Glucose Monitoring in Tissue Transfers

NCT00962130 | Withdrawn

• 1 other identifier: H-2008-0066
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Reconstructive Tissue Surgery

Keywords

tissue perfusion; reconstructive surgery; continuous glucose monitoring

Outcome Measures

Primary Outcomes (1)

• Perfusion and tissue transfer outcome during reconstructive surgery predicted by continuous glucose monitoring of tissue

  Up to three days post-op

Study Arms (1)

Blood Glucose Measurement

EXPERIMENTAL

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

Interventions

Continuous glucose monitoring system DEVICE

one or two monitors will be placed in the tissue to be transferred

Blood Glucose Measurement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• age less than 18
• prisoner status
• inability to participate in a standard post-operative follow-up visit

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Interventions

Continuous Glucose Monitoring

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Timothy King, MD, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2009
• First Posted: August 19, 2009
• Study Start: August 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: March 20, 2018

Record last verified: 2018-03

Locations

US (1)