Suture TechniquesRCTNCT07038525
Online vs. In-Person Suturing Training: A Non-Inferiority Randomized Controlled Trial in a Low-Resource Setting
A study testing Suturing training in people with Suture Techniques and Training Effectiveness, run by Diala Burjak at 1 site in Jordan.
Trial summary
The goal of this clinical trial is to assess whether online suturing training is non-inferior to in-person training in developing suturing skills among medical students at Yarmouk University in a low-resource setting. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Suture Techniques, Training Effectiveness, Online Education
- What is being tested?
- Suturing training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteJordan
- Study dates
- 13 May 2025to 17 May 2025
- 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
- Medical students (Yarmouk university)
- Signed informed consent
Who cannot join
- Incomplete workshop attendance
- Technical issues that hinder full participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Non-Inferiority Randomized Controlled Trial Comparing the Effectiveness of Online Versus In-Person Suturing Training Among Medical Students in a Low Resource Setting
The goal of this clinical trial is to assess whether online suturing training is non-inferior to in-person training in developing suturing skills among medical students at Yarmouk University in a low-resource setting.
The main questions it aims to answer are:
Read more
- Is online suturing training as effective as in-person training in developing practical skills (as measured by OSATS scores)?
- Does online training result in comparable knowledge improvement compared to in-person training (as measured by MCQ scores)?
Researchers will compare the online video-based training with Zoom feedback to live instructor-led in-person training to see if the online approach is not clinically inferior in terms of skills and knowledge acquisition.
Participants will:
- Complete pre-assessment and informed consent
- Be randomly assigned to one of the two training groups using stratified block randomization
- Participate in a suturing workshop either in-person or via online video and Zoom feedback
- Complete a post-assessment including OSATS-evaluated performance and MCQ test
Allocation concealment will be maintained, and the OSATS scores will be assessed by a blinded evaluator using a standardized checklist.
Read the detailed description
This randomized controlled trial aims to evaluate the effectiveness of online versus in-person suturing training among medical students in a low-resource setting. Suturing is a core skill expected of medical students and a critical component of surgical training. With increasing demand for flexible and accessible medical education, online learning platforms have gained popularity. However, the comparative effectiveness of virtual training versus traditional in-person instruction in delivering procedural skills remains underexplored, particularly in low-resource environments.
This trial is designed as a phase II, parallel-group, non-inferiority randomized controlled trial with stratified block randomization and blinded outcome assessment. The goal is to determine whether online video-based suturing instruction, supplemented with real-time feedback via Zoom, is non-inferior to traditional in-person training in achieving technical skill acquisition, as measured by the Objective Structured Assessment of Technical Skills (OSATS).
Study participants are pre-clinical and clinical medical students from Yarmouk University who voluntarily consent to participate and complete all phases of the study. Participants will be stratified based on prior suturing experience (Yes/No) and randomly assigned in blocks of 4 or 6 to ensure balanced distribution across both training arms.
Allocation concealment is preserved through a standardized process: participants provide informed consent and complete baseline assessments before group assignment is revealed. The intervention is delivered in one of two formats, with both groups using identical suturing kits and standardized instructional material to reduce variability.
The in-person group receives live instructor-led training during a hands-on session.
The online group receives a pre-recorded instructional video and practices independently using the kit, followed by live Zoom-based feedback from a trainer.
Following the intervention, all participants are assessed via two primary methods:
- OSATS checklist, completed by a blinded evaluator based on video recordings of each participant's performance.
- Knowledge assessment, consisting of a five-question multiple choice test administered before and after the training to measure knowledge gain.
The OSATS tool used is a standardized and validated checklist evaluating multiple technical domains such as instrument handling, suture technique, and tissue approximation. The total OSATS score, which ranges based on the number of checklist items scored on a 1-5 scale, serves as the primary outcome. Knowledge scores (0-5) serve as the secondary outcome.
