Immunonutrition and Carbohydrate Loading Strategies in Breast Reconstruction
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|ClinicalTrials.gov Identifier: NCT03764943|
Recruitment Status : Completed
First Posted : December 5, 2018
Last Update Posted : March 29, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Wound Complication Wound Heal Complications Wound Surgical Wound Infection Surgical Site Infection Breast Cancer Mastectomy; Lymphedema||Dietary Supplement: Impact Advanced Recovery||Phase 3|
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:
- Rate of return to the operating room in the 30-day postoperative period in patients undergoing immediate alloplastic and autologous breast reconstruction.
- Average length of stay for patients undergoing autologous reconstruction.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||125 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective cohort study, 2 groups; alloplastic reconstruction and autologous reconstruction, same intervention|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Evaluating the Use of Enhanced Recovery Preoperative Immunonutrition and Carbohydrate Loading Strategies in Immediate Autologous and Alloplastic Breast Reconstruction|
|Actual Study Start Date :||February 1, 2019|
|Actual Primary Completion Date :||August 1, 2021|
|Actual Study Completion Date :||November 1, 2021|
Experimental: Immunonutrition Intervention
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
immunonutrition shake; nutritional supplement containing amino acids, omega-3 fatty acids, and nucleotides
- Number of Incidents of Wound Complications 30-days Post-Op [ Time Frame: up to 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.
- Number of Patients that Return to the Operating Room 30-days Post-Op [ Time Frame: up to 30 days post-op ]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.
- Average Length of Hospitalization for Autologous Reconstruction Patients [ Time Frame: up to 1 weeks ]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.
- Rate of Wound Complications for Alloplastic Reconstruction Patients up to 90-days Post-Op [ Time Frame: up to 90 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.
- Number of Alloplastic Reconstruction Patients that Return to the Operating Room up to 90-days Post-Op [ Time Frame: up to 90 days post-op ]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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- 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
- Pregnant or breast-feeding women
- Incarcerated women
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03764943
|United States, Wisconsin|
|University of Wisconsin Hospital and Clinics|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Katherine Gast, MD||University of Wisconsin, Madison|
|Responsible Party:||University of Wisconsin, Madison|
|Other Study ID Numbers:||
2018-1107 ( Other Identifier: Institutional Review Board )
A539730 ( Other Identifier: UW Madison )
SMPH/SURGERY/DENTL-PLASTC SRGY ( Other Identifier: UW Madison )
Protocol version 5/8/2020 ( Other Identifier: HS-IRB UW Madison )
NCI-2018-02896 ( Other Identifier: NCI Trial ID )
|First Posted:||December 5, 2018 Key Record Dates|
|Last Update Posted:||March 29, 2022|
|Last Verified:||March 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Surgical Wound Infection
Wounds and Injuries