Immunonutrition and Carbohydrate Loading Strategies in Breast Reconstruction

NCT03764943 | Completed Phase 3 DMC

• 6 other identifiers: UW181012018-1107A539730SMPH/SURGERY/DENTL-PLASTC SRGYProtocol version 5/8/2020NCI-2018-02896
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound Complication; Wound Heal; Complications Wound; Surgical Wound Infection; Surgical Site Infection; Breast Cancer; Mastectomy; Lymphedema

Outcome Measures

Primary Outcomes (1)

• Number of Incidents of Wound Complications 30-days Post-Op

  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.

  up to 30 days post-op

Secondary Outcomes (4)

• 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

Study Arms (1)

Immunonutrition Intervention

EXPERIMENTAL

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

Dietary Supplement: Impact Advanced Recovery

Interventions

Impact Advanced Recovery DIETARY_SUPPLEMENT

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

Immunonutrition Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Related Links

• University of Wisconsin Carbone Cancer Center

MeSH Terms

Conditions

Surgical Wound Infection; Breast Neoplasms; Lymphedema

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Katherine Gast, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 5, 2018
• Study Start: February 1, 2019
• Primary Completion: August 1, 2021
• Study Completion: November 1, 2021
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)