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OpenTrials
Completed

NCT Number: NCT07006766

Bucatini Pasta, Japanese Shirataki Konjac Noodles, and Artificial Vessels: In Search of the Ideal Low-cost Vessel Simulator for Microsurgical Education

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UW School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant is able to commit 1-2 hours to the study.
  • Participants must either be a surgical resident or an individual with no formal surgery/microsurgery education. Five participants will be placed into each of these two categories.

Exclusion criteria

  • Participant is unable to commit 1-2 hours to the study.

Treatment and study plan

Microsurgical Training Models

Other

Four models will be compared: Japanese shirataki konjac noodle, "Dragon skin" silicone vessel, standard silicone vessel from Microsurgery and Regenerative Medicine (MSRM) lab, and the "blue-blood" chicken thigh model.

Primary outcomes

  1. Time to Perform Anastomosis

    Time frame: up to 30 min

  2. Number of Stitches

    Time frame: up to 30 min

  3. Patency (either Yes or No)

    Time frame: up to 30 min

    Patency is the condition of being 'open'.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 5, 2025
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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