Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Complications Wound | — | UNRESOLVED | — |
| Mastectomy; Lymphedema | — | UNRESOLVED | — |
| Surgical Site Infection | — | UNRESOLVED | — |
| Surgical Wound Infection | — | UNRESOLVED | — |
| Wound Complication | — | UNRESOLVED | — |
| Wound Heal | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Impact Advanced Recovery | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Immunonutrition Intervention
- description
- Participants will consume 3 'Impact Advanced Recovery' shakes daily for 5 days prior to surgery 2 hours prior to surgery.
- interventionNames
- Dietary Supplement: Impact Advanced Recovery
Primary outcomes (1)
- measure
- Number of Incidents of Wound Complications 30-days Post-Op
- timeFrame
- up to 30 days post-op
- description
- 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.
Secondary outcomes (4)
- measure
- Number of Patients that Return to the Operating Room 30-days Post-Op
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available