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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02030938
Recruitment Status : Completed
First Posted : January 9, 2014
Last Update Posted : May 31, 2017
Information provided by (Responsible Party):
Sofregen Medical, Inc.

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.

Condition or disease Intervention/treatment Phase
Subjects Requiring Revision Breast Augmentation Surgery Device: SERI® Surgical Scaffold Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SERI® Surgical Scaffold for Soft Tissue Support in Revision Augmentation Surgery
Study Start Date : December 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: SERI® scaffold implanted breasts Device: SERI® Surgical Scaffold
Standard revision augmentation (with or without implant exchange) with the adjunctive use of SERI® Surgical Scaffold placed intra- or extra-capsularly.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02030938

United States, California
Mofid Plastic Surgery
La Jolla, California, United States, 92037
Kind Chang Plastic Surgery - California Pacific Medical Center
San Francisco, California, United States, 94114
United States, Michigan
Somerset Plastic Surgery
Troy, Michigan, United States, 48084
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Washington
Plastic Surgery Clinic
Mountlake Terrace, Washington, United States, 98043
Sponsors and Collaborators
Sofregen Medical, Inc.

Responsible Party: Sofregen Medical, Inc. Identifier: NCT02030938     History of Changes
Other Study ID Numbers: GMA-SERI-13-001
First Posted: January 9, 2014    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017

Keywords provided by Sofregen Medical, Inc.:
breast implant
revision augmentation
stretch deformity
fold malposition
bottoming out