- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02030938
SERI® Surgical Scaffold for Soft Tissue Support in Revision Augmentation Surgery
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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La Jolla, California, United States, 92037
- Mofid Plastic Surgery
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San Francisco, California, United States, 94114
- Kind Chang Plastic Surgery - California Pacific Medical Center
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Michigan
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Troy, Michigan, United States, 48084
- Somerset Plastic Surgery
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
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Washington
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Mountlake Terrace, Washington, United States, 98043
- Plastic Surgery Clinic
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: SERI® scaffold implanted breasts
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. |
Standard revision augmentation (with or without implant exchange) with the adjunctive use of SERI® Surgical Scaffold placed intra- or extra-capsularly.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reoperation Rate (Per Implanted Breast) for Any Cause at 12 Months
Time Frame: 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
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AE Incidence Rates (Per Implanted Breast) at 30 Days
Time Frame: 30 days
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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
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AE Incidence Rates (Per Implanted Breast) at 12 Months
Time Frame: 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
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Change in Mammometry From Baseline to 12 Months (Per Implanted Breast)
Time Frame: 12 months
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Mammometry is defined as standardized breast measurements.
Mammometry was performed by direct measurement (ie with measuring tape) and indirectly through VECTRA imaging.
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12 months
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Difference in Mean Scores From Baseline to 12 Months Across 4 Scales of the BREAST Q (Per Patient)
Time Frame: 12 months
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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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gabriel Kind, Kind Chang Plastic Surgery - California Pacific Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- GMA-SERI-13-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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