Surgical Simulation EducationNCT07820345
Development and Evaluation of Low-Cost Non-Animal Biological Simulation Models for Undergraduate Surgical Training in Trauma Tissue Reconstruction
A study testing Suturing Simulation Training and Tendon Repair Simulation Training in people with Surgical Simulation Education, run by All India Institute of Medical Sciences at 1 site in India.
Trial summary
This study evaluated two low-cost, non-animal biological simulation models for teaching basic surgical skills to undergraduate medical students. Banana peel was used as a model for practicing interrupted skin suturing, and rose stem was used as a model for practicing Modified Kessler tendon repair. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Surgical Simulation Education
- What is being tested?
- Suturing Simulation Training and Tendon Repair Simulation Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteIndia
- Study dates
- 27 May 2025to 27 Aug 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
- Eligible participants were first- and second-year MBBS undergraduate students at AIIMS New Delhi who voluntarily consented to participate
- were available for the full training and assessment schedule
Who cannot join
- prior advanced surgical or simulation training
- any current disabling upper limb injury or severe tremor
- unwillingness to participate.
Trial locations and contacts
1 site in 1 country.
India1 site
SET Facility, AIIMS Delhi
Delhi, National Capital Territory of Delhi, 110029
About this study
Official title: Development and Evaluation of Low-Cost Non-Animal Biological Simulation Models for Undergraduate Surgical Training in Trauma Tissue Reconstruction: A Randomized Controlled Study
This study evaluated two low-cost, non-animal biological simulation models for teaching basic surgical skills to undergraduate medical students. Banana peel was used as a model for practicing interrupted skin suturing, and rose stem was used as a model for practicing Modified Kessler tendon repair. Each plant-based model was compared with a commercially available simulation model.
The study was designed to determine whether these low-cost biological models could be used for surgical skills training and to assess technical performance, learner experience, and material costs associated with the different simulation models. Participants were randomly assigned to practice using either the plant-based model or the corresponding commercial simulator.
The study hypothesis was that the non-animal biological models would provide training outcomes and learner satisfaction comparable to commercial simulation models while requiring substantially lower material costs.
Read the detailed description
Surgical simulation provides undergraduate medical students with an opportunity to develop basic operative skills in a controlled environment before performing procedures on patients. However, commercially available simulation models may be costly, particularly when repeated practice is required for large groups of students or in resource-limited educational settings.
This prospective, parallel-group randomized controlled study was conducted over three months from June to August 2025 in the Department of Burns, Plastic \& Maxillofacial Surgery at the All India Institute of Medical Sciences (AIIMS), New Delhi, India. Institutional Ethics Committee approval was obtained before participant recruitment (IEC-AIIMSA3409, dated 27 March 2025), and written informed consent was obtained from all participants.
The study evaluated two plant-based, non-animal biological simulation models and compared each with a corresponding commercial simulator. For suturing training, semi-ripe banana peel was prepared to simulate a superficial skin laceration and was compared with a commercially available suture training pad. For tendon repair training, fresh rose stems obtained from discarded garden material were prepared to simulate a transverse tendon injury and were compared with silicone tubing. The models were prepared using standardized methods and dimensions.
Participants underwent standardized one-hour training sessions conducted by the same experienced instructor. Each session included an introductory teaching component, demonstration of the procedure, and supervised hands-on practice. Suturing training included needle loading, needle placement, knot tying, and wound-edge approximation using interrupted sutures. Tendon repair training involved alignment of the transected model ends followed by performance of a Modified Kessler core suture using instrument-tied square knots. The same surgical instruments were used across the respective study groups.
A total of 45 first- and second-year MBBS students were enrolled. Participants were assigned to the suturing or tendon-repair training arm and were randomly allocated within each arm to either the plant-based biological model or the corresponding commercial simulator. Randomization was performed by drawing numbered lots from a sealed container by a research assistant who was not involved in training or assessment.
Technical performance was assessed using procedure-specific assessment checklists developed according to the Objective Structured Assessment of Technical Skills (OSATS) framework. Learner feedback regarding the training experience was collected using an 11-item, 5-point Likert-scale questionnaire. Participants also provided self-reported assessments of their skills before and after training. Direct material costs of the simulation models were recorded for comparison; reusable surgical instruments were common to the groups and were excluded from the material-cost comparison.
The study was designed to compare the technical performance, learner experience, and material requirements of plant-based biological simulation models with commercially available simulation models for basic suturing and tendon-repair training. The findings were intended to inform the potential use of accessible, low-cost, non-animal materials in undergraduate surgical skills education, particularly in settings where conventional simulation resources may be limited.
- Conditions
- Surgical Simulation Education
- Being tested
- Suturing Simulation Training, Tendon Repair Simulation Training
- Keywords
- surgical simulation, banana peel, OSATS, NON ANIMAL MODELS, Randomised control trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suturing Simulation TrainingOther
Standardized training in interrupted skin suturing using either a semi-ripe banana peel model or a commercially available suture training pad. The suturing procedure included needle loading, needle entry, appropriate bite depth, knot tying, knot security, wound-edge eversion, and appropriate suture spacing.
