Skin Flap Visible Light Spectroscopy (VLS) Oximetry for Monitoring Free-Flap Ischemia During Breast Reconstruction and Recovery
Information source: Spectros Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ischemia
Phase: N/A
Status: Recruiting
Sponsored by: Spectros Corporation Overall contact:
John Griffin, MD, Phone: 650-348-1503
Summary
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.
Clinical Details
Official title: Skin Flap Visible Light Spectroscopy (VLS) Oximetry for Monitoring Free-Flap Ischemia During Breast Reconstruction and Recovery
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Flap Failure and Compromise by Tissue Saturation Values (Efficacy)
Secondary outcome: Oximetric Diagnosis compared to Clinical Diagnosis, DopplerDevice Safety Measures (safety)
Detailed description:
The tissue saturation of free flaps will be measured before, during, and after surgery and
during recovery.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Under surgical breast reconstruction
- Informed consent
Exclusion Criteria:
- Failure to give consent
Locations and Contacts
John Griffin, MD, Phone: 650-348-1503
Mills Penisula Hospital, Burlingame, California 94010-3282, United States; Recruiting
John Griffin, MD, Phone: 650-348-1503
John Griffin, MD, Principal Investigator
Additional Information
Starting date: April 2009
Last updated: January 30, 2011
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