Immunonutrition and Carbohydrate Loading Strategies in Breast Reconstruction

Breast Cancer Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Breast Cancer
• Communicable Diseases
• Complications Wound
• Infections
• Lymphedema
• Mastectomy; Lymphedema
• Surgical Site Infection
• Surgical Wound
• Surgical Wound Infection
• Wound Complication
• Wound Heal
• Wound Infection
• Wounds and Injuries

• NCT number: NCT03764943
• Study type: Interventional
• Source: University of Wisconsin, Madison
• Status: Completed
• Phase: Phase 3
• Start date: February 1, 2019
• Completion date: November 1, 2021