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