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临床试验/NCT07531576
NCT07531576已完成不适用

Outcome of Primary vs Delayed Primary Closure of Laparotomy in Dirty Abdominal Wounds: A Randomized Controlled Trial

Ayub Teaching Hospital1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2021年2月17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
入组人数
78
试验地点
1
主要终点
Frequency of Burst Abdomen

研究概览

简要总结

This randomized controlled trial is designed to evaluate and compare two different wound management strategies-primary closure (PC) and delayed primary closure (DPC)-in patients undergoing emergency laparotomy for peritonitis

  • The primary objective is to determine which technique more effectively reduces postoperative complications, specifically surgical site infections (SSI) and wound dehiscence (burst abdomen), while also assessing the impact on the length of hospital stay (LOS)

The study includes 78 patients aged 15 to 80 years with free intraperitoneal contamination

  • In the PC group, the abdominal wound is closed immediately following the procedure
  • In the DPC group, the skin and subcutaneous tissues are initially left open to allow for drainage and are washed twice weekly until the wound is free of contamination (pus, fecal matter, bile, or blood), at which point it is closed using tension sutures
  • This study aims to provide clinical evidence on whether the biological benefits of DPC-such as reduced bacterial colonization and improved drainage-outweigh the potential drawbacks of the technique, such as patient discomfort or prolonged care

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
15 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • To be included in the study, patients had to meet all of the following requirements:
  • Free intraperitoneal contamination resulting from the perforation of any hollow viscus, abdominal trauma, or firearm injuries
  • . Both genders were eligible for participation
  • . Participants had to fall within the age group of 15 to 80 years

排除标准

  • Patients meeting any of the following conditions were excluded from the trial to ensure the integrity of the results and control for confounding variables:
  • Age: Anyone younger than 15 years of age
  • . Pregnancy: All pregnant women were excluded
  • . Type of Surgery: Patients undergoing elective (scheduled) laparotomy rather than emergency procedures
  • . Medication: Any patient currently using steroids for any medical issue
  • Specific Medical Conditions:
  • Peritonitis caused specifically by pancreatitis . Diabetes mellitus, which was excluded to regulate factors that interfere with wound healing . Individuals with compromised immune systems
  • . These criteria were established to limit the progression of infection and specifically evaluate the impact of the wound closure technique-primary closure versus delayed primary closure-without the interference of significant comorbidities or external factors like malnutrition and immune suppression

研究组 & 干预措施

Delayed Primary Laparotomy wound Closure

Experimental

干预措施: Primary Abdominal Closure (Procedure)

Delayed Primary Laparotomy wound Closure

Experimental

干预措施: Delayed Primary Laparotomy wound Closure (Procedure)

Primary Abdominal Closure

Active Comparator

干预措施: Delayed Primary Laparotomy wound Closure (Procedure)

Primary Abdominal Closure

Active Comparator

干预措施: Primary Abdominal Closure (Procedure)

结局指标

主要结局

Frequency of Burst Abdomen

时间窗: 14 days follow up period

This measure tracks the incidence of abdominal wall separation or wound dehiscence following emergency laparotomy ,

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

MZHaroon

Dr.

Ayub Teaching Hospital

研究点 (1)

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