Spots Global Cancer Trial Database for Protexa® Versus TiLoopBra® in Immediate Breast Reconstruction- A Pilot Study
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Trial Identification
Brief Title: Protexa® Versus TiLoopBra® in Immediate Breast Reconstruction- A Pilot Study
Official Title: Protexa® Versus TiLoopBra® in Immediate Breast Reconstruction- A Pilot Study
Study ID: NCT02562170
Study Description
Brief Summary: Randomized controlled trial to look at early complications, cosmetic outcome, patient satisfaction and thickness of the tissue overlying the implant at the lower pole in immediate implant based breast reconstruction after Skin or Nipple Sparing Mastectomy with either a mesh (TiLOOP Bra) or an ADM (Protexa). Multicenter austrian trial with four breast cancer centers, 50 patients randomized 1:1 in the TiLoop or Protexa group.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Medical University of Vienna, Vienna, , Austria
Contact Details
Name: Daphne Gschwantler-Kaulich, Ass.Prof.Dr.
Affiliation: Medical University Vienna
Role: PRINCIPAL_INVESTIGATOR
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