NCT07006766

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 23, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 5, 2025

Completed
Last Updated

June 5, 2025

Status Verified

May 1, 2025

Enrollment Period

1.2 years

First QC Date

May 27, 2025

Last Update Submit

May 27, 2025

Conditions

Keywords

microsuturemicrosurgerysurgical trainingmicrosurgical educationglobalaccessibilitynoodlesyntheticvesselanastomosispatencyeducationoutreachlow-costmicrosurgical simulationsimulationvessel simulator

Outcome Measures

Primary Outcomes (3)

  • Time to Perform Anastomosis

    up to 30 min

  • Number of Stitches

    up to 30 min

  • Patency (either Yes or No)

    Patency is the condition of being 'open'.

    up to 30 min

Study Arms (1)

Microsurgical training

Participants will complete pre-exercise surveys, attempt 4 microsurgical anastomoses, and complete post-exercise surveys.

Other: Microsurgical Training Models

Interventions

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.

Microsurgical training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Surgical residents or individual with no formal microsurgical education.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UW School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

Location

Related Publications (3)

  • Prunieres GJ, Taleb C, Hendriks S, Miyamoto H, Kuroshima N, Liverneaux PA, Facca S. Use of the Konnyaku Shirataki noodle as a low fidelity simulation training model for microvascular surgery in the operating theatre. Chir Main. 2014 Apr;33(2):106-11. doi: 10.1016/j.main.2013.12.003. Epub 2014 Feb 4.

    PMID: 24603055BACKGROUND
  • Mohammad S, Hanstein R, Lo Y, Levy IM. Validating a Low-Fidelity Model for Microsurgical Anastomosis Training. JB JS Open Access. 2021 Jul 16;6(3):e20.00148. doi: 10.2106/JBJS.OA.20.00148. eCollection 2021 Jul-Sep.

    PMID: 34291182BACKGROUND
  • Ng ZY, Honeyman C, Lellouch AG, Pandya A, Papavasiliou T. Smartphone-Based DIY Home Microsurgical Training with 3D Printed Microvascular Clamps and Japanese Noodles. Eur Surg Res. 2023;64(2):301-303. doi: 10.1159/000521439. Epub 2021 Dec 15.

    PMID: 34915484BACKGROUND

Study Officials

  • Samuel Poore, MD, PhD

    UW School of Medicine and Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2025

First Posted

June 5, 2025

Study Start

December 23, 2023

Primary Completion

February 15, 2025

Study Completion

February 15, 2025

Last Updated

June 5, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations