SERI® Surgical Scaffold for Soft Tissue Support in Revision Augmentation Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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SERI® Surgical Scaffold for Soft Tissue Support in Revision Augmentation Surgery

Conditions
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Subjects Requiring Revision Breast Augmentation Surgery

Intervention / Treatment
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* Device: SERI® Surgical Scaffold


Participation Criteria
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Eligibility Criteria
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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)

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® scaffold implanted breasts<br>SERI® Surgical Scaffold is a knitted, multifilament, bioengineered, silk mesh. It is mechanically strong, biocompatible, BIOSILK® purified, and long term bioresorbable. SERI® Surgical Scaffold is a sterile, single use only mesh and is supplied as a 10 x 25 cm sheet. SERI® Surgical Scaffold provides immediate physical and mechanical stabilization of a tissue defect through the strength and porous (scaffold like) construction of its mesh. When long term bioresorption occurs and the patient's own tissue replaces the implanted scaffold over time the mechanical integrity of the repair is maintained. SERI® Surgical Scaffold is indicated for use as a transitory scaffold for soft tissue support and repair to reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. | Device: SERI® Surgical Scaffold<br>* Standard revision augmentation (with or without implant exchange) with the adjunctive use of SERI® Surgical Scaffold placed intra- or extra-capsularly.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reoperation Rate (Per Implanted Breast) for the Presenting Condition at 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reoperation Rate (Per Implanted Breast) for Any Cause at 12 Months | This refers to the proportion of implanted breasts that will require reoperation for any cause at the end of the 12 month follow up period. The outcome is presented as the number of implanted breasts that required reoperation from the overall number of units analyzed. | 12 months | 
| AE Incidence Rates (Per Implanted Breast) at 30 Days | This refers to the AE incidence rate per implanted breast at thirty days. Outcome is reported as the number of adverse events reported for the overall number of units analyzed. | 30 days | 
| AE Incidence Rates (Per Implanted Breast) at 12 Months | This refers to the AE incidence rate per implanted breast at twelve months. Outcome is reported as the number of adverse events reported for the overall number of units analyzed. | 12 months | 
| Change in Mammometry From Baseline to 12 Months (Per Implanted Breast) | Mammometry is defined as standardized breast measurements. Mammometry was performed by direct measurement (ie with measuring tape) and indirectly through VECTRA imaging. | 12 months | 
| Difference in Mean Scores From Baseline to 12 Months Across 4 Scales of the BREAST Q (Per Patient) | The BREAST-Q is a self-administered questionnaire developed at the Memorial Sloan-Kettering Cancer Center and the University of British Columbia. This instrument specifically measured subject satisfaction and health related quality of life (QoL) following different types of breast surgery (reconstruction,augmentation, reduction, and mastectomy only). A subset of 4 scales from the augmentation module (Satisfaction with breasts, Satisfaction with outcome, Psychosocial wellbeing and Sexual wellbeing) were used in this study. In accordance with the BREAST-Q manual, subject scores were transformed into linearized measurements on a 0 to 100 scale, using the QScore software which was developed based on the Rasch model. For the transformed scores, a higher score indicated greater satisfaction or higher function. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast implant, revision augmentation, stretch deformity, fold malposition, bottoming out