Breast Reconstruction
Conditions
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.
Interventions
DEVICEBiodegradable (purified) surgical silk scaffold
Sponsors
Sofregen Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of implant loss (SERI® and breast implant) | 52 weeks |
Outcome results
None listed