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临床试验/CTRI/2024/07/071422
CTRI/2024/07/071422尚未招募不适用

Assessment Of Antimicrobial Prophylaxis And Incidence Of Surgical Site Infection Among Surgical Patients In A Tertiary Care Hospital

未提供1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年8月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
150
试验地点
1
主要终点
The study helps to identify the compliance with surgical antimicrobial prophylaxis

研究概览

简要总结

INTRODUCTION

Surgical site infections (SSIs) are infections associated with surgeries occurring within 30 days of a surgical incision or 90 days after a prosthetic material implantation. SSI can be effectively prevented by administering proper Surgical Antimicrobial Prophylaxis (SAP) therapy. With this background, the current study aims to evaluate SAP, assess the incidence of SSI, and various factors with SSI. Thus, the study is conducted to assess SAP and the incidence rate of SSI.

OBJECTIVE

To assess the compliance with surgical antibiotic prophylaxis, the incidence of Surgical site infection, and the factors associated with it.

JUSTIFICATION OF THE STUDY

From the literature evidence it is understood that the adherence to the SAP is low and the incidence of SSI is high, this can increase the treatment cost and affect the patient’s quality of life. So, the current study aims to assess SAP practices and the incidence rate of SSIs.

METHODOLOGY

A prospective cross-sectional study will be conducted in the Department of Surgery, Justice K.S. Hegde Charitable Hospital with 150 patients (The sample size was calculated based on a 5% level of significance and considering 8% absolute precision) for 8 months. Patients aged 18 years and above with clean, clean contaminated, and contaminated types of wounds will be included in the study. Patients with dirty/ infected wounds, pregnant women cancer, and psychiatric patients will be excluded from the study. The study subjects will be enrolled after obtaining written consent. The study parameters include antimicrobial prophylaxis (as per WHO guidelines), incidence of surgical site infection and associated factors. The collected data will be documented electronically in Microsoft Excel 2019 and statistically analyzed using SPSS version 29.

STATISTICAL ANALYSIS

Categorical data will be expressed as frequency and percentage SPSS version 29 will be used for statistical analysis.

OUTCOME MEASURES

The study helps in identifying the compliance with SAP and its incidence of SSI. The study identifies various factors associated with SSI.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients aged 18 years and above with clean, clean contaminated, and contaminated types of wounds will be included in the study.

排除标准

  • Patients with dirty/ infected wounds, pregnant women cancer, and psychiatric patients will be excluded from the study.

结局指标

主要结局

The study helps to identify the compliance with surgical antimicrobial prophylaxis

时间窗: 8 months

次要结局

  • To identify the incidence of surgical site infection(8 months)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Aswathi C

NGSM Institute of Pharmaceutical Sciences

研究点 (1)

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