Subjects Requiring Revision Breast Augmentation Surgery
Conditions
Keywords
breast implant, revision augmentation, stretch deformity, fold malposition, bottoming out
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.
Interventions
DEVICESERI® Surgical Scaffold
Standard revision augmentation (with or without implant exchange) with the adjunctive use of SERI® Surgical Scaffold placed intra- or extra-capsularly.
Sponsors
Sofregen Medical, Inc.
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
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reoperation Rate (Per Implanted Breast) for the Presenting Condition at 12 Months. | 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
| Measure | Time frame | Description |
|---|---|---|
| Reoperation Rate (Per Implanted Breast) for Any Cause at 12 Months | 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. |
| AE Incidence Rates (Per Implanted Breast) at 30 Days | 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. |
| AE Incidence Rates (Per Implanted Breast) at 12 Months | 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. |
| Change in Mammometry From Baseline to 12 Months (Per Implanted Breast) | 12 months | Mammometry is defined as standardized breast measurements. Mammometry was performed by direct measurement (ie with measuring tape) and indirectly through VECTRA imaging. |
| Difference in Mean Scores From Baseline to 12 Months Across 4 Scales of the BREAST Q (Per Patient) | 12 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SERI® Surgical Scaffold Implanted Breasts SERI® Surgical Scaffold: Standard revision augmentation (with or without implant exchange) with the adjunctive use of SERI® Surgical Scaffold placed intra- or extra-capsularly. | 34 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | SERI® Surgical Scaffold Implanted Breasts |
|---|---|
| Age, Continuous | 44.4 years STANDARD_DEVIATION 13.37 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 30 Participants |
| Sex/Gender, Customized Sex Female - Child-bearing Potential | 22 Participants |
| Sex/Gender, Customized Sex Female - Non Child-bearing Potential | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 34 |
| other Total, other adverse events | 13 / 34 |
| serious Total, serious adverse events | 1 / 34 |
Outcome results
Primary
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.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Skin Stretch | Reoperation Rate (Per Implanted Breast) for the Presenting Condition at 12 Months. | 0 Implanted breasts |
| Fold Malposition | Reoperation Rate (Per Implanted Breast) for the Presenting Condition at 12 Months. | 0 Implanted breasts |
Secondary
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.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Skin Stretch | AE Incidence Rates (Per Implanted Breast) at 12 Months | 3 Adverse events |
Secondary
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.
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Skin Stretch | AE Incidence Rates (Per Implanted Breast) at 30 Days | 1 Adverse events |
Secondary
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Skin Stretch | Change in Mammometry From Baseline to 12 Months (Per Implanted Breast) | -1.42 cm | Standard Deviation 7.06 |
| Fold Malposition | Change in Mammometry From Baseline to 12 Months (Per Implanted Breast) | -1.24 cm | Standard Deviation 4.41 |
Secondary
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Skin Stretch | Difference in Mean Scores From Baseline to 12 Months Across 4 Scales of the BREAST Q (Per Patient) | 34.8 units on a scale | Standard Deviation 24.68 |
Secondary
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.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Skin Stretch | Reoperation Rate (Per Implanted Breast) for Any Cause at 12 Months | 1 Implanted breasts |