Clinical trial · Interventional
Detection of Flap Ischemia Using Interstitial Glucose Monitor
Postoperative Monitoring of Tissue Perfusion in Microvascular Free Flaps Using Continuous Interstitial Glucose Monitoring Device: A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Free Tissue Flaps | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Continuous Glucose Monitor | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Continuous Glucose Monitor
- description
- Application of CGM for 6 days following free flap reconstruction in conjunction with clinical monitoring
- interventionNames
- Device: Continuous Glucose Monitor
Primary outcomes (1)
- measure
- Temporal correlation between interstitial glucose measurements and flap ischemia
- timeFrame
- within 6 days after surgery
Secondary outcomes (3)
- measure
- Incidence of minor side effects related to device
- timeFrame
- within 6 days after surgery
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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
References
Publications (0)
Data not yet available