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

August 17, 2009
March 26, 2014
August 2009
June 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00962130 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Glucose Monitoring in Tissue Transfers
Glucose Monitoring in Tissue Transfers

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Reconstructive Tissue Surgery
Device: Continuous glucose monitoring system
one or two monitors will be placed in the tissue to be transferred
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.
Intervention: Device: Continuous glucose monitoring system
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00962130
H-2008-0066
No
University of Wisconsin, Madison
University of Wisconsin, Madison
Not Provided
Principal Investigator: Timothy King, MD, PhD University of Wisconsin, Madison
University of Wisconsin, Madison
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP