Viewing Study NCT03499002


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Study NCT ID: NCT03499002
Status: WITHDRAWN
Last Update Posted: 2019-03-13
First Post: 2018-03-26
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Teaching Medical Students How to Suture: Standard Simulation vs in Situ
Sponsor: Memorial University of Newfoundland
Organization:

Study Overview

Official Title: Teaching Medical Students How to Suture: Standard Simulation vs in Situ
Status: WITHDRAWN
Status Verified Date: 2018-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: study was discontinued
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this project is to compare in situ simulation with standard lab simulation. To do this, 30 pre-clinical medical students will be randomized into the lab or ER and taught how to suture a simple laceration. To do this, a synthesized 'skin' will be placed over a volunteer's arm and will have an incision of a predetermined length.
Detailed Description: For this study, 30 first and second year students will be equally randomized to either a standard simulation lab or the ER department to learn the skill of suturing. These students will not have any knowledge of suturing prior to this study. Each group will have 15 students. Each student will be given access to the same suturing learning video. They will each attempt 15 sutures on a lab generated skin placed over a volunteer's arm. Each incision length will be predetermined and of the same length. The student will have the opportunity to re-watch the video in between each suture attempt. The volunteer will record the student's number of attempts and whether or not they had to review the video. The idea behind this, is that students should began to plateau with their learning after about 8-9 attempts and most will no longer require the video beyond that.After the 15 attempts, the student will immediately practice 6 sutures on a second skin over the volunteer's arm, again of a predetermined incision length. At this point the students will only be allowed to practice the suturing skill and will not have access to the learning video. At this point, the student's hands will be video recorded to assess the accuracy of the skill.One week after the learning session, regardless of the environment they initially learned in, the student will be brought to the ER and again allowed to practice 6 sutures on a simulated skin placed over a volunteer's arm. The incision will be the same length as the incision in the previous practice session. Again, the student's hands will be video recorded while practicing the 6 sutures.Afterward, the student will be given a questionnaire regarding which environment they practiced in and how prepared they felt to practice in the insitu environment without learning aids.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: