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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 16, 2014