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Glucose Monitoring in Tissue Transfers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by University of Wisconsin, Madison.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00962130
First received: August 17, 2009
Last updated: November 5, 2010
Last verified: November 2010
History of Changes
  Purpose

The purpose of this study is to determine if 1) a continuous glucose monitoring system can measure glucose levels in transferred tissue during reconstructive surgery, and 2) if glucose measurements from a continuous glucose monitoring system correlate with tissue blood perfusion.


Condition Intervention
Reconstructive Tissue Surgery
 Device: Continuous glucose monitoring system

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Glucose Monitoring in Tissue Transfers

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Perfusion and tissue transfer outcome during reconstructive surgery predicted by continuous glucose monitoring of tissue [ Time Frame: Up to three days post-op ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2009
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Continuous glucose monitoring system
    one or two monitors will be placed in the tissue to be transferred
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • presence of a soft tissue deformity where reconstruction with a pedicled or free tissue transfer is indicated
  • age 18 and over
  • ability to follow-up post-operatively

Exclusion Criteria:

  • age less than 18
  • prisoner status
  • inability to participate in a standard post-operative follow-up visit
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00962130

Contacts
Contact: Thomas Sitzman, MD 608-234-1048 tsitzman@uwhealth.org

Locations
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Timothy King, MD, PhD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: Timothy King, MD, PhD, University of Wisconsin
ClinicalTrials.gov Identifier: NCT00962130     History of Changes
Other Study ID Numbers: H-2008-0066
Study First Received: August 17, 2009
Last Updated: November 5, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
tissue perfusion
reconstructive surgery
continuous glucose monitoring

ClinicalTrials.gov processed this record on May 23, 2013