Clinical trial NCT02030938: SERI® Surgical Scaffold for Soft Tissue Support in Revision Augmentation Surgery
Official title: SERI® Surgical Scaffold for Soft Tissue Support in Revision Augmentation Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subjects Requiring Revision Breast Augmentation Surgery
Keywords: breast implant
revision augmentation
stretch deformity
fold malposition
bottoming out
Lead sponsor: Sofregen Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2014-01-09
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Reoperation Rate (Per Implanted Breast) for the Presenting Condition at 12 Months.
timeFrame: 12 months
Secondary outcomes:
measure: Reoperation Rate (Per Implanted Breast) for Any Cause at 12 Months
timeFrame: 12 months
measure: AE Incidence Rates (Per Implanted Breast) at 30 Days
timeFrame: 30 days
measure: AE Incidence Rates (Per Implanted Breast) at 12 Months
timeFrame: 12 months
measure: Change in Mammometry From Baseline to 12 Months (Per Implanted Breast)
timeFrame: 12 months
measure: Difference in Mean Scores From Baseline to 12 Months Across 4 Scales of the BREAST Q (Per Patient)
timeFrame: 12 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Mofid Plastic Surgery
state: California
city: San Francisco
country: United States
facility: Kind Chang Plastic Surgery - California Pacific Medical Center
state: California
city: Troy
country: United States
facility: Somerset Plastic Surgery
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Mountlake Terrace
country: United States
facility: Plastic Surgery Clinic
state: Washington
Study officials:
affiliation: Kind Chang Plastic Surgery - California Pacific Medical Center
name: Gabriel Kind
role: PRINCIPAL_INVESTIGATOR
References: