Sutured LacerationNCT03499002
Teaching Medical Students How to Suture: Standard Simulation vs in Situ
A study testing Simulated Learning Environment in people with Sutured Laceration and Laceration, run by Memorial University of Newfoundland.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sutured Laceration, Laceration
- What is being tested?
- Simulated Learning Environment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2018to Jun 2018
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pre clinical medical students (year one or two)
Who cannot join
- Medical students not in first or second year training
- Extensive knowledge or background with suturing
About this study
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.
Read the 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.
- Conditions
- Sutured Laceration, Laceration
- Being tested
- Simulated Learning Environment
- Keywords
- Simulation, Medical Students, In Situ Simulation
- Medical subject headings
- Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulated Learning EnvironmentOther
Also called Simulation lab, ER in situ simulation
Intervention is the environment in which the medical student will learn to practice how to suture. The end goal is to determine the impact each environment has on their ability to learn the skill.
| Study group | Role | What they receive |
|---|---|---|
| Simulation Lab | Experimental | Not described Receives: Other: Simulated Learning Environment |
| ER in situ Simulation | Experimental | Not described Receives: Other: Simulated Learning Environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
How each simulated learning environment effects a student's ability to learn how to suture
Each student will complete a post survey questionnaire after their attempt to suture in the ER department. This will help determine the impact and therefore, which environment was more conducive to learning how to suture.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study startApr 2018 (estimated)
- Primary completionMay 2018 (estimated)
- Study completionJun 2018 (estimated)
Why it stopped: study was discontinued
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Sutured LacerationStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial University of Newfoundland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chrystal Horwood, MD, Principal investigator, Memorial University of Newfoundland and Labrador
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499002
- Sponsor's protocol ID
- MUNChrystal
- Status last verified
- Apr 2018
- First submitted
- 26 Mar 2018
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roussin CJ, Weinstock P. SimZones: An Organizational Innovation for Simulation Programs and Centers. Acad Med. 2017 Aug;92(8):1114-1120. doi: 10.1097/ACM.0000000000001746.
PubMed 28562455Jagneaux T, Caffery TS, Musso MW, Long AC, Zatarain L, Stopa E, Freeman N, Quin CC, Jones GN. Simulation-Based Education Enhances Patient Safety Behaviors During Central Venous Catheter Placement. J Patient Saf. 2021 Sep 1;17(6):425-429. doi: 10.1097/PTS.0000000000000425.
PubMed 28984729Sorensen JL, Ostergaard D, LeBlanc V, Ottesen B, Konge L, Dieckmann P, Van der Vleuten C. Design of simulation-based medical education and advantages and disadvantages of in situ simulation versus off-site simulation. BMC Med Educ. 2017 Jan 21;17(1):20. doi: 10.1186/s12909-016-0838-3.
PubMed 28109296Ullman E, Kennedy M, Di Delupis FD, Pisanelli P, Burbui AG, Cussen M, Galli L, Pini R, Gensini GF. The Tuscan Mobile Simulation Program: a description of a program for the delivery of in situ simulation training. Intern Emerg Med. 2016 Sep;11(6):837-41. doi: 10.1007/s11739-016-1401-2. Epub 2016 Feb 9.
PubMed 26861702Haji FA, Rojas D, Childs R, de Ribaupierre S, Dubrowski A. Measuring cognitive load: performance, mental effort and simulation task complexity. Med Educ. 2015 Aug;49(8):815-27. doi: 10.1111/medu.12773.
PubMed 26152493Rosen MA, Hunt EA, Pronovost PJ, Federowicz MA, Weaver SJ. In situ simulation in continuing education for the health care professions: a systematic review. J Contin Educ Health Prof. 2012 Fall;32(4):243-54. doi: 10.1002/chp.21152.
PubMed 23280527Petrosoniak A, Auerbach M, Wong AH, Hicks CM. In situ simulation in emergency medicine: Moving beyond the simulation lab. Emerg Med Australas. 2017 Feb;29(1):83-88. doi: 10.1111/1742-6723.12705. Epub 2016 Oct 17.
PubMed 27748042Naismith LM, Cheung JJ, Ringsted C, Cavalcanti RB. Limitations of subjective cognitive load measures in simulation-based procedural training. Med Educ. 2015 Aug;49(8):805-14. doi: 10.1111/medu.12732.
