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.