Ignite Creation Date:
2025-12-24 @ 4:17 PM
Ignite Modification Date:
2025-12-24 @ 4:17 PM
Study NCT ID:
NCT07006766
Status:
COMPLETED
Last Update Posted:
2025-06-05
First Post:
2025-05-27
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bucatini Pasta, Japanese Shirataki Konjac Noodles, and Artificial Vessels: In Search of the Ideal Low-cost Vessel Simulator for Microsurgical Education
Sponsor:
University of Wisconsin, Madison
Organization:
Study Overview
Official Title:
Bucatini Pasta, Japanese Shirataki Konjac Noodles, and Artificial Vessels: In Search of the Ideal Low-cost Vessel Simulator for Microsurgical Education
Status:
COMPLETED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to assess the strengths and weaknesses of training models that are accessible, reproducible, and geared toward new learners. Specifically, the investigators aim to compare the four following models: Japanese shirataki konjac noodle, "Dragon skin" silicone vessel, standard silicone vessel, and the "blue-blood" chicken thigh model. This information will be valuable in assessing the utility of implementing a Japanese shirataki konjac noodle model in beginner microsurgical courses for both local and global education and outreach.
Detailed Description:
The significant benefit Japanese shirataki konjac noodle as a model for microsurgical simulation training is that they are very cost effective and allow for acquisition of microsurgical skills in a low stake environment. This is particularly useful for the microsurgery novice to become familiar with the tools and basics of placing microsuture.
In this study, the evaluator will complete a "pre-exercise" survey online using a laptop in the microsurgical work space. The evaluator will be oriented to the work space and then attempt to perform an end-to-end anastomoses on each of the four models.
The following three measurements will be taken: time to perform anastomosis, number of stitches, and patency (Yes/No).
Following these trials, the evaluator will take a "post-exercise" survey. This survey will obtain the evaluator's assessment of the models including most and least valuable aspects of each model, ease \& comfort of placing a suture, and microsuture/microsurgical tool handling. Only one evaluator will be in the microsurgical lab space at one time. All study tasks will take approximately 1-2 hours. The individuals with no formal surgery/microsurgery education will be guided by an expert microsurgeon throughout the anastomoses. No varying instructional techniques will be assessed; all participants without formal training will receive identical guidance from the expert microsurgeon. The surgical residents will not need supervision or guidance. The training surgeries will not be offered if people are unable to take the research surveys.
In this study, the evaluator will complete a "pre-exercise" survey online using a laptop in the microsurgical work space. The evaluator will be oriented to the work space and then attempt to perform an end-to-end anastomoses on each of the four models.
The following three measurements will be taken: time to perform anastomosis, number of stitches, and patency (Yes/No).
Following these trials, the evaluator will take a "post-exercise" survey. This survey will obtain the evaluator's assessment of the models including most and least valuable aspects of each model, ease \& comfort of placing a suture, and microsuture/microsurgical tool handling. Only one evaluator will be in the microsurgical lab space at one time. All study tasks will take approximately 1-2 hours. The individuals with no formal surgery/microsurgery education will be guided by an expert microsurgeon throughout the anastomoses. No varying instructional techniques will be assessed; all participants without formal training will receive identical guidance from the expert microsurgeon. The surgical residents will not need supervision or guidance. The training surgeries will not be offered if people are unable to take the research surveys.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| A539730 | OTHER | UW Madison | View |