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

Sofregen Medical

Status: Completed

Conditions: Subjects Requiring Revision Breast Augmentation Surgery

Treatments: Device: SERI® Surgical Scaffold

Study type: Interventional

Funder types: Industry

Identifiers

NCT02030938

GMA-SERI-13-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

SERI® scaffold implanted breasts

Experimental group

Description:

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.

Treatment:

Device: SERI® Surgical Scaffold