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临床试验/NCT07154277
NCT07154277进行中(未招募)2 期

Abdominal Midline Incisional Closure With Small Bites Vs Large Bites in Emergency Settings

Dow University of Health Sciences2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年11月23日最近更新:

试验速览

阶段
2 期
状态
进行中(未招募)
入组人数
200
试验地点
2
主要终点
Number of participants with Surgical Site Infections

研究概览

简要总结

The goal of this trial is to compare the effectiveness of small bite versus large bite abdominal incision closure in emergency settings. It will also evaluate the safety and outcomes of each technique. The main questions it aims to answer are:

Does small bite closure reduce the incidence of superficial surgical site infections (SSI), wound dehiscence, and incisional hernia compared to large bite closure? What are the associated complications of each closure technique?

Participants will:

Undergo either a small bite or large bite abdominal incision closure during emergency laparotomy Visit the clinic for follow-up assessments at 7 days, 15 days, 1 month, 3 months, and 6 months post-operatively Have their wound healing and complications documented and analyzed during respective visits.

详细描述

Background Wound site complications continue to be a major detrimental factor in surgical healthcare around the globe and are a major concern for general surgeons due to the associated morbidity and mortality. Superficial Surgical Site Infection (SSI) is defined as an infection related to a surgical procedure that occurs near the surgical site within 30 days following surgery (or up to 90 days following surgery where an implant is involved). The incidence of such complications is generally higher in emergency laparotomies compared to elective cases. Surgical technique plays a key role in the integrity of the post-operative wound, and among the numerous factors that influence wound healing, it is the only one under the direct control of the surgeon. The midline incision is the most commonly used surgical incision for emergency laparotomy as it provides quick, wide exposure and avoids damage to nerves, muscles, and the blood supply of the abdominal wall. Closure of the midline wound has traditionally been performed using a mass fashion or large bite technique with a running suture, but recently a new technique of small bite closure has been proposed.

Hypothesis The hypothesis is that small bite closure will have better outcomes than large bite closure in terms of reducing acute wound failure.

Objective This study aims to compare the effectiveness of small bite abdominal incision closure with large bite closure in patients undergoing emergency laparotomy at a tertiary hospital in Karachi, Pakistan.

Materials and Methods

A single-blinded randomized comparative trial will be conducted at Civil Hospital, a tertiary hospital in Karachi, Pakistan. A total of 200 participants will be recruited for this study, with equal participants divided into two groups. Patients undergoing emergency laparotomies will be randomly assigned to one of two groups:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Care Provider, Outcomes Assessor)

盲法说明

Masking is done only for outcome assessor as it is not possible for others to be masked.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults ages in between 18-60 year old
  • All emergency laparotomies (Except trauma)

排除标准

  • Previous surgery with midline incision
  • Pregnancy
  • Current immunosuppressive or chemotherapy
  • Previous incisional hernia after midline incision

结局指标

主要结局

Number of participants with Surgical Site Infections

时间窗: 1 month

As per CDC guidelines and seen by the surgeon

Number of participants with Wound Dehiscence

时间窗: 1 month

Wound dehiscence as seen by the surgeon.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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