Hemostatic Control After Adenotonsillectomy- Open Label QuikClot Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Total Suction Electrocautery Time Required for Hemostasis Will be Recorded as Seconds
研究概览
简要总结
Hemostasis will be achieved during Pediatric Tonsillectomy/Adenoidectomy with the use of QuickClot.
详细描述
The Quickclot dressing contains Kaolin, a natural mineral that promotes the body's clotting process. This dressing will be applied for one minute to the area where the tonsils/adenoids were. The investigators are hoping to develop a standard of practice where Quickclot is a key addition for tonsillectomy surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of adenotonsillar hypertrophy causing obstructive sleep disorders
排除标准
- •Patients with signs or symptoms of obstructed breathing
- •recurrent pharyngitis
- •history of bleeding disorder
- •history of prior adenotonsillectomy
研究组 & 干预措施
QuickClot
QuickClot sponge will be applied for one minute each site of tonsillectomy and Adenoidectomy.
干预措施: QuickClot (Device)
结局指标
主要结局
Total Suction Electrocautery Time Required for Hemostasis Will be Recorded as Seconds
时间窗: at the time of surgery, 1 hour
After removal of the adenoids, a tonsil pack wrapped in QuikClot will be placed in the nasopharynx. The investigators will then perform tonsillectomy with the Microdebrider. A QuikClot roll will be placed in the tonsil fossa, and pressure applied via tonsil sponge for one minute. The contralateral tonsil will then be addressed with the same technique. The QuikClot adenoid pack is then removed and residual adenoidal bleeding is addressed with suction electrocautery, followed by placement of a second QuikClot adenoid pack. The tonsil rolls are sequentially removed, followed by control of residual hemostasis with suction electrocautery. A second set of tonsil rolls are placed. After adenoid pack is removed from nasopharynx and bleeding controlled, tonsil rolls are removed, followed by suction electrocautery for any residual hemostasis is performed.
次要结局
未报告次要终点