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A Study of the Safety and Effectiveness of the Mentor Larger Size MemoryGel Ultra High Profile Breast Implants in Subjects who are Undergoing Primary Breast Reconstruction or Revision Reconstruction
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety and effectiveness of the Mentor MemoryGel® larger size ultra high profile breast implants for patients who are undergoing primary or revision reconstruction surgery.
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The Use of Topical Tranexamic Acid in Implant-Based Breast Reconstruction with Acellular Dermal Matrix
Rochester, MN
The purpose of this study is to determine whether administration of Topical Transexamic Acid (TXA) at the time of tissue expander placement in the setting of implant-based breast reconstruction reduces postoperative drain volume, as well as reducing the time until drains meet criteria for removal.
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Automated Breast Measurements
Jacksonville, FL
The correction of breast asymmetries requires the capture of accurate surface images and anatomical measurements of the breast. Currently, surface breast measurements are performed manually. We hypothesize that using the true depth imaging sensors embedded within mobile devices and differential algorithms, breast measurements can be performed in an automated format. These measurments can be potentially utilized for the production of asymmetric garments to improve comfort and symmetry.
The study plans to include female subjects (ages 18 – 85) previously evaluated for aesthetic and reconstructive breast surgery and add new subjects who desire aesthetic or reconstructive breast surgery ...
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A Study to Evaluate Surgical Sterility, the Microbiome and Infections Following Mastectomy with Immediate / Tissue Expander Reconstruction
Rochester, MN
The purpose of this study is to evaluate surgical sterility, the microbiome, and infections post mastectomy with immediate/tissue expander surgery by using OR camera recording, surgical site and/or microbiome analysis.
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A Study to Evaluate Surgical Outcomes and Quality of Life after Breast Reconstruction
Scottsdale/Phoenix, AZ
The purpose of this study is to investigate the surgical outcomes that patients have after breast reconstruction, and to assess how reconstruction has affected their quality of life.
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A Study to Evaluate Same Day Discharge Post-mastectomy with/without Alloplastic Breast Reconstruction
Rochester, MN
In the light of the pandemic, institutions have had to take greater precautions and instigate procedures to aim to improve safety and reduce risk for patients undergoing surgery. One intiative was designed to implement a same day discharge for patients undergoing mastectomy with or without alloplastic reconstruction. This study aims to evaluate the outcomes and patient satisfaction with same day mastectomy with or without alloplastic reconstruction following COVID-19 and compare satisfaction and outcomes (e.g complications) with patients pre-COVID 19. This is part of a quality improvement project.
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Pragmatic Randomized Trial of Proton vs. Photon Therapy for Patients With Non-Metastatic Breast Cancer: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial
Scottsdale/Phoenix, AZ
A pragmatic randomized clinical trial of patients with locally advanced breast cancer randomized to either proton or photon therapy and followed longitudinally for cardiovascular morbidity and mortality, health-related quality of life, and cancer control outcomes. Quality of life is the outcome measure for the estimated primary completion date of November, 2020.
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Study to Evaluate Effects of Pre-Surgery Therapy on Direct-to-Implant Reconstruction as Compared to Immediate Tissue Expander-Based Reconstruction
Rochester, MN
The purpose of this study is to compare and identify different forms/regimens of chemotherapy/hormone therapy in breast cancer patients who underwent mastectomy and subsequent immediate breast reconstruction (tissue expander or direct-to-implant). Subsequently, correlate these findings to assess overall surgical and clinical outcomes.
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Botulinum Toxin A (Botox) in Tissue Expander Breast Reconstruction
Rochester, MN
Each year, the number of breast cancer survivors who choose post-mastectomy breast reconstruction keeps rising. Among women who elect to pursue breast reconstruction, approximately 75% will choose prosthetic breast reconstruction. Implant-based breast reconstruction is frequently achieved in two-stages. The first stage consists of the placement of a tissue expander after mastectomy. This is followed by a period of weekly tissue expansions that can last several months. In the second stage, the tissue expander is removed in a surgical procedure and replaced with a permanent breast implant. Tissue expansion is a well-established breast reconstruction technique characterized by high success rates and ...
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A Study to Evaluate the Safety of the Goldilocks Procedure with Implant-Based Reconstruction
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess outcomes, satisfaction and aesthetics of two different breast reconstruction techniques (Goldilocks alone, and Goldilocks with Implant-Based Reconstruction) and compare its safety, patient satisfaction, aesthetic evaluation and complications.
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Post-Surgical Based Efforts to Reduce Preventable Readmissions and Optimize Length of Stay
Rochester, MN
The investigators believe that the lessons learned from studies regarding 30-day and 90-day readmission are primarily due to failure of early symptom recognition, and medical error. Through the aid of remote monitoring and early symptom detection, the hypothesis for the current proposal is that interventions can be recommended in an earlier, remote fashion that may result in earlier post-surgical discharge, prevent decompensation, and prevent increased readmissions that have been associated with decreased LOS in other surgical populations.
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A Study to Evaluate Treating Post-Mastectomy Radiation Injury in Breast Cancer Patients with Adipose-Induced Regeneration of Breast Skin (AIR Breast)
Jacksonville, FL
The primary purpose of this study is to identify the therapeutic effect of Adipose-Induced Regeneration (AIR) in radiation-induced skin injury of post-mastectomy breast cancer patients.