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

NCT01173133 — Unknown, 50 participants, Spectros Corporation

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Registry	NCT01173133
Status	Unknown
Study type	Observational
Enrollment	50 (Estimated)
Sponsor	Spectros Corporation (Industry); collaborators: Mills-Peninsula Medical Center, Stanford University
Conditions	Ischemia
Dates	start 2009-04-01, primary completion 2010-12-01 (estimated), completion 2010-12-01 (estimated), first posted 2010-07-30, last updated 2011-02-01
Locations	1 site in United States

-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.

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+Detailed description

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

+Outcome measures

Primary outcomes

Flap Failure and Compromise by Tissue Saturation Values (Efficacy) [72 hours]

Secondary outcomes

Oximetric Diagnosis compared to Clinical Diagnosis, Doppler [72 hours]
Device Safety Measures (safety) [72 hours]

+Eligibility

Sex: All

Inclusion Criteria:

* Under surgical breast reconstruction
* Informed consent

Exclusion Criteria:

* Failure to give consent

+Locations (1)

Facility	City	Country	Status
Mills Penisula Hospital	Burlingame, California	United States	Recruiting