Clinical trial NCT03764943: Immunonutrition and Carbohydrate Loading Strategies in Breast Reconstruction
Official title: Evaluating the Use of Enhanced Recovery Preoperative Immunonutrition and Carbohydrate Loading Strategies in Immediate Autologous and Alloplastic Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Wound Complication
Wound Heal
Complications Wound
Surgical Wound Infection
Surgical Site Infection
Breast Cancer
Mastectomy; Lymphedema
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 125
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective cohort study, 2 groups; alloplastic reconstruction and autologous reconstruction, same intervention
Primary purpose: SUPPORTIVE_CARE

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 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.

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 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 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.

Eligibility criteria: 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 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

Primary outcomes:
measure: Number of Incidents of Wound Complications 30-days Post-Op
timeFrame: up to 30 days post-op
Secondary outcomes:
measure: Number of Patients that Return to the Operating Room 30-days Post-Op
timeFrame: up to 30 days post-op
measure: Average Length of Hospitalization for Autologous Reconstruction Patients
timeFrame: up to 1 weeks
measure: Rate of Wound Complications for Alloplastic Reconstruction Patients up to 90-days Post-Op
timeFrame: up to 90 days post-op
measure: Number of Alloplastic Reconstruction Patients that Return to the Operating Room up to 90-days Post-Op
timeFrame: up to 90 days post-op
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Katherine Gast, MD
role: PRINCIPAL_INVESTIGATOR
References: