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

Sponsors

Lead Sponsor: University of Wisconsin, Madison

Source University of Wisconsin, Madison
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.

Overall Status Recruiting
Start Date 2019-02-01
Completion Date 2021-10-01
Primary Completion Date 2021-09-01
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of Incidents of Wound Complications 30-days Post-Op up to 30 days post-op
Secondary Outcome
Measure Time Frame
Number of Patients that Return to the Operating Room 30-days Post-Op up to 30 days post-op
Average Length of Hospitalization for Autologous Reconstruction Patients up to 1 weeks
Rate of Wound Complications for Alloplastic Reconstruction Patients up to 90-days Post-Op up to 90 days post-op
Number of Alloplastic Reconstruction Patients that Return to the Operating Room up to 90-days Post-Op up to 90 days post-op
Enrollment 140
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: Impact Advanced Recovery

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

Arm Group Label: Immunonutrition Intervention

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

Gender:

Female

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Katherine Gast, MD Principal Investigator University of Wisconsin, Madison
Overall Contact

Last Name: Cancer Connect

Phone: 800-622-8922

Email: [email protected]

Location
Facility: Status: Contact: Investigator: University of Wisconsin Hospital and Clinics Carol Soteropulos 310-245-3514 [email protected] Katherine Gast, MD Principal Investigator
Location Countries

United States

Verification Date

2021-05-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Immunonutrition Intervention

Type: Experimental

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

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Intervention Model Description: Prospective cohort study, 2 groups; alloplastic reconstruction and autologous reconstruction, same intervention

Primary Purpose: Supportive Care

Masking: None (Open Label)

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