Statistical analysis will follow a pre-specified non-inferiority framework. Normality of score distributions will be assessed using Shapiro-Wilk tests. If assumptions are met, independent t-tests and 95% confidence intervals will be used to assess non-inferiority; if not, non-parametric alternatives (e.g., Mann-Whitney U tests) will be used. Sensitivity analyses will confirm robustness of findings using both parametric and non-parametric approaches. Within-group changes in knowledge scores will be analyzed using paired t-tests or Wilcoxon signed-rank tests, as appropriate.
To reduce potential bias, evaluator blinding is strictly maintained and only one evaluator is used to eliminate inter-rater variability. The use of standardized materials, identical kits, and consistent checklists across both groups ensures fairness and fidelity to protocol.
This study will serve as a pilot non-inferiority trial, intended to generate effect size estimates and assess the feasibility of larger-scale implementation in similar low-resource environments. While the planned sample size of 48 participants (24 per arm) may not detect moderate effect sizes with high power, it is sufficient to detect large differences and inform the design of future trials.
The broader educational aim of this trial is to provide insight into how surgical education can be adapted to virtual or remote learning formats without compromising quality, especially in regions where traditional instruction is limited by geographic, financial, or institutional constraints. Results may inform both local and international medical education strategies and support the development of cost-effective, scalable solutions to procedural training.
This project is conducted under the Live Your Dream (LYD) educational initiative and is fully self-funded by the investigator. No external funding or institutional sponsorship has been obtained. Results will be disseminated through academic conferences and peer-reviewed publication.
- Conditions
- Suture Techniques, Training Effectiveness, Online Education, Student Education, Hands-on Training
- Being tested
- Suturing training
- Keywords
- suturing skills, surgical education, online medical training, hands-on workshop, medical student, simulation-based learning, OSATS, low-resource setting, RCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suturing trainingOther
Also called Suturing skills workshop
This intervention involves basic suturing skills training delivered either in-person or online. In the in-person group, participants receive live instruction and hands-on supervision. In the online group, participants watch a standardized video tutorial and receive remote feedback via Zoom. All participants use identical suturing kits and are evaluated using the same OSATS checklist by a blinded assessor. The content and learning objectives are standardized across both formats.
| Study group | Role | What they receive |
|---|---|---|
| In person suturing training | Experimental | Participants in this arm will attend a live, instructor-led suturing training session using standardized kits. The session will involve hands-on practice under direct supervision. The curriculum and assessment criteria are consistent with the online arm to ensure parity in instructional content. Receives: Other: Suturing training |
| Online suturing training | Experimental | Participants in this arm will receive access to a pre-recorded instructional video and practice independently using identical kits. After completing the training, participants will receive real-time feedback via Zoom from a trainer. Instructional content and assessment tools are standardized across both groups. Receives: Other: Suturing training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total OSATS Score (Objective Structured Assessment of Technical Skills)
The OSATS score will assess practical suturing skills using a standardized checklist across multiple domains (e.g., instrument handling, suture technique, knot tying). Each item is scored on a 1-5 ordinal scale, and scores are summed to create a total OSATS score. The evaluation will be conducted by a blinded assessor based on video recordings. The total score will be treated as a continuous variable if normality is satisfied and will serve as the primary outcome in assessing non-inferiority between the online and in-person training groups.
Measured: Within 2 days post-intervention
Secondary outcomes (1)
Knowledge Assessment Score (Pre/Post MCQ)
Participants will complete a five-question multiple choice test before and after the suturing training. Each question is scored as correct (1) or incorrect (0), with a total score ranging from 0 to 5. This outcome evaluates knowledge acquisition related to suturing principles and techniques. Group differences in post-test scores, as well as within-group pre-post improvement, will be analyzed using appropriate statistical tests based on distribution.
