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

NCT02030938 | Completed Results

• 1 other identifier: GMA-SERI-13-001
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 5

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.

Conditions

Subjects Requiring Revision Breast Augmentation Surgery

Keywords

breast implant; revision augmentation; stretch deformity; fold malposition; bottoming out

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Reoperation Rate (Per Implanted Breast) for Any Cause at 12 Months

  12 months

• AE Incidence Rates (Per Implanted Breast) at 30 Days

  30 days

• AE Incidence Rates (Per Implanted Breast) at 12 Months

  12 months

• Change in Mammometry From Baseline to 12 Months (Per Implanted Breast)

  12 months

• Difference in Mean Scores From Baseline to 12 Months Across 4 Scales of the BREAST Q (Per Patient)

  12 months

Study Arms (1)

SERI® scaffold implanted breasts

EXPERIMENTAL

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

Interventions

SERI® Surgical Scaffold DEVICE

Standard revision augmentation (with or without implant exchange) with the adjunctive use of SERI® Surgical Scaffold placed intra- or extra-capsularly.

SERI® scaffold implanted breasts

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sofregen Medical, Inc.: lead

Study Sites (5)

Mofid Plastic Surgery

La Jolla, California, 92037, United States

Location

Kind Chang Plastic Surgery - California Pacific Medical Center

San Francisco, California, 94114, United States

Location

Somerset Plastic Surgery

Troy, Michigan, 48084, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Plastic Surgery Clinic

Mountlake Terrace, Washington, 98043, United States

Location

Results Point of Contact

• Title: Clinical Project Manager
• Organization: Sofregen

fjawed@sofregen.com

4029991564

Study Officials

• Gabriel Kind

  Kind Chang Plastic Surgery - California Pacific Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2014
• First Posted: January 9, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 28, 2021
• Results First Posted: December 28, 2021

Record last verified: 2021-11

Locations

US (5)