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

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ClinicalTrials.gov Identifier: NCT01173133
Recruitment Status : Unknown
Verified January 2011 by Spectros Corporation.
Recruitment status was:  Recruiting
First Posted : July 30, 2010
Last Update Posted : February 1, 2011
Sponsor:
Collaborators:
Mills-Peninsula Medical Center
Stanford University
Information provided by:
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.

Condition or disease
Ischemia

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

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Skin Flap Visible Light Spectroscopy (VLS) Oximetry for Monitoring Free-Flap Ischemia During Breast Reconstruction and Recovery
Study Start Date : April 2009
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010



Primary Outcome Measures :
  1. Flap Failure and Compromise by Tissue Saturation Values (Efficacy) [ Time Frame: 72 hours ]

Secondary Outcome Measures :
  1. Oximetric Diagnosis compared to Clinical Diagnosis, Doppler [ Time Frame: 72 hours ]
  2. Device Safety Measures (safety) [ Time Frame: 72 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing surgical breast reconstruction.
Criteria

Inclusion Criteria:

  • Under surgical breast reconstruction
  • Informed consent

Exclusion Criteria:

  • Failure to give consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01173133


Contacts
Contact: John Griffin, MD 650-348-1503

Locations
United States, California
Mills Penisula Hospital Recruiting
Burlingame, California, United States, 94010-3282
Contact: John Griffin, MD    650-348-1503      
Principal Investigator: John Griffin, MD         
Sponsors and Collaborators
Spectros Corporation
Mills-Peninsula Medical Center
Stanford University

Responsible Party: Clinical Coordinator, Spectros Corporation
ClinicalTrials.gov Identifier: NCT01173133     History of Changes
Other Study ID Numbers: FLA-001
First Posted: July 30, 2010    Key Record Dates
Last Update Posted: February 1, 2011
Last Verified: January 2011

Keywords provided by Spectros Corporation:
Free Flap
Surgery
Ischemia
Outcome
Reconstructive Plastic Surgery
Monitoring

Additional relevant MeSH terms:
Ischemia
Pathologic Processes