Immunonutrition and Carbohydrate Loading Strategies in Breast Reconstruction

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 without complications. Both alloplastic and autologous forms of
reconstruction are frequently complicated by wound healing and infectious complications.
These complications range from incisional dehiscence requiring prolonged wound care and daily
dressing changes, to expander infection and extrusion requiring operative removal, to
mastectomy skin flap necrosis so severe that operative debridement is required during a
second surgery after declaration of viable skin has occurred.

This study is designed to test the hypothesis that patients undergoing immediate alloplastic
and autologous breast reconstruction following mastectomy that receive preoperative
immunonutrition and carbohydrate loading will experience a reduction in wound complications
in the 30-day postoperative period compared to a standard of care control group
(retrospective chart review) of 264 (132 alloplastic + 132 autologous) consecutive breast
reconstruction patients prior to 5/25/2018.

The overarching goal of perioperative immunonutrition supplementation is to offset the immune
and metabolic dysregulation that occurs in response to surgical stress. The key ingredients
that promote this response are amino acids (typically arginine), fatty acids and nucleotides;
these can be administered individually but are typically administered together in an enteral
or parenteral formula.

The primary outcome measure of the protocol is the incidence of wound complications 30-days
post-operative.

Secondary outcome measures are:

1. Rate of return to the operating room in the 30-day postoperative period in patients
undergoing immediate alloplastic and autologous breast reconstruction.

2. Average length of stay for patients undergoing autologous reconstruction.

3. Incidence of wound complications and return to the operating room 90-days post-operative
throughout expansion process for patients undergoing alloplastic reconstruction.

The study duration will be approximately 33 weeks assuming 100% compliance with the treatment
arms in the alloplastic and autologous populations. The time estimate is based on recent
trends in operative schedules of 2 immediate alloplastic and 2 immediate autologous breast
reconstruction operations weekly with a calculated sample size of 66 patients in each group
(total n=132). This sample size was calculated assuming significance level of 0.05, power of
80%, and 50% reduction in wound complications in the treatment group.

Inclusion Criteria:

- 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 Criteria:

- 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