NCT04286087撤回不适用
Assessment of Clinical Outcomes in Closure of Deep Neck Space Infection Incisions
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Number of participants with reinfection
研究概览
简要总结
The purpose of this study is to determine if closure of deep neck infection incisions at the time of extraoral drain removal has any impact on rates of reinfection and to determine if this treatment will have any impact on scar formation and qualitative measures of pain or impact on quality of life during the post-operative healing period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •deep neck space infection
- •who require a conservative unilateral submandibular neck incision to access affected deep fascial neck spaces
排除标准
- •pregnant females
- •cognitively impaired individuals
- •deep neck space infections which require bilateral neck incisions, large neck apron incisions, or placement of negative pressure therapy.
研究组 & 干预措施
Investigational Arm
Experimental
干预措施: neck incisions closed at bedside at the time of drain removal under local anesthesia (Procedure)
Control Group
Active Comparator
干预措施: standard treatment (Procedure)
结局指标
主要结局
Number of participants with reinfection
时间窗: 1-2 weeks post intervention
次要结局
- Number of participants requiring a scar revision surgery(4-6 months post intervention)
研究者
Craig Bradley Pearl
Assistant Professor
The University of Texas Health Science Center, Houston
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