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Protocol No. UW18101

Principal Investigator Gast, Katherine

Phase III

Age Group Adult

Scope Local

Sponsor Type Institutional

Title Evaluating the Use of Enhanced Recovery Preoperative Immunonutrition and Carbohydrate Loading Strategies in Immediate Autologous and Alloplastic Breast Reconstruction

Objective The purpose of this research study is to determine whether preoperative immunonutrition supplementation (with Impact Advanced Recovery, a nutritional shake) and carbohydrate loading (with Boost Breeze) can reduce the rate of wound complications and the need for additional unplanned surgeries in patients undergoing immediate breast reconstruction. Additionally, we would like to study the impact of these supplements on the length of your hospital stay following surgery if you are undergoing autologous reconstruction

Treatment The patients will be split into two groups:
  • Subjects undergoing alloplastic reconstruction will be enrolled into group 1 of the study
  • Subjects undergoing autologous reconstruction will be enrolled into group 2 of the study
    All patients will be provided the nutritional supplements (one case of 15, 200mL Impact Advanced Recovery shakes, one 200mL Boost Breeze drink), as well as a"data collection sheet";"consumption diary"; with the dates that they will be drinking the Impact Advanced Recovery and Boost Breeze with boxes to mark each shake they consumed daily
  • You will be instructed to drink three Impact Advanced Recovery shakes daily (around morning, mid-day and evening) for 5 days prior to their surgical date. They will then be instructed to drink the Boost Breeze on the day of surgery, 2 hours prior to the scheduled surgery time

  • Description Phase III Study of Immunonutrition and Carbohydrate Loading Strategies in Breast Reconstruction

    Key Eligibility
  • Age equal to and greater than 18 years.
  • Medically cleared to undergo oncologic resection and breast reconstructive surgery (including associated anesthesia) at the University of Wisconsin Hospital
  • Undergoing unilateral or bilateral immediate alloplastic or autologous breast reconstruction by Drs. Afifi, Garland, Gast, Michelotti, Poore, Rao or Siebert
  • Pregnant or breast-feeding women.
  • Incarcerated women
  • Males
  • Individuals unable to give consent due to another condition such as impaired decision-making capacity
  • Women with intolerance or allergy to any ingredients contained within the Impact Advanced Recovery or Boost Breeze formulas that prevents safe consumption of these products
  • Impact Advanced Recovery and Boost Breeze formulas are both suitable for lactose intolerance, gluten-free, kosher, and halal diets
  • We will exclude individuals with galactosemia
  • Women who are unable to take oral nutritional supplements

  • Applicable Disease Sites Breast

    Status Open

    Participating Institutions UW Hospital and Clinics