PubMed 26152492
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teaching Medical Students How to Suture: Standard Simulation vs in Situ
- ClinicalTrials.gov ID
- NCT03499002
- Acronym / sponsor ID
- MUNChrystal
- Conditions
- Sutured Laceration, Laceration
- Keywords
- Simulation, Medical Students, In Situ Simulation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study was discontinued
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Memorial University of NewfoundlandUniversity, hospital or other
- Study start
- Apr 2018 (estimated)
- Primary completion
- May 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 17 Apr 2018 (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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simulation Lab | Experimental | Other: Simulated Learning Environment |
| ER in situ Simulation | Experimental | Other: Simulated Learning Environment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pre clinical medical students (year one or two)
Key exclusion criteria (2 listed)
- Medical students not in first or second year training
- Extensive knowledge or background with suturing
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 |
|---|---|---|
| Simulated Learning EnvironmentAlso: Simulation lab, ER in situ simulationIntervention is the environment in which the medical student will learn to practice how to suture. The end goal is to determine the impact each environment has on their ability to learn the skill. | Other | ER in situ Simulation, Simulation Lab |
Primary outcome
How each simulated learning environment effects a student's ability to learn how to suture
Time frame: 1 week
Each student will complete a post survey questionnaire after their attempt to suture in the ER department. This will help determine the impact and therefore, which environment was more conducive to learning how to suture.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Results publication: PubMed 28562455Roussin CJ, Weinstock P. SimZones: An Organizational Innovation for Simulation Programs and Centers. Acad Med. 2017 Aug;92(8):1114-1120. doi: 10.1097/ACM.0000000000001746.
- Results publication: PubMed 28984729Jagneaux T, Caffery TS, Musso MW, Long AC, Zatarain L, Stopa E, Freeman N, Quin CC, Jones GN. Simulation-Based Education Enhances Patient Safety Behaviors During Central Venous Catheter Placement. J Patient Saf. 2021 Sep 1;17(6):425-429. doi: 10.1097/PTS.0000000000000425.
- Results publication: PubMed 28109296Sorensen JL, Ostergaard D, LeBlanc V, Ottesen B, Konge L, Dieckmann P, Van der Vleuten C. Design of simulation-based medical education and advantages and disadvantages of in situ simulation versus off-site simulation. BMC Med Educ. 2017 Jan 21;17(1):20. doi: 10.1186/s12909-016-0838-3.
- Results publication: PubMed 26861702Ullman E, Kennedy M, Di Delupis FD, Pisanelli P, Burbui AG, Cussen M, Galli L, Pini R, Gensini GF. The Tuscan Mobile Simulation Program: a description of a program for the delivery of in situ simulation training. Intern Emerg Med. 2016 Sep;11(6):837-41. doi: 10.1007/s11739-016-1401-2. Epub 2016 Feb 9.
- Results publication: PubMed 26152493Haji FA, Rojas D, Childs R, de Ribaupierre S, Dubrowski A. Measuring cognitive load: performance, mental effort and simulation task complexity. Med Educ. 2015 Aug;49(8):815-27. doi: 10.1111/medu.12773.
- Results publication: PubMed 23280527Rosen MA, Hunt EA, Pronovost PJ, Federowicz MA, Weaver SJ. In situ simulation in continuing education for the health care professions: a systematic review. J Contin Educ Health Prof. 2012 Fall;32(4):243-54. doi: 10.1002/chp.21152.
- Results publication: PubMed 27748042Petrosoniak A, Auerbach M, Wong AH, Hicks CM. In situ simulation in emergency medicine: Moving beyond the simulation lab. Emerg Med Australas. 2017 Feb;29(1):83-88. doi: 10.1111/1742-6723.12705. Epub 2016 Oct 17.
- Results publication: PubMed 26152492Naismith LM, Cheung JJ, Ringsted C, Cavalcanti RB. Limitations of subjective cognitive load measures in simulation-based procedural training. Med Educ. 2015 Aug;49(8):805-14. doi: 10.1111/medu.12732.
- Individual participant dataSharing planned: No
Related trials for Sutured Laceration
Recruiting
This is a Study to Verify if Marrow Venting Procedure Can Improve Meniscal Suture Healing
Meniscal Tear
RecruitingObservational study
Zimmer ActivBraid Rotator Cuff Repair (RCR) Study
Rotator Cuff Repair of the Shoulder
RecruitingObservational study
Evaluation of Survival and Clinical Outcomes of Patients Treated With Isolated All-inside Meniscal Sutures or With Meniscal Sutures Associated With Ligament Reconstruction
Suture, Complication, Ligament Laceration
Not yet recruiting
Patient Satisfaction and Cosmetic Outcomes in Adhesive Strip Versus Suture Repair for Simple Facial Lacerations
Facial Laceration
RecruitingObservational study
Clinical and Instrumental Assessment of Meniscal ROOT Tears Treated Through Suture to the Posterior Cruciate Ligament
Meniscus Tear, Meniscus Lesion
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.
Chrystal Horwood, MD principal investigator
Memorial University of Newfoundland and Labrador
Questions about this trial
What is this clinical trial studying?
A study testing Simulated Learning Environment in people with Sutured Laceration and Laceration, run by Memorial University of Newfoundland.
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 2 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: withdrawn, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
How each simulated learning environment effects a student's ability to learn how to suture (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03499002, which also lists 8 linked publications.
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 13 Mar 2019.