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

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ClinicalTrials.gov Identifier: NCT06037616
Recruitment Status : Recruiting
First Posted : September 14, 2023
Last Update Posted : September 15, 2023
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Medical Students Other: powerpoint and tutor Other: video skill Other: video errors Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: Comparison of Methods for Teaching Simple Skin Sutures to Medical Students: a Randomized Blinded Controlled Study
Actual Study Start Date : August 30, 2023
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : December 30, 2023
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: gr A: powerpoint and tutor
teaching with powerpoint and tutor
 Other: 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
 Other: powerpoint and tutor
Powerpoint on indication of skin suture and tutor for the skill to perform skin suture

Other: video skill
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
 Other: powerpoint and tutor
Powerpoint on indication of skin suture and tutor for the skill to perform skin suture

Other: video errors
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
 Other: powerpoint and tutor
Powerpoint on indication of skin suture and tutor for the skill to perform skin suture

Other: video skill
Video showing skill to perform a skin suture

Other: video errors
Video showing errors of skin suture


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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"

  3. 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"


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Medical student of the faculty of Clermont-Ferrand

Exclusion Criteria:

  • Refusal to participate
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06037616


Contacts
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Contact: Lise Laclautre 04 73 75 11 95 drci@chu-clermontferrand.fr

Locations
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France
CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63000
Contact: Alexandre Lautrette       alautrette@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Alexandre Lautrette CHU de Clermont-Ferrand
Principal Investigator: Nicolas D'Ostrevy CHU de Clermont-Ferrand
Principal Investigator: geraud galvaing Centre Jean Perrin
More Information
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT06037616    
Other Study ID Numbers: 2023 LAUTRETTE E-SUTURE
First Posted: September 14, 2023    Key Record Dates
Last Update Posted: September 15, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No