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  • Evaluation Of The Safety And Effectiveness Of The GORE® Tissue Reinforcement For Breast Reconstruction Device (TRBR Device) When Used In The Reinforcement Of Breast Reconstruction Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

    This record is for the Prospective treatment arm, the Retrospective cohort will have a seperate protocol and IRBe record.

    The GORE Tissue Reinforcement for Breast Reconstruction (TRBR) research study will look at breast reconstruction during mastectomy procedures. There will be two arms in this study, a Prospective Arm, where data will be collected for a new medical device called the Tissue Reinforcement for Breast Reconstruction (TRBR) Device and a Retrospective Arm where data will be collected from subjects who have previously had surgery and received no additional tissue reinforcement in their breast reconstruction surgery. This research study will look at the safety of the Study Device and the success of the participants breast reconstruction. The Study Device is investigational, which means it has not yet been used nor approved by the FDA for this treatment. The data collected in this study will be compared to the data collected in the Retrospective Arm.
  • Postoperative outcomes and Patient Satisfaction for patients admitted to the Mayo Clinic Florida Care Hotel after mastectomy and tissue expander placement Jacksonville, Fla.

    The purpose of this study is to investigate post operative complications in patients who underwent mastectomy followed by tissue expander reconstruction and were admitted to the Care Hotel for overnight observation compared to the standard hospital admission and those who are discharged home. The secondary intent is to investigate overall patient satisfaction with the Care Hotel Model.​  
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