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Search / Trial NCT03757793

Near-infrared Spectroscopy for Monitoring Tissue Oxygenation in Breast Reconstruction

Launched by UNIVERSITY HOSPITAL, ANTWERP · Nov 27, 2018

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Near Infrared Spectroscopy

ClinConnect Summary

This clinical trial is looking at a new way to monitor the oxygen levels in tissue during breast reconstruction surgery, specifically for women who are having a DIEP flap procedure. The goal is to see if a tool called near-infrared spectroscopy (NIRS) can help doctors detect early problems with blood flow that might occur after surgery. This could help improve patient outcomes and reduce complications.

To participate in this study, women who are scheduled for either one or both sides of breast reconstruction using the DIEP flap method may be eligible. However, those who do not agree to provide written consent, who are having a repeat surgery, or who have allergies to certain adhesives will not be able to join. If you decide to participate, you will undergo the usual preparation for surgery, and the NIRS device will be used during the procedure to monitor your tissue health. This study is currently recruiting participants, and your involvement could contribute to important research in breast reconstruction.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • scheduled for elective unilateral or bilateral breast reconstruction via DIEP flap procedure.
  • Exclusion Criteria:
  • refusal of written informed consent
  • redo-surgery
  • known history of allergy to adhesives

About University Hospital, Antwerp

University Hospital Antwerp is a leading academic medical center dedicated to advancing healthcare through innovative research and clinical trials. With a strong emphasis on patient-centered care, the hospital fosters a collaborative environment that integrates cutting-edge scientific inquiry with state-of-the-art medical practices. As a prominent sponsor of clinical trials, University Hospital Antwerp is committed to enhancing medical knowledge and improving treatment outcomes across a wide range of specialties, leveraging its expertise to contribute significantly to the global medical community.

Locations

Edegem, Antwerp, Belgium

Patients applied

0 patients applied

Trial Officials

Vera Saldien, MD

Principal Investigator

University Hospital, Antwerp

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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