NCT06037616

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 30, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

August 30, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 14, 2023

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

September 15, 2023

Status Verified

August 1, 2023

Enrollment Period

1 month

First QC Date

August 30, 2023

Last Update Submit

September 14, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

    15 days after simulation session

Secondary Outcomes (3)

  • knowledge of student

    15 days after simulation session

  • self-confidence of student

    15 days after simulation session

  • mental load of student

    15 days after simulation session

Study Arms (4)

gr A: powerpoint and tutor

ACTIVE COMPARATOR

teaching with powerpoint and tutor

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

Other: powerpoint and tutorOther: video skill

gr C: powerpoint and tutor and video error

ACTIVE COMPARATOR

teaching with powerpoint and tutor and video showing errors

Other: powerpoint and tutorOther: 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

Other: powerpoint and tutorOther: video skillOther: video errors

Interventions

Powerpoint on indication of skin suture and tutor for the skill to perform skin suture

gr A: powerpoint and tutorgr B: powerpoint and tutor and video skillgr C: powerpoint and tutor and video errorgr D: powerpoint and tutor and video skill and error

Video showing skill to perform a skin suture

gr B: powerpoint and tutor and video skillgr D: powerpoint and tutor and video skill and error

Video showing errors of skin suture

gr C: powerpoint and tutor and video errorgr D: powerpoint and tutor and video skill and error

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Medical student of the faculty of Clermont-Ferrand

You may not qualify if:

  • Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

Study Officials

  • Alexandre Lautrette

    CHU de Clermont-Ferrand

    PRINCIPAL INVESTIGATOR
  • Nicolas D'Ostrevy

    CHU de Clermont-Ferrand

    PRINCIPAL INVESTIGATOR
  • geraud galvaing

    Centre Jean Perrin

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2023

First Posted

September 14, 2023

Study Start

August 30, 2023

Primary Completion

September 30, 2023

Study Completion

December 30, 2023

Last Updated

September 15, 2023

Record last verified: 2023-08

Locations