A phase II randomized controlled trial comparing pectoralis major myocutaneous flap outcomes using conventional and Indocyanine green angiography technique in oral cancers
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To determine the outcomes of PMMC flap using ICG compared with conventional technique in terms of flap loss and dehiscence
研究概览
简要总结
After resection of primary in oral cancers, PMMC flap is harvested. PMMC flap is assessed clinically for perfusion by using the colour. Patients randomized to conventional technique will undergo flap inset. Patients randomized to ICGA technique will be given 2.5mg ICG and ICG flouresence system will be used to pick up real-time fluorescent images of the flap to asses perfusion. The flap is then inset into the defect area. Similar procedure repeated after flap inset into the defect. Outcomes assessed in terms of full thickness and partial thickness flap loss at day 5 and day 30.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Biopsy proven cancers of oral cavity Requiring pedicled PMMC flaps for reconstruction.
排除标准
- •Large oral cancers requiring free flaps Secondary primary with prior treatment with chemotherapy or radiotherapy Patients refusing to consent Unresectable disease.
结局指标
主要结局
To determine the outcomes of PMMC flap using ICG compared with conventional technique in terms of flap loss and dehiscence
时间窗: Day 5 and Day 30
次要结局
- Orocutaneous fistula(Receiving radiotherapy on time)
研究者
Dr Hema Siri Kottu
All India Institute of Medical Sciences