Circumferential Periareolar Mastopexy Using SERI Surgical Scaffold

NCT02293798 | Completed Results

• 1 other identifier: 820
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the clinical performance of SERI® Surgical Scaffold to maintain the size of the areola by providing additional soft tissue support after circumferential periareolar mastopexy.

Conditions

Mastopexy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Areolar Dilation of up to 6mm at 12 Months

  areolar dilation of up to 6mm

  12 months after SERI implantation

Study Arms (1)

SERI

EXPERIMENTAL

Subjects receiving SERI for mastopexy

Device: silk surgical scaffold

Interventions

silk surgical scaffold DEVICE

surgical implant

Also known as: SERI surgical scaffold

SERI

Eligibility Criteria

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

You may qualify if:

• Female, age 18 years or older desiring a reduction in size of nipple areola complex
• Be in good health and suited to general anesthesia and planned treatments
• Non smokers
• If the subject is of childbearing potential, have a urine pregnancy test evaluated as negative (assessed at baseline examination (Visit 1), agree to use contraception as prevention to avoid pregnancy during the study period
• Previous augmentation with silicone-filled or saline-filled breast implants or patients desiring periareolar mastopexy
• Requiring surgery for ptotic breasts

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/qualification visit (Visit 1)
• Pregnant or nursing
• Advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy
• 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
• Is taking medications known to impair wound healing (e.g. corticosteroids, chemotherapeutic agents etc.,)
• Bleeding disorders (e.g., Hemophilia, von Willebrand Disease) including the following medications \& supplements: Warfarin, platelet inhibitors (e.g. NSAIDs or Clopidogrel) not stopped within 2 weeks of the operation and herbal supplements known to predispose to bleeding (e.g. Gingko and Ginseng)
• 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
• Be currently enrolled in another clinical study of an implanted device in the breast or plan to enroll in another clinical study within the study period, which could affect wound healing in the breast repair site and/or would not allow the patient to attend all study visits as outlined within this protocol

Sponsors & Collaborators

• Mark Mofid MD: lead
• Allergan: collaborator

Study Sites (1)

Unknown Facility

La Jolla, California, 92037, United States

Location

Results Point of Contact

• Title: Dr. Mark Mofid
• Organization: Mark Mofid, M.D.

drmofid@drmofid.com

8589099000

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: INDIV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 13, 2014
• First Posted: November 18, 2014
• Study Start: August 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: September 10, 2019
• Results First Posted: September 10, 2019

Record last verified: 2019-08

Locations

US (1)