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

Not Applicable

Withdrawn

• Conditions: Breast Reconstruction

• Registration Number: NCT02033590
• Lead Sponsor: Sofregen Medical, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-09
• Study First Submitted QC: 2014-01-10
• Study First Posted: 2014-01-13
• Study Start: 2014-07
• Primary Completion: 2014-07
• Study Completion: 2014-08
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-05
• Last Update Posted: 2017-10-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incidence rate of implant loss (SERI® and breast implant)	52 weeks