Postoperative Monitoring of Tissue Perfusion in Microvascular Free Flaps Using Continuous Interstitial Glucose Monitoring Device: A Pilot Study
Trial Snapshot
- Phase
- Phase 1
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Temporal correlation between interstitial glucose measurements and flap ischemia
Study Overview
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.
Detailed 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:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Continuous Glucose Monitor
Application of CGM for 6 days following free flap reconstruction in conjunction with clinical monitoring
Intervention: Continuous Glucose Monitor (Device)
Outcomes
Primary Outcomes
Temporal correlation between interstitial glucose measurements and flap ischemia
Time Frame: within 6 days after surgery
Secondary Outcomes
- Incidence of minor side effects related to device(within 6 days after surgery)
- Incidences of technical issues related to the device(within 6 days after surgery)
- Incidence of major adverse effects related to the device(within 6 days after surgery)
Investigators
Ronen Avram
Associate Professor
Hamilton Health Sciences Corporation