Development and Evaluation of Low-Cost Non-Animal Biological Simulation Models for Undergraduate Surgical Training in Trauma Tissue Reconstruction

NCT07820345 | Completed

• 1 other identifier: IEC-AIIMSA3409
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Surgical Simulation Education

Keywords

surgical simulation; banana peel; OSATS; NON ANIMAL MODELS; Randomised control trial

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Immediately after completion of the tendon repair training session

Secondary Outcomes (3)

• Learner Feedback Survey Score

  Immediately after completion of the training session

• Self-Reported Pre- and Post-Training Skill Score

  Immediately before and immediately after the training session

• Direct Material Cost per Simulation Model

  Immediately after preparation of the simulation models

Study Arms (2)

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.

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.

Other: Tendon Repair Simulation Training

Interventions

Suturing Simulation Training OTHER

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.

Suturing Arm

Tendon Repair Simulation Training OTHER

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.

Tendon Repair

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• prior advanced surgical or simulation training
• any current disabling upper limb injury or severe tremor
• unwillingness to participate.

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

SET Facility, AIIMS Delhi

Delhi, National Capital Territory of Delhi, 110029, India

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MBBS Intern

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: September 15, 2026
• Study Start: May 27, 2025
• Primary Completion: August 27, 2025
• Study Completion: August 27, 2025
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)