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Improving Tissue Oxygenation in Breast Reconstruction Surgery

NCT04020172 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-08-05

No results posted yet for this study

Summary

Breast reconstruction is an integral part of breast cancer care. There are two main types of breast reconstruction: alloplastic (using implants), and autologous (using patient's tissue). The latter creates a more natural breast mound, and avoids long-term concerns requiring surgical re-intervention associated with implant-based surgery. The deep inferior epigastric perforator (DIEP) flap is the gold standard technique in autologous breast reconstruction. Complications, however, do occur with DIEP flap surgery and often stem from poor flap perfusion/oxygenation. Hence, the development of strategies to enhance flap perfusion (e.g., optimal perioperative fluid therapy) is essential. Current perioperative fluid therapy is usually guided by subjective criteria which leads to wide variations in fluids administered. We will randomly assign DIEP flap patients to receive optimal (cardiac output-guided) fluid therapy in combination with dobutamine (a medication which has potential to improve flap oxygenation) versus the current standard of care. Flap oxygenation will be monitored via near-infrared spectroscopy in all patients for up to 48 hours postoperatively. Optimal fluid therapy in combination with dobutamine may improve flap oxygenation and thereby, reduce complications.

Conditions

  • Perioperative Tissue Oxygenation

Interventions

DRUG

Dobutamine

intraoperative fluid administration will be guided by cardiac output monitoring

Sponsors & Collaborators

  • Dr. Glenio Mizubuti (MD, PhD)

    lead OTHER

Principal Investigators

  • Glenio B. Mizubuti, MD, MSc, FRCPC · Queen's University - Anesthesiology

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-12
Primary Completion
2024-05-01
Completion
2024-05-01

Countries

  • Canada

Study Locations

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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 NCT04020172 on ClinicalTrials.gov