SERI® Surgical Scaffold for Soft Tissue Support in Revision Augmentation Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 34
- Locations
- 10
- Primary Endpoint
- Reoperation Rate (Per Implanted Breast) for the Presenting Condition at 12 Months.
Study Overview
Brief Summary
An evaluation of the clinical performance of SERI® Surgical Scaffold for soft tissue support in subjects undergoing revision augmentation surgery for increased nipple to inframammary fold distance.
Detailed Description
This is a single arm prospective study. Approximately 4 investigational sites will enroll and follow subjects who meet the study criteria.The study will span a total of approximately 18 months: an estimated 6 months for recruitment and 12 months for follow up. 50 subjects will be enrolled in the study. It is anticipated that given an average of 1.5 operated breasts per subject enrolled for Revision Augmentation surgery that 75 implantations of SERI® surgical scaffold will occur.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Negative nicotine test at screening visit
- •Previous augmentation with silicone-filled or saline-filled breast implants requiring Revision Augmentation surgery for increased nipple:inframammary fold distance
- •Well vascularized skin flaps that can be approximated without tension
Exclusion Criteria
- •BMI (Body Mass Index) that is ≥ 30 kg/m2
- •Active smoker or have smoked within 6 weeks prior to screening visit
- •Pregnant or nursing
- •Advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy
- •Carcinoma of the breast
- •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
- •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
- •Product contraindications for use of SERI® Surgical Scaffold per the supplied package insert (e.g., hypersensitivity to silk)
Outcomes
Primary Outcomes
Reoperation Rate (Per Implanted Breast) for the Presenting Condition at 12 Months.
Time Frame: 12 months
This refers to the proportion of implanted breasts that will require reoperation for the recurrence of the initial cause of the increase in nipple to inframammary fold distance at the end of the 12-month follow-up period. Reoperation rate outcomes are presented as number of implanted breasts that required a reoperation out of the overall number of units analyzed.
Secondary Outcomes
- Reoperation Rate (Per Implanted Breast) for Any Cause at 12 Months(12 months)
- AE Incidence Rates (Per Implanted Breast) at 30 Days(30 days)
- AE Incidence Rates (Per Implanted Breast) at 12 Months(12 months)
- Change in Mammometry From Baseline to 12 Months (Per Implanted Breast)(12 months)
- Difference in Mean Scores From Baseline to 12 Months Across 4 Scales of the BREAST Q (Per Patient)(12 months)