Glucose Monitoring in Tissue Transfers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00962130
First received: August 17, 2009
Last updated: March 26, 2014
Last verified: March 2014
  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:


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 ]

Enrollment: 3
Study Start Date: August 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Blood Glucose Measurement
Subjects have sensors placed on skin before surgery and these sensors will measure the subject's glucose until the third day after surgery when they are removed.
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

Locations
United States, Wisconsin
University of Wisconsin
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: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00962130     History of Changes
Other Study ID Numbers: H-2008-0066
Study First Received: August 17, 2009
Last Updated: March 26, 2014
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 April 15, 2014