Tendon Repair Simulation TrainingOther
Standardized training in Modified Kessler tendon repair using either a fresh rose stem model or commercial silicone tubing. The procedure included alignment of the transected model ends, grasp placement, needle entry, core suture placement, knot tying, and assessment of repair integrity.
| Study group | Role | What they receive |
|---|---|---|
| Suturing Arm | Other | Participants underwent standardized training in interrupted skin suturing using either a semi-ripe banana peel model or a commercially available suture training pad. The training consisted of instruction, demonstration, and supervised hands-on practice. Participants were randomly allocated to the simulation model within the suturing training arm. Receives: Other: Suturing Simulation Training |
| Tendon Repair | Other | Participants underwent standardized training in Modified Kessler tendon repair using either a fresh rose stem model or commercial silicone tubing. The training consisted of instruction, demonstration, and supervised hands-on practice. Participants were randomly allocated to the simulation model within the tendon repair training arm. Receives: Other: Tendon Repair Simulation Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suturing Technical Proficiency - OSATS Score
Technical proficiency in skin suturing was assessed using an 8-item procedure-specific checklist developed according to the Objective Structured Assessment of Technical Skills (OSATS) framework. Each item was scored according to predefined criteria. The total score ranges from 0 to 8, with higher scores indicating better technical performance.
Measured: Immediately after completion of the suturing training session
Tendon Repair Technical Proficiency - OSATS Score
Technical proficiency in tendon repair was assessed using a 9-item procedure-specific checklist developed according to the Objective Structured Assessment of Technical Skills (OSATS) framework. Each item was scored according to predefined criteria. The total score ranges from 0 to 9, with higher scores indicating better technical performance.
Measured: Immediately after completion of the tendon repair training session
Secondary outcomes (3)
Learner Feedback Survey Score
Learner experience was assessed using an 11-item, 5-point Likert-scale questionnaire covering training clarity, instructor guidance, model realism, procedural confidence, and overall satisfaction. The total score ranges from 11 to 55, with higher scores indicating more positive learner feedback.
Measured: Immediately after completion of the training session
Self-Reported Pre- and Post-Training Skill Score
Participants self-assessed their perceived surgical skill using a numerical rating scale ranging from 0 to 10. Skill scores were recorded immediately before and immediately after the training session. Higher scores indicate greater self-perceived skill.
Measured: Immediately before and immediately after the training session
Direct Material Cost per Simulation Model
The direct material cost required to prepare one simulation model was recorded for each study group. Costs were calculated in Indian Rupees (INR) based on the materials required to prepare each model. Reusable surgical instruments were common to all groups and were excluded from the cost calculation. Lower cost represents lower material expenditure.
Measured: Immediately after preparation of the simulation models
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start27 May 2025
- Primary completion27 Aug 2025
- Study completion27 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Simulation EducationStudies 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tanmay Gupta, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07820345
- Sponsor's protocol ID
- IEC-AIIMSA3409
- Status last verified
- Sep 2026
- First submitted
- 21 Jul 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared due to the small sample size, which could compromise participant anonymity. Anonymized summary data are available from the corresponding author on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of Low-Cost Non-Animal Biological Simulation Models for Undergraduate Surgical Training in Trauma Tissue Reconstruction: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07820345
- Acronym / sponsor ID
- IEC-AIIMSA3409
- Conditions
- Surgical Simulation Education
- Keywords
- surgical simulation, banana peel, OSATS, NON ANIMAL MODELS, Randomised control trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- 27 May 2025 (actual)
- Primary completion
- 27 Aug 2025 (actual)
- Study completion
- 27 Aug 2025 (actual)
- First posted
- 15 Sep 2026 (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.
This study evaluated two low-cost, non-animal biological simulation models for teaching basic surgical skills to undergraduate medical students. Banana peel was used as a model for practicing interrupted skin suturing, and rose stem was used as a model for practicing Modified Kessler tendon repair. Each plant-based model was compared with a commercially available simulation model.
The study was designed to determine whether these low-cost biological models could be used for surgical skills training and to assess technical performance, learner experience, and material costs associated with the different simulation models. Participants were randomly assigned to practice using either the plant-based model or the corresponding commercial simulator.
The study hypothesis was that the non-animal biological models would provide training outcomes and learner satisfaction comparable to commercial simulation models while requiring substantially lower material costs.
Detailed description
Surgical simulation provides undergraduate medical students with an opportunity to develop basic operative skills in a controlled environment before performing procedures on patients. However, commercially available simulation models may be costly, particularly when repeated practice is required for large groups of students or in resource-limited educational settings.
This prospective, parallel-group randomized controlled study was conducted over three months from June to August 2025 in the Department of Burns, Plastic \& Maxillofacial Surgery at the All India Institute of Medical Sciences (AIIMS), New Delhi, India. Institutional Ethics Committee approval was obtained before participant recruitment (IEC-AIIMSA3409, dated 27 March 2025), and written informed consent was obtained from all participants.