Measured: Immediately before and after intervention (3 days total)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start13 May 2025
- Primary completion17 May 2025
- Study completion17 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suture TechniquesStudies 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
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diala Burjak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Diala Burjak, Yarmouk University
- Investigators
- Diala Burjak, MD, Principal investigator, NYC Health + Hospitals/ Elmhurst Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038525
- Sponsor's protocol ID
- LYD-RCT001
- Acronym
- RCT
- Status last verified
- May 2025
- First submitted
- 16 May 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that will be shared include OSATS scores, pre- and post-intervention knowledge assessment scores, and basic demographic information (age, gender, clinical year, prior suturing experience). Data will be shared for academic research purposes upon reasonable request following publication of the main results. No personally identifiable information will be included. Access requests should be submitted to the Principal Investigator via email.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Inferiority Randomized Controlled Trial Comparing the Effectiveness of Online Versus In-Person Suturing Training Among Medical Students in a Low Resource Setting
- ClinicalTrials.gov ID
- NCT07038525
- Acronym / sponsor ID
- RCT / LYD-RCT001
- Conditions
- Suture Techniques, Training Effectiveness, Online Education, Student Education, Hands-on Training
- Keywords
- suturing skills, surgical education, online medical training, hands-on workshop, medical student, simulation-based learning, OSATS, low-resource setting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Diala BurjakUniversity, hospital or other
- Study start
- 13 May 2025 (actual)
- Primary completion
- 17 May 2025 (actual)
- Study completion
- 17 May 2025 (actual)
- First posted
- 26 Jun 2025 (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 goal of this clinical trial is to assess whether online suturing training is non-inferior to in-person training in developing suturing skills among medical students at Yarmouk University in a low-resource setting.
The main questions it aims to answer are:
- Is online suturing training as effective as in-person training in developing practical skills (as measured by OSATS scores)?
- Does online training result in comparable knowledge improvement compared to in-person training (as measured by MCQ scores)?
Researchers will compare the online video-based training with Zoom feedback to live instructor-led in-person training to see if the online approach is not clinically inferior in terms of skills and knowledge acquisition.
Participants will:
- Complete pre-assessment and informed consent
- Be randomly assigned to one of the two training groups using stratified block randomization
- Participate in a suturing workshop either in-person or via online video and Zoom feedback
- Complete a post-assessment including OSATS-evaluated performance and MCQ test
Allocation concealment will be maintained, and the OSATS scores will be assessed by a blinded evaluator using a standardized checklist.
Detailed description
This randomized controlled trial aims to evaluate the effectiveness of online versus in-person suturing training among medical students in a low-resource setting. Suturing is a core skill expected of medical students and a critical component of surgical training. With increasing demand for flexible and accessible medical education, online learning platforms have gained popularity. However, the comparative effectiveness of virtual training versus traditional in-person instruction in delivering procedural skills remains underexplored, particularly in low-resource environments.
This trial is designed as a phase II, parallel-group, non-inferiority randomized controlled trial with stratified block randomization and blinded outcome assessment. The goal is to determine whether online video-based suturing instruction, supplemented with real-time feedback via Zoom, is non-inferior to traditional in-person training in achieving technical skill acquisition, as measured by the Objective Structured Assessment of Technical Skills (OSATS).
Study participants are pre-clinical and clinical medical students from Yarmouk University who voluntarily consent to participate and complete all phases of the study. Participants will be stratified based on prior suturing experience (Yes/No) and randomly assigned in blocks of 4 or 6 to ensure balanced distribution across both training arms.
Allocation concealment is preserved through a standardized process: participants provide informed consent and complete baseline assessments before group assignment is revealed. The intervention is delivered in one of two formats, with both groups using identical suturing kits and standardized instructional material to reduce variability.
The in-person group receives live instructor-led training during a hands-on session.
The online group receives a pre-recorded instructional video and practices independently using the kit, followed by live Zoom-based feedback from a trainer.
Following the intervention, all participants are assessed via two primary methods:
- OSATS checklist, completed by a blinded evaluator based on video recordings of each participant's performance.
- Knowledge assessment, consisting of a five-question multiple choice test administered before and after the training to measure knowledge gain.
The OSATS tool used is a standardized and validated checklist evaluating multiple technical domains such as instrument handling, suture technique, and tissue approximation. The total OSATS score, which ranges based on the number of checklist items scored on a 1-5 scale, serves as the primary outcome. Knowledge scores (0-5) serve as the secondary outcome.
