Clinical and Economic Outcomes With the Use of SERI® Surgical Scaffold in Direct-to-implant Breast Reconstruction
Not Applicable
Withdrawn
- Conditions
- Breast Reconstruction
- Interventions
- Device: Biodegradable (purified) surgical silk scaffold
- 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
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- WITHDRAWN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
- Arm && Interventions
Group Intervention Description SERI® Surgical Scaffold Biodegradable (purified) surgical silk scaffold -
- Primary Outcome Measures
Name Time Method Incidence rate of implant loss (SERI® and breast implant) 52 weeks
- Secondary Outcome Measures
Name Time Method