N/A
N=34
SERI® Surgical Scaffold for Soft Tissue Support in Revision Augmentation Surgery
Subjects Requiring Revision Breast Augmentation Surgery
Bottom Line
View on ClinicalTrials.gov: NCT02030938 ↗Enrolled (actual)
34
Serious AEs
2.9%
Results posted
Dec 2021
Primary outcome: Primary: Reoperation Rate (Per Implanted Breast) for the Presenting Condition at 12 Months. — 0; 0 Implanted breasts
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SERI® Surgical Scaffold (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Sofregen Medical, Inc.
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reoperation Rate (Per Implanted Breast) for the Presenting Condition at 12 Months. |
0; 0 | — |
| SECONDARY Reoperation Rate (Per Implanted Breast) for Any Cause at 12 Months |
1 | — |
| SECONDARY AE Incidence Rates (Per Implanted Breast) at 30 Days |
1 | — |
| SECONDARY AE Incidence Rates (Per Implanted Breast) at 12 Months |
3 | — |
| SECONDARY Change in Mammometry From Baseline to 12 Months (Per Implanted Breast) |
-1.42; -1.24 | — |
| SECONDARY Difference in Mean Scores From Baseline to 12 Months Across 4 Scales of the BREAST Q (Per Patient) |
34.8 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT02030938). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.