Postoperative Monitoring of Tissue Perfusion in Microvascular Free Flaps Using Continuous Interstitial Glucose Monitoring Device: A Pilot Study
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Temporal correlation between interstitial glucose measurements and flap ischemia
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Temporal correlation between interstitial glucose measurements and flap ischemia
时间窗: within 6 days after surgery
次要结局
- 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)
研究者
Ronen Avram
Associate Professor
Hamilton Health Sciences Corporation