- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06037616
Teaching Simple Skin Sutures to Medical Students (E-SUTURE)
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
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lise Laclautre
- Phone Number: 04 73 75 11 95
- Email: drci@chu-clermontferrand.fr
Study Locations
-
-
-
Clermont-Ferrand, France, 63000
- Recruiting
- CHU de Clermont-Ferrand
-
Contact:
- Alexandre LAUTRETTE
- Email: alautrette@chu-clermontferrand.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Medical student of the faculty of Clermont-Ferrand
Exclusion Criteria:
- Refusal to participate
Study Plan
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
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
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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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