Teaching Simple Skin Sutures to Medical Students (E-SUTURE)

September 14, 2023 updated by: University Hospital, Clermont-Ferrand

Comparison of Methods for Teaching Simple Skin Sutures to Medical Students: a Randomized Blinded Controlled Study

Learning the simple skin suture is part of the surgical basics required for all medical students, including future general practitioners.

However, there is no data in the educational literature to help choose the best learning technique.

Several teams have offered video learning showing the correct technique. Level n+1 peer learning was also proposed, without and with supervision by an expert.

The investigators propose to carry out a prospective study comparing the quality of sutures and knowledge according to the chosen learning method.

Study Overview

Detailed Description

Send to medical student a teaching package two weeks before simulation session to practice skin suture. There are 4 teaching packages related to 4 interventional groups The skin suture performed by medical students are recorded on video. 1 video per medical student.

The skin sutures recorded in these video are rated by two blinded expert with evaluation grid.

After the simulation session, the students complete knowledge, self-confidence, satisfaction and mental load questionnaires

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Medical student of the faculty of Clermont-Ferrand

Exclusion Criteria:

  • Refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: gr A: powerpoint and tutor
teaching with powerpoint and tutor
Powerpoint on indication of skin suture and tutor for the skill to perform skin suture
Active Comparator: gr B: powerpoint and tutor and video skill
teaching with powerpoint and tutor and video showing skill to perform a skin suture
Powerpoint on indication of skin suture and tutor for the skill to perform skin suture
Video showing skill to perform a skin suture
Active Comparator: gr C: powerpoint and tutor and video error
teaching with powerpoint and tutor and video showing errors
Powerpoint on indication of skin suture and tutor for the skill to perform skin suture
Video showing errors of skin suture
Active Comparator: gr D: powerpoint and tutor and video skill and error
teaching with powerpoint and tutor and video showing skill to perform a skin suture and errors
Powerpoint on indication of skin suture and tutor for the skill to perform skin suture
Video showing skill to perform a skin suture
Video showing errors of skin suture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of skin suture
Time Frame: 15 days after simulation session
Quality of suture on anonymized video recording during the assessment day, rated by the blinded expert using an evaluation grid evaluation grid is made up of 14 items from the litterature the minimum value is: 0 (worse outcome) and maximum value is: 15 points (better outcome)
15 days after simulation session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
knowledge of student
Time Frame: 15 days after simulation session
8 multiple choice questions (5 items per MCQ); the minimum value is: 0 (worse outcome) and maximum value is: 8 points (better outcome)
15 days after simulation session
self-confidence of student
Time Frame: 15 days after simulation session
self evaluation with a Likert scale (5points); point 0 corresponds to "no confidence"; point 5 corresponds to "total confidence"
15 days after simulation session
mental load of student
Time Frame: 15 days after simulation session
self evaluation with a Likert scale (9points); point 0 corresponds to "very low"; point 9 corresponds to "very high"
15 days after simulation session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Alexandre Lautrette, CHU de Clermont-Ferrand
  • Principal Investigator: Nicolas D'Ostrevy, CHU de Clermont-Ferrand
  • Principal Investigator: geraud galvaing, Centre Jean Perrin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2023

Primary Completion (Estimated)

September 30, 2023

Study Completion (Estimated)

December 30, 2023

Study Registration Dates

First Submitted

August 30, 2023

First Submitted That Met QC Criteria

September 7, 2023

First Posted (Actual)

September 14, 2023

Study Record Updates

Last Update Posted (Actual)

September 15, 2023

Last Update Submitted That Met QC Criteria

September 14, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2023 LAUTRETTE E-SUTURE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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