 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Female subjects aged 18 years and older
- Female subjects of childbearing potential must have a negative urine or bloodpregnancy test at screening and baseline.
- Female subjects of childbearing potential must agree to use ONE of the following birthcontrol methods throughout the study:
- abstinence
- condom with spermicide
- diaphragm with spermicide
- Hormonal contraceptive
- intra-uterine device Non-childbearing confirmed by prior documentation of at least one of the following:
- postmenopausal
- surgically sterilized
- Subjects undergoing a breast surgery procedure with bilateral anchor incisions
- Signed informed consent form
Exclusion
Exclusion Criteria:
- Subjects with breast implants or history of breast implants
- Subjects undergoing breast surgery requiring breast implants
- Subjects requiring nipple grafting using any technique
- Subjects with a history of infection in the past 6 months in the intended area ofincision
- Subjects with breast tattoos in the intended area of the incision
- Subjects with known skin sensitivity to Tegaderm™
- Subjects with a history of keloids
- Known conditions of collagen vascular diseases
- Subjects with clinically significant medical conditions as determined by theInvestigator, which would impair wound healing including renal, hepatic, hematologic,neurologic or autoimmune disease. Examples include but are not limited to:
- Renal insufficiency as an estimated GFR, which is < 30 mL/min/1.7m2
- Abnormal blood biochemistry defined as 3 times that of the upper limit of thenormal range
- Hepatic insufficiency defined as total bilirubin > 2 mg/dL or serum albumin < 25g/L
- Hemoglobin < 9 g/dL
- Hematocrit < 30%
- Platelet count < 100,000 μL
- Any history within the last 5 years or the presence of any active systemic cancer (with the exception of non-melanoma skin cancer)
- Current treatment with systemic corticosteroids (>15 mg/day). Washout period is 30days prior to screening
- Current treatment with biologic immunosuppressive agents or chemotherapeutic agents.Wash out period for short term immunosuppressive agents is 14 days prior to screening
- Previous history of radiation therapy to the chest
- Known inability to complete required study visits during study participation
- A psychiatric condition (e.g., suicidal ideation), chronic alcohol consumption, ordrug abuse problem determined from the subject's medical history, which, in theopinion of the Investigator, may pose a threat to subject compliance
- Use of any investigational drug or therapy within the 28 days prior to screening
- History of previous breast surgeries in the area where the incisions are to be made
- Currently pregnant, pregnant during the 6 months prior to screening, lactating, orbreastfeeding
- Any other factor, which may, in the opinion of the Investigator, compromiseparticipation and follow-up in the study
- Any areolar abnormalities that are deemed clinically significant by the Investigator
Study Design
Study Description
Connect with a study center
Private Clinic- David Kulber
Los Angeles, California 90048
United StatesSite Not Available
Pasadena Surgeons
Pasadena, California 91105
United StatesSite Not Available
Universal Axon Clinical Research
Doral, Florida 33166
United StatesSite Not Available
University of Florida Health
Gainesville, Florida 32610
United StatesSite Not Available
Miami Plastic Surgery
Miami, Florida 33176
United StatesSite Not Available
Ibrahim H. Amjad, MD, PA
W. Miami, Florida 33144
United StatesSite Not Available
Northwestern University - Feinberg School of Medicine - Division of Plastic & Reconstructive Surgery
Chicago, Illinois 60611
United StatesSite Not Available
Iowa Plastic Surgery
Davenport, Iowa 52807
United StatesSite Not Available
Washington University School of Medicine/Barnes-Jewish Hospital
Saint Louis, Missouri 63130
United StatesSite Not Available
Luxurgery
New York, New York 10021
United StatesSite Not Available
Wake Forest Baptist Hospital - Plastic and Reconstructive Surgery
Winston-Salem, North Carolina 27157
United StatesSite Not Available
Paul Glat, MD PC
Bala-Cynwyd, Pennsylvania 19004
United StatesSite Not Available
Integrated Aesthetics
Spring, Texas 77388
United StatesSite Not Available
University of Utah
Salt Lake City, Utah 84132
United StatesSite Not Available
Washingtonian Plastic Surgery
McLean, Virginia 22102
United StatesSite Not Available
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