Clinical and Economic Outcomes With the Use of SERI® Surgical Scaffold in Direct-to-implant Breast Reconstruction | NCT02033590 | Trialant
WithdrawnInterventionalNot ApplicableUpdated Oct 9, 2017
Clinical and Economic Outcomes With the Use of SERI® Surgical Scaffold in Direct-to-implant Breast Reconstruction
ClinicalTrials.gov ID
NCT02033590
Lead Sponsor
Sofregen Medical, Inc.INDUSTRY
Overall Status
Withdrawn
Study Type
Interventional
Phase
Not Applicable
Enrollment
0Actual
Last Update Posted
Oct 9, 2017Actual
Start Date
Jul 2014Actual
Primary Completion Date
Jul 2014Actual
Completion Date
Aug 2014Actual
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.
Breast Reconstruction
Biodegradable (purified) surgical silk scaffold
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
Female
Accepts Healthy Volunteers
No
Eligibility 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