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.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Canada | Juravinski Hospital | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
Hamilton Health Sciences Corporation | Jiayi Hu, Matthew McRae, Thoma, Achilleas |
Canada,
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 |
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