Clinical Trial: Protexa® Versus TiLoopBra® in Immediate Breast Reconstruction- A Pilot Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Protexa® Versus TiLoopBra® in Immediate Breast Reconstruction- A Pilot Study

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 Summary:
Sponsor: Medical University of Vienna

Current Primary Outcome:

  • complications [ Time Frame: up to two weeks after surgery ]
    hematoma, seroma, infection, skin necrosis, capsular contracture, implant loss
  • change of baseline patient quality of life after 3 and 6 months [ Time Frame: up to two weeks after surgery (=baseline), 3 and 6 months after surgery ]
    questionnaire
  • change of baseline cosmetic outcome after 3 and 6 months [ Time Frame: up to two weeks after surgery (=baseline), 3 and 6 months after surgery ]
    four point Harris Scale (1=poor, 4=excellent)
  • change of baseline thickness of the tissue overlying the implant at the lower pole after 3 and 6 months [ Time Frame: up to two weeks after surgery (=baseline), 3 and 6 months after surgery ]
    The thickness of the tissue covering the implant in the lower pole im mm measured by ultrasound
  • complications [ Time Frame: 3 months after surgery ]
    hematoma, seroma, infection, skin necrosis, capsular contracture, implant loss
  • complications [ Time Frame: 6 months after surgery ]
    hematoma, seroma, infection, skin necrosis, capsular contracture, implant loss


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Medical University of Vienna

Dates:
Date Received: September 18, 2015
Date Started: July 2013
Date Completion:
Last Updated: September 26, 2015
Last Verified: September 2015