Breast Reconstruction and Augmentation With Brava Enhanced Autologous Fat Micro Grafting (NCT00466765) | Clinical Trial Compass
CompletedNot Applicable
Breast Reconstruction and Augmentation With Brava Enhanced Autologous Fat Micro Grafting
United States589 participantsStarted 2010-01
Plain-language summary
The primary objectives of this study is to determine whether use of a negative pressure external soft-tissue expansion system pre-operatively and post-operatively improves and secures graft survival in autologous fat micro grafting breast augmentation and reconstruction procedures.
Who can participate
Age range18 Years – 80 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Female volunteers between the ages of 18 and 80 years of age and weighing between 100- 275 lbs may be enrolled in the study. Ages 16 to 18 with developmental deformities may be enrolled with parental consent.
* Post implant removal with subcutaneous defect
* Post lumpectomy patients with or without radiation therapy with asymmetrical defect
* Post mastectomy with or without radiation therapy
* Post flap reconstruction with asymmetry or contour defect
* Primary breast augmentation
* Primary Post-mastectomy breast reconstruction
* Breast asymmetry
* Other congenital malformation of the breast such as constricted breasts, tubular breast, tuberous breasts, pectus associated deformities and Poland's Syndrome
Exclusion Criteria:
The following volunteers must be excluded from the study:
* A volunteer who has a positive pregnancy test
* A volunteer who has a pacemaker or aneurysm clips
* A volunteer who has had a cardiac stent placed within the last two months
* A volunteer who is claustrophobic
* A volunteer with a known, current substance abuse
* A volunteer with a history of silicone allergy
* A volunteer with a history of Gadolinium allergy (if MRI performed)
* A volunteer with a history of Lidocaine allergy
* A volunteer with a bleeding diathesis
* Untreated breast cancer
* A volunteer who smokes cigarettes or who has a history of smoking within the past three (3) months.
* Medical Conditions including Sever Hypertension, Renal disease, steroid dependant…
What they're measuring
1
Digital photographic interpretation by Board Certified Plastic Surgeon or Radiologist.