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

NCT ID: NCT01173133

Last Updated: 2011-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-12-31

Brief Summary

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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

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

Conditions

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Ischemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Under surgical breast reconstruction
* Informed consent

Exclusion Criteria

* Failure to give consent
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mills-Peninsula Medical Center

UNKNOWN

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role collaborator

Spectros Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Spectros Corporation

Locations

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Mills Penisula Hospital

Burlingame, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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John Griffin, MD

Role: CONTACT

650-348-1503

Facility Contacts

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John Griffin, MD

Role: primary

650-348-1503

Other Identifiers

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FLA-001

Identifier Type: -

Identifier Source: org_study_id

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