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Detection of Flap Ischemia Using Interstitial Glucose Monitor

NCT02604069 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-11-13

No results posted yet for this study

Summary

A simple device that objectively assesses flap perfusion - either as a stand-alone tool or an adjunct to the current monitoring method - would be a tremendous improvement in detection of early postoperative flap ischemia and, in turn, increase flap salvage and survival. In this study, the investigators aim to examine the accuracy and reliability of measuring interstitial glucose levels using Continuous Glucose Monitoring (CGM) technology as an objective method of detecting postoperative flap tissue ischemia in patients undergoing free flap-based reconstructive surgery.

Conditions

  • Free Tissue Flaps

Interventions

DEVICE

Continuous Glucose Monitor

Sponsors & Collaborators

  • Thoma, Achilleas

    collaborator INDIV

  • Jiayi Hu

    collaborator UNKNOWN

  • Matthew McRae

    collaborator UNKNOWN

  • Hamilton Health Sciences Corporation

    lead OTHER

Principal Investigators

  • Ronen Avram, MD · Associate Professor, Plastic Surgery

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-02-29

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02604069 on ClinicalTrials.gov