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

Sofregen Medical

Status

Withdrawn

Conditions

Breast Reconstruction

Treatments

Device: Biodegradable (purified) surgical silk scaffold

Study type

Interventional

Funder types

Industry

Identifiers

NCT02033590

SURE-005

Details and patient eligibility

About

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

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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