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临床试验/NCT07820345
NCT07820345已完成不适用

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

All India Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2025年5月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
1
主要终点
Suturing Technical Proficiency - OSATS Score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

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.

干预措施: Suturing Simulation Training (Other)

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.

干预措施: Tendon Repair Simulation Training (Other)

结局指标

主要结局

Suturing Technical Proficiency - OSATS Score

时间窗: 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

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tanmay Gupta

MBBS Intern

All India Institute of Medical Sciences

研究点 (1)

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