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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Spectros Corporation.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Mills-Peninsula Medical Center
Stanford University
Information provided by:
Spectros Corporation
ClinicalTrials.gov Identifier:
NCT01173133
First received: July 28, 2010
Last updated: January 30, 2011
Last verified: January 2011
History of Changes
  Purpose

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
Ischemia

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Spectros Corporation:

Primary Outcome Measures:
  • Flap Failure and Compromise by Tissue Saturation Values (Efficacy) [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Oximetric Diagnosis compared to Clinical Diagnosis, Doppler [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Device Safety Measures (safety) [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: April 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Detailed Description:

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

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Clinical Coordinator, Spectros Corporation
ClinicalTrials.gov Identifier: NCT01173133     History of Changes
Other Study ID Numbers: FLA-001
Study First Received: July 28, 2010
Last Updated: January 30, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013