NCT02604069

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 13, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Last Updated

November 13, 2015

Status Verified

November 1, 2015

Enrollment Period

3 months

First QC Date

November 11, 2015

Last Update Submit

November 12, 2015

Conditions

Free Tissue Flaps

Keywords

Breast reconstructionBreast cancerMicrosurgeryContinuous flap monitor

Outcome Measures

Primary Outcomes (1)

  • Temporal correlation between interstitial glucose measurements and flap ischemia

    within 6 days after surgery

Secondary Outcomes (3)

  • Incidence of minor side effects related to device

    within 6 days after surgery

  • Incidence of major adverse effects related to the device

    within 6 days after surgery

  • Incidences of technical issues related to the device

    within 6 days after surgery

Study Arms (1)

Continuous Glucose Monitor

EXPERIMENTAL

Application of CGM for 6 days following free flap reconstruction in conjunction with clinical monitoring

Device: Continuous Glucose Monitor

Interventions

Continuous Glucose MonitorDEVICE
Continuous Glucose Monitor

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are undergoing unilateral or bilateral breast reconstruction with free flap including DIEP flaps at Hamilton Health Sciences, starting from the date of ethics approval.

You may not qualify if:

  • Patients with diabetes (on oral antiglycemic medications or insulin-dependent)
  • Patients who are on immunosuppressive medication
  • Patients undergoing breast reconstruction involving expanders or implants
  • Patients with active infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Juravinski Hospital

Hamilton, Ontario, L8V 1C3, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Ronen Avram, MD

    Associate Professor, Plastic Surgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Edward Liu, MD

CONTACT

Edward.Liu@medportal.ca

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 11, 2015

First Posted

November 13, 2015

Study Start

November 1, 2015

Primary Completion

February 1, 2016

Last Updated

November 13, 2015

Record last verified: 2015-11

Locations

CA(1)