Wounds and Injuries

All Conditions

Blood and Lymph Conditions

Neoplasms

Skin and Connective Tissue Diseases

Infections

Symptoms and General Pathology

Lymphedema

Breast Neoplasms

Communicable Diseases

Surgical Wound

Wound Infection

Surgical Wound Infection

Disease Attributes

Lymphatic Diseases

Postoperative Complications

Other Dietary Supplements

All Drugs and Chemicals

Omega 3 Fatty Acid

Participants will consume 3 'Impact Advanced Recovery' shakes daily for 5 days prior to surgery 2 hours prior to surgery.

immunonutrition shake; nutritional supplement containing amino acids, omega-3 fatty acids, and nucleotides

Impact Advanced Recovery

Katherine Gast, MD

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.

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.

Prospective cohort study, 2 groups; alloplastic reconstruction and autologous reconstruction, same intervention

Immunonutrition and Carbohydrate Loading Strategies in Breast Reconstruction

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

Wound complications are defined by the American College of Surgeons National Surgery Quality Improvement Program (ACS-NSQIP) to include surgical site infection (SSI), deep SSI, organ/space SSI, wound disruption/dehiscence, seroma, and skin necrosis.

The intervention tests the impact of immunonutrition on wound complications post-op. This outcome directly measures this impact by identifying the number of patients that require additional surgery due to wound complications 30-days Post-Op, compared to a retrospective standard of care control group.

The intervention tests the impact of immunonutrition on wound complications post-op. This outcome directly measures this impact by identifying average length of hospitalization for Autologous Reconstruction patients, compared to a retrospective standard of care control group.

The intervention tests the impact of immunonutrition on wound complications post-op. This outcome directly measures this impact by identifying the number of patients undergoing Alloplastic Reconstruction that require additional surgery due to wound complications 90-days Post-Op, compared to a retrospective standard of care control group.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Immunonutrition and Carbohydrate Loading Strategies in Breast Reconstruction	NCT03764943	Wound Complicat... Wound Heal Complications W... Surgical Wound ... Surgical Site I... Breast Cancer Mastectomy; Lym...	Impact Advanced...	18 Years -	University of Wisconsin, Madison
Immunonutrition and Carbohydrate Loading Strategies in Breast Reconstruction	NCT03764943	Wound Complicat... Wound Heal Complications W... Surgical Wound ... Surgical Site I... Breast Cancer Mastectomy; Lym...	Impact Advanced...	18 Years -	University of Wisconsin, Madison

Spots Global Cancer Trial Database for impact advanced recovery