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临床试验/NCT06732024
NCT06732024尚未招募不适用

Using Vaccum Assisted Closure of Wound Instead of Primary Closure As Prophylactic Way Against Burst Abdomen

Assiut University0 个研究点目标入组 100 人开始时间: 2025年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
Incidence of postoperative burst abdomen in both group

研究概览

简要总结

A vacuum-assisted closure (VAC) device also known as negative pressure wound therapy (NPWT), is a medical treatment used to promote wound healing, it involves using a specialized device to apply negative pressure (suction) to a wound, which helps to accelerate the healing process.

Benefits :

Improved Healing: By removing excess fluid and reducing edema, the VAC device promotes faster wound healing and tissue repair.

Reduced Risk of Infection: The negative pressure helps to reduce bacterial load and create a more favorable environment for healing.

Enhanced Perfusion: The suction can improve blood flow to the wound area, aiding in the delivery of nutrients and oxygen essential for healing.

Granulation Tissue Formation: The therapy encourages the growth of new tissue (granulation tissue) which fills the wound and supports closure.

Overall, VAC therapy is a valuable tool in modern wound care, particularly for complex or difficult-to-heal wounds. If you or someone you know is considering or using this therapy, it's important to follow the guidance of healthcare professionals to maximize its effectiveness and manage any potential risks.

the study aim to evaluate patients , identify high risk ones , preparing to close wound of laparotomy with vaccum assisted device instead of primary closure with suturing till patient's general condition improve then delayed primary closure and comparing that to high risk patients who close wound primarily with suturing in terms of rate of burst abdomen ...this is a randomized controlled trial

详细描述

Burst abdomen (abdominal wound dehiscence) is a severe post-operative complication. Incidence as described in literature ranges from 0.4% to 3.5% ... Burst abdomen is defined as post-operative separation of abdominal Musculo-aponeurotic layers, which is recognized within days after surgery and requires some form of intervention. Various risk factors are responsible for wound dehiscence such as emergency surgery, intra-abdominal infection, malnutrition (hypoalbuminemia, anemia), advanced age, systemic diseases (uremia, diabetes mellitus) etc.... Good knowledge of these risk factors is mandatory for prophylaxis... Patient identified as being high risk may benefit from close observation and early intervention

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • intraabdominal sepsis (wbc:>12000,HR>90,T>38,tachypnea and proven infection) Malnutrition including anaemia and hypoproteinemia Chronic diseases including diabetes and uremia Increased intra abdominal pressure including persistent coughing ,diffuse gaseous distention Smoking Previous abdominal surgery Old age Steroid use
  • operation : Emergency not elective ones Dirty or contaminated Those involving colostomy and ileostomy that is close to wound

排除标准

  • Patients having elective surgery Absence of intra abdominal sepsis Negative exploration

结局指标

主要结局

Incidence of postoperative burst abdomen in both group

时间窗: 1 month

number of patients who will have burst abdomen after surgery

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

Mahmoud Hassan Anwar Ali

resident doctor at general surgery department Faculty of Medicine, Assiut University

Assiut University

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