Detection of Flap Ischemia Using Interstitial Glucose Monitor

Free Tissue Flaps Clinical Trial

Official title:

Postoperative Monitoring of Tissue Perfusion in Microvascular Free Flaps Using Continuous Interstitial Glucose Monitoring Device: A Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02604069
• Other study ID #: CGM-2015-10
• Status: Not yet recruiting
• Phase: Phase 0
• First received: November 11, 2015
• Last updated: November 12, 2015
• Start date: November 2015

Study information

• Verified date: November 2015
• Source: Hamilton Health Sciences Corporation
• Contact: Edward Liu, MD
• Email: Edward.Liu[@]medportal.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Description:

Background:

Breast reconstruction involving microvascular free tissue transfer is a major, labour-intensive operation that provides numerous benefits for patients' psychosocial function and well-being.

Flap failure, though rare, is a devastating complication and leads to serious morbidities. It can occur in the first 24-72 hours after the operation. However, if ischemia is detected earlier, the chances for operative salvage are better. Unfortunately, the current monitoring process remains mostly subjective.

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.

Purpose:

The overall objective of this clinical pilot study is 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.

Methods:

In this pilot cohort study, the investigators aim to prospectively include 30 free flaps in total from 10-20 patients undergoing DIEP-based breast reconstruction by one surgeon at Juravinski Hospital. Patients will be recruited at the pre-operative consultation. The transcutaneous sensor of the CGM device will be inserted into the subcutaneous layer of the flap upon completion of surgery, while an additional sensor will be placed on the patient's thigh as control. These devices are blinded and will start recording the flap's interstitial glucose levels. The patient will be admitted and the flap will be assessed clinically as per protocol. On-call residents will be given a data collection sheet to document the exact time they were alerted about a flap, the clinical finding, and the subsequent decision made. Once an endpoint has been reached for a flap, the CGM sensor will be removed and its data extracted.

Data Analysis:

The timing of occurrence of low interstitial glucose levels and rapid glucose level decline will be analyzed with the timing of clinical concerns raised about the flap. The systemic glucose level will be used as a control for the flap glucose level. The investigators aim to analyze the temporal correlation between interstitial glucose measurements and clinical findings of the flap's vascular status (eg. vessel occlusion, ischemia). Statistical analysis will be done with assistance by a biostatistician.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Free Tissue Flaps

Intervention

Device:
• Continuous Glucose Monitor

Locations

Country	Name	City	State
Canada	Juravinski Hospital	Hamilton	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	Jiayi Hu, Matthew McRae, Thoma, Achilleas

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Temporal correlation between interstitial glucose measurements and flap ischemia		within 6 days after surgery	No
Secondary	Incidence of minor side effects related to device		within 6 days after surgery	No
Secondary	Incidence of major adverse effects related to the device		within 6 days after surgery	No
Secondary	Incidences of technical issues related to the device		within 6 days after surgery	No