Mastopexy
Conditions
Brief summary
The purpose of this study is to evaluate the clinical performance of SERI® Surgical Scaffold to maintain the size of the areola by providing additional soft tissue support after circumferential periareolar mastopexy.
Interventions
DEVICEsilk surgical scaffold
surgical implant
Sponsors
Allergan
Mark Mofid MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female, age 18 years or older desiring a reduction in size of nipple areola complex * Be in good health and suited to general anesthesia and planned treatments * Non smokers * If the subject is of childbearing potential, have a urine pregnancy test evaluated as negative (assessed at baseline examination (Visit 1), agree to use contraception as prevention to avoid pregnancy during the study period * Previous augmentation with silicone-filled or saline-filled breast implants or patients desiring periareolar mastopexy * Requiring surgery for ptotic breasts
Exclusion criteria
* BMI (Body Mass Index) that is ≥ 30 kg/m2 * Active smoker or have smoked within 6 weeks prior to screening/qualification visit (Visit 1) * Pregnant or nursing * Advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy * Previous mastectomy or lumpectomy * Abscess or infection in the body at the time of enrollment * Had any disease, including uncontrolled diabetes (e.g., HbAIc \> 8%), that is clinically known to impact wound healing ability. For example: collagen-vascular, connective tissue or autoimmune disorders (e.g., Systemic Lupus, Rheumatoid Arthritis, Scleroderma) * Subjects with diagnosed diabetes must have HbAIc ≤ 8% within 3 months of enrollment * Is taking medications known to impair wound healing (e.g. corticosteroids, chemotherapeutic agents etc.,) * Bleeding disorders (e.g., Hemophilia, von Willebrand Disease) including the following medications & supplements: Warfarin, platelet inhibitors (e.g. NSAIDs or Clopidogrel) not stopped within 2 weeks of the operation and herbal supplements known to predispose to bleeding (e.g. Gingko and Ginseng) * Showed tissue characteristics that were clinically incompatible with mammaplasty, such as tissue damage resulting from radiation, inadequate tissue, compromised vascularity or ulceration * Had, or was under treatment for, any condition that may have constituted an unwarranted surgical risk (e.g., unstable cardiac or pulmonary problems) * History of prior implantation of any surgical scaffold (e.g., synthetic mesh, acellular dermal matrix, or biologic mesh) in the breast * Implantation of any non-SERI® surgical scaffold (e.g., synthetic mesh, acellular dermal matrix, or biologic mesh) during the study period * Be currently enrolled in another clinical study of an implanted device in the breast or plan to enroll in another clinical study within the study period, which could affect wound healing in the breast repair site and/or would not allow the patient to attend all study visits as outlined within this protocol * Product contraindications for use of SERI® Surgical Scaffold per the supplied package insert (e.g., hypersensitivity to silk) * Show psychological characteristics that may have been incompatible with the surgical procedure and the prosthesis, such as inappropriate attitude or motivation (e.g., body dysmorphic disorder) * Active alcohol/substance abuse problem or have had a relapse within 1 year prior to screening/qualification visit (Visit 1) * Was not willing to undergo further surgery for revision, if medically required
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Areolar Dilation of up to 6mm at 12 Months | 12 months after SERI implantation | areolar dilation of up to 6mm |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SERI Subjects receiving SERI for mastopexy
silk surgical scaffold: surgical implant | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | SERI | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 13 Participants | — |
| Age, Continuous | 32.85 Years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 13 Participants | — |
| Sex: Female, Male Female | 13 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
Primary
Number of Participants With Areolar Dilation of up to 6mm at 12 Months
areolar dilation of up to 6mm
Time frame: 12 months after SERI implantation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SERI | Number of Participants With Areolar Dilation of up to 6mm at 12 Months | 13 Participants |