Clinical and Economic Outcomes With the Use of SERI® Surgical Scaffold in Direct-to-implant Breast Reconstruction

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Allergan Medical
ClinicalTrials.gov Identifier:
NCT02033590
First received: January 9, 2014
Last updated: July 9, 2014
Last verified: July 2014
  Purpose

The objective of this study is to prospectively observe clinical and economic outcomes with the use of SERI® in direct-to-implant breast reconstruction.


Condition Intervention
Breast Reconstruction
Device: Biodegradable (purified) surgical silk scaffold

Study Type: Interventional

Resource links provided by NLM:


Further study details as provided by Allergan Medical:

Primary Outcome Measures:
  • Incidence rate of implant loss (SERI® and breast implant) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 0
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SERI® Surgical Scaffold Device: Biodegradable (purified) surgical silk scaffold

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be willing to undergo immediate breast reconstruction following a skin-sparing or nipple sparing mastectomy with healthy, sufficiently thick, well-vascularized skin flaps, and the implantation of SERI® Surgical Scaffold and breast implant
  • Be female, between 18 and 65 years of age at the time of enrollment

Exclusion Criteria:

  • Have undergone prior radiation treatment on the study breast(s) and/or is preoperatively evaluated to require radiation treatment to the study breast(s) during the course of the study
  • Have undergone a skin reducing mastectomy
  • Have a BMI that is <17 or ≥ 30
  • Predicted implant weight more than 500 grams
  • Have a known allergy to silk
  • Have an abscess or active infection at any location within one month prior to surgery
  • Be pregnant, lactating, or if of childbearing potential, be unwilling to use contraceptive methods and avoid pregnancy throughout the study
  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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Allergan Medical
ClinicalTrials.gov Identifier: NCT02033590     History of Changes
Other Study ID Numbers: SURE-005
Study First Received: January 9, 2014
Last Updated: July 9, 2014
Health Authority: Unspecified

ClinicalTrials.gov processed this record on September 18, 2014