Circumferential Periareolar Mastopexy Using SERI Surgical Scaffold

Study Overview
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Brief Summary
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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.

Official Title
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Circumferential Periareolar Mastopexy Using SERI Surgical Scaffold

Conditions
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Mastopexy

Intervention / Treatment
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* Device: silk surgical scaffold


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SERI<br>Subjects receiving SERI for mastopexy | Device: silk surgical scaffold<br>* surgical implant<br>* Other names: SERI surgical scaffold;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Areolar Dilation of up to 6mm at 12 Months | areolar dilation of up to 6mm | 12 months after SERI implantation |