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

Completed · Not applicable

Conditions studied: Subjects Requiring Revision Breast Augmentation Surgery

In brief

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.

Key facts

Study ID

NCT02030938

Run by

Sofregen Medical, Inc.

People needed

34

Starts

2013-12-01

Expected to finish

2015-12-01

Last updated by the study team

2021-12-28

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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)

Where it is running

• Mofid Plastic Surgery — La Jolla, California, United States
• Kind Chang Plastic Surgery - California Pacific Medical Center — San Francisco, California, United States
• Somerset Plastic Surgery — Troy, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Plastic Surgery Clinic — Mountlake Terrace, Washington, United States

Full record on ClinicalTrials.gov

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