Coblator Wand Comparative Analysis
Purpose
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.
Conditions
- Tonsillectomy
- Adenoidectomy
Eligibility
- Eligible Ages
- Between 1 Year and 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Pediatric patients scheduled for tonsillectomy and/or adenoidectomy - Parental consent and child assent (when applicable)
Exclusion Criteria
- Pregnancy
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Other
- Masking
- Double (Participant, Care Provider)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator New Coblator Ablation Wands |
|
|
|
Active Comparator Reprocessed Coblator Ablation Wands |
|
Recruiting Locations
The Bronx, New York 10467
More Details
- Status
- Recruiting
- Sponsor
- Montefiore Medical Center
Detailed Description
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.