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

2026年9月9日 更新者:Tanmay Gupta、All India Institute of Medical Sciences

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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

45

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • National Capital Territory of Delhi
      • Delhi、National Capital Territory of Delhi、インド、110029
        • SET Facility, AIIMS Delhi

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:他の
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
他の: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.
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.
他の: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.
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Suturing Technical Proficiency - OSATS Score
時間枠: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.
Immediately after completion of the suturing training session
Tendon Repair Technical Proficiency - OSATS Score
時間枠: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.
Immediately after completion of the tendon repair training session

二次結果の測定

結果測定
メジャーの説明
時間枠
Learner Feedback Survey Score
時間枠:Immediately after completion of the training session
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.
Immediately after completion of the training session
Self-Reported Pre- and Post-Training Skill Score
時間枠:Immediately before and immediately after the training session
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.
Immediately before and immediately after the training session
Direct Material Cost per Simulation Model
時間枠:Immediately after preparation of the simulation models
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.
Immediately after preparation of the simulation models

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年5月27日

一次修了 (実際)

2025年8月27日

研究の完了 (実際)

2025年8月27日

試験登録日

最初に提出

2026年7月21日

QC基準を満たした最初の提出物

2026年9月9日

最初の投稿 (実際)

2026年9月15日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月15日

QC基準を満たした最後の更新が送信されました

2026年9月9日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • IEC-AIIMSA3409

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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