Skin Flap Visible Light Spectroscopy (VLS) Oximetry for Monitoring Free-Flap Ischemia During Breast Reconstruction and Recovery

Spectros Corporation50 enrolled

Overview

The purpose of the study is to understand the relevance of tissue oximetry measures of tissue flaps during surgery and during recovery, and to determine if T-Stat is a reliable and early method of detecting compromised flaps.

The tissue saturation of free flaps will be measured before, during, and after surgery and during recovery.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Ischemia

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Under surgical breast reconstruction * Informed consent Exclusion Criteria: * Failure to give consent

Locations (1)

Mills Penisula Hospital

Burlingame, California, United States

RECRUITING

Outcomes

Primary Outcomes

Flap Failure and Compromise by Tissue Saturation Values (Efficacy)

Time frame: 72 hours

Secondary Outcomes

Oximetric Diagnosis compared to Clinical Diagnosis, Doppler

Time frame: 72 hours

Device Safety Measures (safety)

Time frame: 72 hours

Central Contacts

John Griffin, MD

CONTACT

650-348-1503

Data from ClinicalTrials.gov

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