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临床试验/NCT06129773
NCT06129773已完成不适用

Comparison Of Outcome Of Antibiotic Coated Vicryl Vs Non-Coated Vicryl In Abdominal Fascial Closure After Laparotomy In Children

Muhammad Adeel Ashiq1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年11月1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
发起方
入组人数
100
试验地点
1
主要终点
Rate of surgical site infection

研究概览

简要总结

We are investigating outcome of antibiotic coated vicryl versus non coated vicryl in terms of rate of surgical site infection and lebgth of hospital stay in children after lalaprotomy for perforated viscera. total 100 patients will be taken and 50 in each group.

详细描述

Pneumoperitoneum is typically a surgical emergency, particularly in children and more than 90% of occurrences are caused by perforation of the gastrointestinal tract and other hollow viscera. Wound infections after abdominal surgery are still frequent types of nosocomial infections. Sutures can be a source of wound infection and dehisence due to bacterial adherence and colonization. Sutures coated with antibacterial agents have been developed in an attempt to reduce bacterial adherence and colonization of suture materials. The objective of the study is to compare the outcome of antibiotic coated vicryl versus non-coated vicryl in abdominal fascial closure after laparotomy in children in regards of surgical site infections. It will be a randomized controlled trial in which 100 patients admitted in Children Hospital Lahore will be included. Simple random sampling will be carried out. Informed written consent will be taken from patients' guardian. The patients will be divided into two groups (50 in each group). Group-A patients will undergo laparotomy closure with antibiotic coated vicryl while Group-B patient will experience non-coated vicryl in abdominal fascial closure. All patients will be examined on 3rd, 7th and 30th post-operative day for wound infection according to Southampton wound scoring system. Data will be collected through predesigned proforma, which will be entered and statistically analyzed using SPSS version 24.0. For quantitative variables mean and standard deviation will be calculated and for qualitative variables frequency and percentages will be calculated. Data will be presented in tables and graphs. Chi-square test will be used to estimate the association between qualitative variables. P-value <0.05 will be considered significant. It is expected that results of this study may be helpful for healthcare providers to provide appropriate treatment to the patients and to prevent them from wound related complications.

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 (Participant)

入排标准

年龄范围
4 Hours 至 15 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •• Children with pneumoperitoneum / perforated viscus
  • •Children aged 0 day to 15 years
  • •Both genders

排除标准

  • •• Malnourished children
  • •Children aged above 15 years
  • •Clean surgeries
  • •Low Hb level
  • •Parents unwilling to take part

研究组 & 干预措施

anti biotic coated group

Experimental

干预措施: antibiotic coated vicryl used for fascial closure (Procedure)

non coated group

No Intervention

结局指标

主要结局

Rate of surgical site infection

时间窗: 30 days

rate of surgical site infection will be measured in percentage

次要结局

未报告次要终点

研究者

发起方
Muhammad Adeel Ashiq
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Muhammad Adeel Ashiq

Dr Muhammad Adeel Ashiq

Children Hospital and Institute of Child Health, Lahore

研究点 (1)

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