Comparison of Clinical Efficacy and Safety of Amnio-Graft Versus Skin Graft in Injury Patients: Retrospective Cohort Study

Al Mujtahid Hospital, Damascus, Syria Title of the Study: Comparison of Clinical Efficacy and Safety of Amnio-Graft versus Skin Graft in Plastic Surgery Principal Investigator: Dr. Wael Barazi, President of the Plastic Surgery Department Study Duration: From February 19, 2023, to October 23, 2023 I. Background and Rationale: Plastic surgery, a rapidly evolving field, continuously explores novel techniques to enhance patient outcomes. This retrospective cohort study aims to compare the clinical efficacy and safety of amnio-graft and skin graft procedures performed in the Plastic Surgery Department of Al Mujtahid Hospital in Damascus, Syria. II. Objectives: To assess the clinical efficacy of amnio-graft and skin graft procedures. To evaluate the safety profile of amnio-graft and skin graft procedures. To compare the outcomes of patients undergoing plastic surgery with amnio-graft versus skin graft. III. Study Design: This study will adopt a retrospective cohort design, analyzing data collected from patient records in the Plastic Surgery Department during the specified study duration. IV. Participants: The study will include all patients who underwent either amnio-graft or skin graft procedures within the defined study period. V. Data Collection: Primary Data: Patient demographics Preoperative clinical characteristics Surgical details Postoperative outcomes Adverse events Secondary Data: Histopathological findings Follow-up information Hospitalization duration Any additional relevant clinical information VI. Data Analysis: Statistical analysis will be conducted to compare clinical outcomes and safety profiles between the amnio-graft and skin graft groups. Descriptive statistics, such as mean, median, and standard deviation, will be used, and inferential statistics, including chi-square tests and t-tests, will be applied where appropriate. VII. Ethical Considerations: Patient Confidentiality: All patient information will be kept confidential, with data anonymized during analysis. Informed Consent: As this is a retrospective study, no new interventions will be performed. Informed consent will not be obtained. Patient Welfare: Patient welfare and safety are paramount. The study design aims to minimize risks associated with data collection. VIII. Potential Risks and Benefits: Risks: There are no additional risks associated with this retrospective study as it involves the analysis of existing medical records. Benefits: The study results may contribute to improved decision-making in plastic surgery procedures, enhancing patient outcomes. IX. Approval: This research protocol has been reviewed and approved by the Institutional Review Board (IRB) of Al Mujtahid Hospital. IRB Approval Date: [27/11/2023] IRB Approval Code: [63211] Note: Any amendments to this protocol will require additional review and approval by the Institutional Review Board.叙利亚大马士革阿尔穆吉塔希德医院 研究标题：整形外科中羊膜移植（Amnio-Graft）与皮肤移植（Skin Graft）的临床疗效与安全性对比研究 主要研究者：瓦埃尔·巴拉齐（Wael Barazi）博士，整形外科主任 研究周期：2023年2月19日至2023年10月23日 一、研究背景与理论依据 整形外科是一门快速发展的学科，持续探索新型技术以改善患者预后。本回顾性队列研究旨在对比叙利亚大马士革阿尔穆吉塔希德医院整形外科开展的羊膜移植（Amnio-Graft）与皮肤移植（Skin Graft）手术的临床疗效与安全性。 二、研究目标 1. 评估羊膜移植与皮肤移植手术的临床疗效； 2. 评价两种移植手术的安全性概况； 3. 对比接受羊膜移植与皮肤移植的整形外科患者的预后情况。 三、研究设计 本研究采用回顾性队列研究设计，分析指定研究周期内整形外科患者病历中的相关数据。 四、研究对象 本研究纳入在规定研究周期内接受羊膜移植或皮肤移植手术的所有患者。 五、数据采集 主要数据： 患者人口统计学信息、术前临床特征、手术细节、术后结局、不良事件。 次要数据： 组织病理学检查结果、随访信息、住院时长、其他相关临床信息。 六、数据分析 将开展统计学分析以对比羊膜移植组与皮肤移植组的临床结局及安全性概况。将使用描述性统计方法（如均值、中位数与标准差），并在适宜场景下应用推断性统计方法，包括卡方检验与t检验。 七、伦理考量 患者隐私保护： 所有患者信息将严格保密，分析过程中将对数据进行匿名化处理。 知情同意： 由于本研究为回顾性研究，无需开展新的临床干预措施，因此无需获取患者知情同意。 患者福祉： 患者福祉与安全是首要考量因素，本研究设计旨在将数据采集相关的风险降至最低。 八、潜在风险与获益 风险： 本研究仅涉及现有病历数据分析，不存在额外研究相关风险。 获益： 本研究结果有助于优化整形外科手术的临床决策，进而改善患者预后。 九、伦理审批 本研究方案已通过阿尔穆吉塔希德医院机构审查委员会（Institutional Review Board, IRB）的审核与批准。 机构审查委员会审批日期：[2023年11月27日] 机构审查委员会审批编号：[63211] 备注：本研究方案的任何修订均需提交机构审查委员会进行额外审核与批准。