UnknownEarly Phase 1

Detection of Flap Ischemia Using Interstitial Glucose Monitor

Canada30 participantsStarted 2015-11

Plain-language 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.

Who can participate

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Temporal correlation between interstitial glucose measurements and flap ischemia

Timeframe: within 6 days after surgery

Trial details

NCT IDNCT02604069

SponsorHamilton Health Sciences Corporation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-02

Contact for this trial

Edward Liu, MD

Edward.Liu@medportal.ca

View on ClinicalTrials.gov More Free Tissue Flaps trials