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临床试验/NCT07635719
NCT07635719招募中不适用

Comparative Analysis of Efficiency, Technical Performance, and Environmental Cost Between Reprocessed and New Coblator Wands in Intracapsular Tonsillectomies and Adenoidectomies

Montefiore Medical Center1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Surgeon Comfort

研究概览

简要总结

This study will address the gap in coblator wands by comparing the performance of reprocessed coblator wands with new wands in terms of efficiency and technical issues. As part of the evaluation, the investigator team will conduct the technical performance of the life cycle assessment of reprocessed versus new coblation wands based on the methodology described in the literature (see References) in studies of laryngoscopes.

详细描述

Reprocessed operating room tools offer surgeons an opportunity to use equipment that have been inferenced to incur lower hospital and environmental costs. Tools that are "disposable" are collected by reprocessing companies that then refurbish and sterilize the instrument and sell it back to the hospital at a reduced cost. Advocates argue that they may serve as a means of controlling increasing healthcare costs and further, because few if any new raw materials are needed for the reprocessing, environmental costs are also hypothesized to be reduced. However, the use of reprocessed tools has demonstrated variable results in clinical performance across different surgical domains. Comparable performance of reprocessed orthopedic drill bits to new ones in terms of force, heat, and usability has been demonstrated (see References). It has been shown that blinded surgeons could not distinguish between new and reprocessed arthroscopic shavers and found equivalent sharpness on engineering tests. In contrast, it has been found that reprocessed laparoscopic trocars had more imperfections and higher leak rates (see References) reported more abnormalities in reprocessed harmonic scalpels with poorer tissue handling outcomes. There remains a lack of consensus about the reliability of reprocessed surgical tools, including coblator wands.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Pediatric patients scheduled for tonsillectomy and/or adenoidectomy
  • •Parental consent and child assent (when applicable)

排除标准

  • •Pregnancy

研究组 & 干预措施

New Coblator Ablation Wands

Active Comparator

干预措施: New Coblator Ablation Wands (Device)

Reprocessed Coblator Ablation Wands

Active Comparator

干预措施: Reprocessed Medline Coblator Ablation Wands (Device)

结局指标

主要结局

Surgeon Comfort

时间窗: Following the procedure, up to 4 hours

The primary outcome for this study is surgeon comfort in terms of using the new or reprocessed coblator wand again based on data collected from the post-procedure surveys. Surgeon comfort will be assessed as a dichotomous (yes/no) measure following the procedure. The number of instances for which the surgeon is comfortable using the new or reprocessed coblator wand will be summarized by study arm using descriptive statistics.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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