Skin Flap Visible Light Spectroscopy (VLS) Oximetry for Monitoring Free-Flap Ischemia During Breast Reconstruction and Recovery
- Conditions
- Ischemia
- Registration Number
- NCT01173133
- Lead Sponsor
- Spectros Corporation
- Brief 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.
- Detailed Description
The tissue saturation of free flaps will be measured before, during, and after surgery and during recovery.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- Under surgical breast reconstruction
- Informed consent
Exclusion Criteria
- Failure to give consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Flap Failure and Compromise by Tissue Saturation Values (Efficacy) 72 hours
- Secondary Outcome Measures
Name Time Method Oximetric Diagnosis compared to Clinical Diagnosis, Doppler 72 hours Device Safety Measures (safety) 72 hours
Trial Locations
- Locations (1)
Mills Penisula Hospital
🇺🇸Burlingame, California, United States