Statistical analysis will follow a pre-specified non-inferiority framework. Normality of score distributions will be assessed using Shapiro-Wilk tests. If assumptions are met, independent t-tests and 95% confidence intervals will be used to assess non-inferiority; if not, non-parametric alternatives (e.g., Mann-Whitney U tests) will be used. Sensitivity analyses will confirm robustness of findings using both parametric and non-parametric approaches. Within-group changes in knowledge scores will be analyzed using paired t-tests or Wilcoxon signed-rank tests, as appropriate.
To reduce potential bias, evaluator blinding is strictly maintained and only one evaluator is used to eliminate inter-rater variability. The use of standardized materials, identical kits, and consistent checklists across both groups ensures fairness and fidelity to protocol.
This study will serve as a pilot non-inferiority trial, intended to generate effect size estimates and assess the feasibility of larger-scale implementation in similar low-resource environments. While the planned sample size of 48 participants (24 per arm) may not detect moderate effect sizes with high power, it is sufficient to detect large differences and inform the design of future trials.
The broader educational aim of this trial is to provide insight into how surgical education can be adapted to virtual or remote learning formats without compromising quality, especially in regions where traditional instruction is limited by geographic, financial, or institutional constraints. Results may inform both local and international medical education strategies and support the development of cost-effective, scalable solutions to procedural training.
This project is conducted under the Live Your Dream (LYD) educational initiative and is fully self-funded by the investigator. No external funding or institutional sponsorship has been obtained. Results will be disseminated through academic conferences and peer-reviewed publication.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In person suturing training | Experimental | Other: Suturing trainingParticipants in this arm will attend a live, instructor-led suturing training session using standardized kits. The session will involve hands-on practice under direct supervision. The curriculum and assessment criteria are consistent with the online arm to ensure parity in instructional content. |
| Online suturing training | Experimental | Other: Suturing trainingParticipants in this arm will receive access to a pre-recorded instructional video and practice independently using identical kits. After completing the training, participants will receive real-time feedback via Zoom from a trainer. Instructional content and assessment tools are standardized across both groups. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Medical students (Yarmouk university)
- Signed informed consent
Key exclusion criteria (2 listed)
- Incomplete workshop attendance
- Technical issues that hinder full participation
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 |
|---|---|---|
| Suturing trainingAlso: Suturing skills workshopThis intervention involves basic suturing skills training delivered either in-person or online. In the in-person group, participants receive live instruction and hands-on supervision. In the online group, participants watch a standardized video tutorial and receive remote feedback via Zoom. All participants use identical suturing kits and are evaluated using the same OSATS checklist by a blinded assessor. The content and learning objectives are standardized across both formats. | Other | In person suturing training, Online suturing training |
Primary outcome
Total OSATS Score (Objective Structured Assessment of Technical Skills)
Time frame: Within 2 days post-intervention
The OSATS score will assess practical suturing skills using a standardized checklist across multiple domains (e.g., instrument handling, suture technique, knot tying). Each item is scored on a 1-5 ordinal scale, and scores are summed to create a total OSATS score. The evaluation will be conducted by a blinded assessor based on video recordings. The total score will be treated as a continuous variable if normality is satisfied and will serve as the primary outcome in assessing non-inferiority between the online and in-person training groups.
1 secondary outcome
Knowledge Assessment Score (Pre/Post MCQ)
Time frame: Immediately before and after intervention (3 days total)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that will be shared include OSATS scores, pre- and post-intervention knowledge assessment scores, and basic demographic information (age, gender, clinical year, prior suturing experience). Data will be shared for academic research purposes upon reasonable request following publication of the main results. No personally identifiable information will be included. Access requests should be submitted to the Principal Investigator via email.
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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.
Diala Burjak, MD principal investigator
NYC Health + Hospitals/ Elmhurst Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suturing training in people with Suture Techniques and Training Effectiveness, run by Diala Burjak at 1 site in Jordan.
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 2 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: finished, as of the sponsor's last update on 26 Jun 2025. 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 Jordan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total OSATS Score (Objective Structured Assessment of Technical Skills) (time frame: Within 2 days post-intervention). 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 26 Jun 2025.