- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07820345
Development and Evaluation of Low-Cost Non-Animal Biological Simulation Models for Undergraduate Surgical Training in Trauma Tissue Reconstruction
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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National Capital Territory of Delhi
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Delhi, National Capital Territory of Delhi, India, 110029
- SET Facility, AIIMS Delhi
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- 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
Exclusion Criteria:
- prior advanced surgical or simulation training
- any current disabling upper limb injury or severe tremor
- unwillingness to participate.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Otro: Suturing Arm
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.
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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.
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Otro: Tendon Repair
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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Suturing Technical Proficiency - OSATS Score
Periodo de tiempo: Immediately after completion of the suturing training session
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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.
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Immediately after completion of the suturing training session
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Tendon Repair Technical Proficiency - OSATS Score
Periodo de tiempo: Immediately after completion of the tendon repair training session
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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.
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Immediately after completion of the tendon repair training session
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Learner Feedback Survey Score
Periodo de tiempo: Immediately after completion of the training session
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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.
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Immediately after completion of the training session
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Self-Reported Pre- and Post-Training Skill Score
Periodo de tiempo: Immediately before and immediately after the training session
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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.
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Immediately before and immediately after the training session
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Direct Material Cost per Simulation Model
Periodo de tiempo: Immediately after preparation of the simulation models
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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.
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Immediately after preparation of the simulation models
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- IEC-AIIMSA3409
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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