NCT01173133

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

February 1, 2011

Status Verified

January 1, 2011

Enrollment Period

1.7 years

First QC Date

July 28, 2010

Last Update Submit

January 30, 2011

Conditions

Ischemia

Keywords

Free FlapSurgeryIschemiaOutcomeReconstructive Plastic SurgeryMonitoring

Outcome Measures

Primary Outcomes (1)

  • Flap Failure and Compromise by Tissue Saturation Values (Efficacy)

    72 hours

Secondary Outcomes (2)

  • Oximetric Diagnosis compared to Clinical Diagnosis, Doppler

    72 hours

  • Device Safety Measures (safety)

    72 hours

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing surgical breast reconstruction.

You may qualify if:

  • Under surgical breast reconstruction
  • Informed consent

You may not qualify if:

  • Failure to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mills Penisula Hospital

Burlingame, California, 94010-3282, United States

RECRUITING

MeSH Terms

Conditions

Ischemia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

John Griffin, MD

CONTACT

650-348-1503

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 28, 2010

First Posted

July 30, 2010

Study Start

April 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

February 1, 2011

Record last verified: 2011-01

Locations

US(1)