Status:
COMPLETED
Immunonutrition and Carbohydrate Loading Strategies in Breast Reconstruction
Lead Sponsor:
University of Wisconsin, Madison
Conditions:
Wound Complication
Wound Heal
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
This study is designed to test the following hypothesis: patients undergoing immediate alloplastic and autologous breast reconstruction following mastectomy that receive preoperative immunonutrition w...
Detailed Description
Breast reconstruction following mastectomy for breast cancer is one of the most common operations performed by plastic and reconstructive surgeons. Unfortunately, breast reconstruction does not come w...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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 formula that prevents safe consumption of this product.
- Impact Advanced Recovery is 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
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2021
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT03764943
Start Date
February 1 2019
End Date
November 1 2021
Last Update
March 29 2022
Active Locations (1)
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1
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792