Clinical and Economic Outcomes With the Use of SERI® Surgical Scaffold in Direct-to-implant Breast Reconstruction
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ClinicalTrials.gov Identifier: NCT02033590
Recruitment Status :
(Strategic priorities impacted study)
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Ages Eligible for Study:
18 Years to 65 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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