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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01173133

Enrollment

Registered

2010-07-30

Start date

2009-04-30

Completion date

2010-12-31

Last updated

2011-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemia

Keywords

Free Flap, Surgery, Ischemia, Outcome, Reconstructive Plastic Surgery, Monitoring

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Under surgical breast reconstruction * Informed consent

Exclusion criteria

* Failure to give consent

Design outcomes

Primary

Measure	Time frame
Flap Failure and Compromise by Tissue Saturation Values (Efficacy)	72 hours

Secondary

Measure	Time frame
Oximetric Diagnosis compared to Clinical Diagnosis, Doppler	72 hours
Device Safety Measures (safety)	72 hours

Countries

United States

Contacts

Primary ContactJohn Griffin, MD

650-348-1503

Outcome results