Trial record 12 of 14 for:    Open Studies | "Breast Implants"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Allergan Medical
Sponsor:
Information provided by (Responsible Party):
Allergan Medical
ClinicalTrials.gov Identifier:
NCT02030938
First received: January 7, 2014
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

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 Intervention
Subjects Requiring Revision Breast Augmentation Surgery
Device: SERI® Surgical Scaffold

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: SERI® Surgical Scaffold for Soft Tissue Support in Revision Augmentation Surgery

Further study details as provided by Allergan Medical:

Primary Outcome Measures:
  • Reoperation rate (per implanted breast) for the presenting condition at 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 50
Study Start Date: December 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SERI® scaffold implanted breasts
Revision augmentation of the breast with adjunctive SERI® surgical scaffold
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.
Other Name: SERI® Surgical Scaffold

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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:inframmary 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02030938

Contacts
Contact: Allergan Medical devicetrials@allergan.com

Locations
United States, Michigan
Recruiting
Troy, Michigan, United States
Sponsors and Collaborators
Allergan Medical
  More Information

No publications provided

Responsible Party: Allergan Medical
ClinicalTrials.gov Identifier: NCT02030938     History of Changes
Other Study ID Numbers: GMA-SERI-13-001
Study First Received: January 7, 2014
Last Updated: June 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Allergan Medical:
breast implant
revision augmentation
stretch deformity
fold malposition
bottoming out

ClinicalTrials.gov processed this record on July 22, 2014