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Immunonutrition and Carbohydrate Loading Strategies in Breast Reconstruction

NCT03764943 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2022-03-29

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Impact Advanced Recovery

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

Sponsors & Collaborators

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Katherine Gast, MD · University of Wisconsin, Madison

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2021-08-01
Completion
2021-11-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03764943 on ClinicalTrials.gov