Medical StudentsE-SUTURENCT06037616
Teaching Simple Skin Sutures to Medical Students
A study testing powerpoint and tutor, video skill and video errors in people with Medical Students, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Medical Students
- What is being tested?
- powerpoint and tutor, video skill and video errors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 30 Aug 2023to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Medical student of the faculty of Clermont-Ferrand
Who cannot join
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Alexandre Lautrette, alautrette@chu-clermontferrand.fr
About this study
Official title: 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.
Read the 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
- Conditions
- Medical Students
- Being tested
- powerpoint and tutor, video skill, video errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
powerpoint and tutorOther
Powerpoint on indication of skin suture and tutor for the skill to perform skin suture
video skillOther
Video showing skill to perform a skin suture
video errorsOther
Video showing errors of skin suture
| Study group | Role | What they receive |
|---|---|---|
| gr A: powerpoint and tutor | Active comparator | teaching with powerpoint and tutor Receives: Other: powerpoint and tutor |
| gr B: powerpoint and tutor and video skill | Active comparator | teaching with powerpoint and tutor and video showing skill to perform a skin suture Receives: Other: powerpoint and tutor; Other: video skill |
| gr C: powerpoint and tutor and video error | Active comparator | teaching with powerpoint and tutor and video showing errors Receives: Other: powerpoint and tutor; Other: video errors |
| gr D: powerpoint and tutor and video skill and error | Active comparator | teaching with powerpoint and tutor and video showing skill to perform a skin suture and errors Receives: Other: powerpoint and tutor; Other: video skill; Other: video errors |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of skin suture
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)
Measured: 15 days after simulation session
Secondary outcomes (3)
knowledge of student
8 multiple choice questions (5 items per MCQ); the minimum value is: 0 (worse outcome) and maximum value is: 8 points (better outcome)
Measured: 15 days after simulation session
self-confidence of student
self evaluation with a Likert scale (5points); point 0 corresponds to "no confidence"; point 5 corresponds to "total confidence"
Measured: 15 days after simulation session
mental load of student
self evaluation with a Likert scale (9points); point 0 corresponds to "very low"; point 9 corresponds to "very high"
Measured: 15 days after simulation session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start30 Aug 2023
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical StudentsStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre Lautrette, Principal investigator, University Hospital, Clermont-FerrandNicolas D'Ostrevy, Principal investigator, University Hospital, Clermont-Ferrandgeraud galvaing, Principal investigator, Centre Jean Perrin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06037616
- Sponsor's protocol ID
- 2023 LAUTRETTE E-SUTURE
- Acronym
- E-SUTURE
- Status last verified
- Aug 2023
- First submitted
- 30 Aug 2023
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Methods for Teaching Simple Skin Sutures to Medical Students: a Randomized Blinded Controlled Study
- ClinicalTrials.gov ID
- NCT06037616
- Acronym / sponsor ID
- E-SUTURE / 2023 LAUTRETTE E-SUTURE
- Conditions
- Medical Students
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| gr A: powerpoint and tutor | Active comparator | Other: powerpoint and tutorteaching with powerpoint and tutor |
| gr B: powerpoint and tutor and video skill | Active comparator | Other: powerpoint and tutor, Other: video skillteaching with powerpoint and tutor and video showing skill to perform a skin suture |
| gr C: powerpoint and tutor and video error | Active comparator | Other: powerpoint and tutor, Other: video errorsteaching with powerpoint and tutor and video showing errors |
| gr D: powerpoint and tutor and video skill and error | Active comparator | Other: powerpoint and tutor, Other: video skill, Other: video errorsteaching with powerpoint and tutor and video showing skill to perform a skin suture and errors |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Medical student of the faculty of Clermont-Ferrand
Key exclusion criteria (1 listed)
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| powerpoint and tutorPowerpoint on indication of skin suture and tutor for the skill to perform skin suture | Other | gr A: powerpoint and tutor, gr B: powerpoint and tutor and video skill, gr C: powerpoint and tutor and video error, gr D: powerpoint and tutor and video skill and error |
| video skillVideo showing skill to perform a skin suture | Other | gr B: powerpoint and tutor and video skill, gr D: powerpoint and tutor and video skill and error |
| video errorsVideo showing errors of skin suture | Other | gr C: powerpoint and tutor and video error, gr D: powerpoint and tutor and video skill and error |
Primary outcome
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)
3 secondary outcomes
knowledge of student
Time frame: 15 days after simulation session
self-confidence of student
Time frame: 15 days after simulation session
mental load of student
Time frame: 15 days after simulation session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre Lautrette principal investigator
University Hospital, Clermont-Ferrand
Nicolas D'Ostrevy principal investigator
University Hospital, Clermont-Ferrand
geraud galvaing principal investigator
Centre Jean Perrin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing powerpoint and tutor, video skill and video errors in people with Medical Students, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (04 73 75 11 95, drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of skin suture (time frame: 15 days after simulation session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023.