Assessing Perfusion of an Osteotomised Scapula and Latissimus Dorsi Chimeric Free Flap on the Thoracodorsal Artery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Adequacy of blood perfusion of osteomized lateral border of the scapula bone supplied by the angular artery
研究概览
简要总结
The gold standard for reconstruction of the jaw is the utilization of a bone free tissue transfer. Scapula reconstruction is an excellent option for elderly patients, those with significant comorbidities and for complex defects with large soft tissue reconstructive requirements. The scapula is supplied by the angular artery and circumflex scapula arteries. No studies have shown with objective measures, the viability of the lateral border of the scapula bone supplied by either the angular artery or circumflex scapula arteries. The aim of this observational study is to demonstrate with objective clinical measures, via SPY-Q software analysis, that the angular artery can adequately supply the scapula tip flap including with a single osteotomy giving two bone segments, in 30 patients who will undergo reconstructive head and neck surgery at LHSC.
详细描述
The aim of this follow-up observational study is to demonstrate with objective clinical measures via SPY-Q software analysis, that the angular artery can adequately supply the scapula tip flap including a single distal osteotomy segment. 30 patients undergoing mandible or maxillary reconstruction with the scapular tip flap will be included. An osteotomy will be performed at up to 8cm from the scapular tip. The adequacy of blood supply to the scapula tip flap after a distal osteotomy and the latissimus dorsi muscle component of the flap will be measured intraoperatively, using SPY-Q software analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Adult patients (18 years and older) seen at the head and neck clinic at London Health Sciences Centre (LHSC)
- •Planned to undergo a maxillary and/or mandibular reconstruction surgery with a scapular tip flap
排除标准
- •• Younger than 18 years of age
- •History of failing microvascular flaps
- •Hypersensitivity toward ICG or related substances (e.g., imaging agents), defined as (based on ICG product monograph): possibly life-threatening dizziness, severe itching, hives, nausea, difficulty breathing, rash, low blood pressure)
- •Breastfeeding
- •Clinically apparent cognitive impairment
结局指标
主要结局
Adequacy of blood perfusion of osteomized lateral border of the scapula bone supplied by the angular artery
时间窗: Intra-operatively
To measure the adequacy of blood perfusion of osteotomised lateral border of the scapula bone supplied by the angular artery via SPY-Q analysis in patients undergoing a scapular tip flap for reconstruction of a jaw defect
Blood perfusion of osteomized lateral border of the scapula
时间窗: Intra-operatively
To measure the adequacy of blood perfusion of osteotomised lateral border of the scapula bone supplied by the angular artery via SPY-Q analysis in patients undergoing a scapular tip flap for reconstruction of a jaw defect
次要结局
- To assess flap viability(Intra-operatively; up to 10 days post-operatively)
- Concordance between subjective and objective measure of blood perfusion(Intra-operatively; up to 10 days post-operatively)
- Blood perfusion of latissmus dorsi(Intra-operatively)
研究者
Danielle MacNeil
Principal Investigator
Western University, Canada