The study evaluated two plant-based, non-animal biological simulation models and compared each with a corresponding commercial simulator. For suturing training, semi-ripe banana peel was prepared to simulate a superficial skin laceration and was compared with a commercially available suture training pad. For tendon repair training, fresh rose stems obtained from discarded garden material were prepared to simulate a transverse tendon injury and were compared with silicone tubing. The models were prepared using standardized methods and dimensions.
Participants underwent standardized one-hour training sessions conducted by the same experienced instructor. Each session included an introductory teaching component, demonstration of the procedure, and supervised hands-on practice. Suturing training included needle loading, needle placement, knot tying, and wound-edge approximation using interrupted sutures. Tendon repair training involved alignment of the transected model ends followed by performance of a Modified Kessler core suture using instrument-tied square knots. The same surgical instruments were used across the respective study groups.
A total of 45 first- and second-year MBBS students were enrolled. Participants were assigned to the suturing or tendon-repair training arm and were randomly allocated within each arm to either the plant-based biological model or the corresponding commercial simulator. Randomization was performed by drawing numbered lots from a sealed container by a research assistant who was not involved in training or assessment.
Technical performance was assessed using procedure-specific assessment checklists developed according to the Objective Structured Assessment of Technical Skills (OSATS) framework. Learner feedback regarding the training experience was collected using an 11-item, 5-point Likert-scale questionnaire. Participants also provided self-reported assessments of their skills before and after training. Direct material costs of the simulation models were recorded for comparison; reusable surgical instruments were common to the groups and were excluded from the material-cost comparison.
The study was designed to compare the technical performance, learner experience, and material requirements of plant-based biological simulation models with commercially available simulation models for basic suturing and tendon-repair training. The findings were intended to inform the potential use of accessible, low-cost, non-animal materials in undergraduate surgical skills education, particularly in settings where conventional simulation resources may be limited.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suturing Arm | Other | Other: Suturing Simulation TrainingParticipants underwent standardized training in interrupted skin suturing using either a semi-ripe banana peel model or a commercially available suture training pad. The training consisted of instruction, demonstration, and supervised hands-on practice. Participants were randomly allocated to the simulation model within the suturing training arm. |
| Tendon Repair | Other | Other: Tendon Repair Simulation TrainingParticipants underwent standardized training in Modified Kessler tendon repair using either a fresh rose stem model or commercial silicone tubing. The training consisted of instruction, demonstration, and supervised hands-on practice. Participants were randomly allocated to the simulation model within the tendon repair training arm. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Eligible participants were first- and second-year MBBS undergraduate students at AIIMS New Delhi who voluntarily consented to participate
- were available for the full training and assessment schedule
Key exclusion criteria (3 listed)
- prior advanced surgical or simulation training
- any current disabling upper limb injury or severe tremor
- unwillingness 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 |
|---|---|---|
| Suturing Simulation TrainingStandardized training in interrupted skin suturing using either a semi-ripe banana peel model or a commercially available suture training pad. The suturing procedure included needle loading, needle entry, appropriate bite depth, knot tying, knot security, wound-edge eversion, and appropriate suture spacing. | Other | Suturing Arm |
| Tendon Repair Simulation TrainingStandardized training in Modified Kessler tendon repair using either a fresh rose stem model or commercial silicone tubing. The procedure included alignment of the transected model ends, grasp placement, needle entry, core suture placement, knot tying, and assessment of repair integrity. | Other | Tendon Repair |
Primary outcome
Suturing Technical Proficiency - OSATS Score
Time frame: Immediately after completion of the suturing training session
Technical proficiency in skin suturing was assessed using an 8-item procedure-specific checklist developed according to the Objective Structured Assessment of Technical Skills (OSATS) framework. Each item was scored according to predefined criteria. The total score ranges from 0 to 8, with higher scores indicating better technical performance.
Tendon Repair Technical Proficiency - OSATS Score
Time frame: Immediately after completion of the tendon repair training session
Technical proficiency in tendon repair was assessed using a 9-item procedure-specific checklist developed according to the Objective Structured Assessment of Technical Skills (OSATS) framework. Each item was scored according to predefined criteria. The total score ranges from 0 to 9, with higher scores indicating better technical performance.
3 secondary outcomes
Learner Feedback Survey Score
Time frame: Immediately after completion of the training session
Self-Reported Pre- and Post-Training Skill Score
Time frame: Immediately before and immediately after the training session
Direct Material Cost per Simulation Model
Time frame: Immediately after preparation of the simulation models
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 15 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared due to the small sample size, which could compromise participant anonymity. Anonymized summary data are available from the corresponding author on reasonable request
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Simulation Training and Tendon Repair Simulation Training in people with Surgical Simulation Education, run by All India Institute of Medical Sciences at 1 site in India.
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 3 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 15 Sep 2026. 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 India. 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?
Suturing Technical Proficiency - OSATS Score (time frame: Immediately after completion of the suturing training session). The study lists 2 primary outcomes in all. 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 2026.