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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Burst Abdomen
• Intervention / Treatment: Procedure: Vaccum assisted closure; Procedure: primary wound closure

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: mahmoud hassan Anwer, resident doctor; Phone Number: +201023796252; Email: ohioclassegx98@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group A; Vaccum Assisted Closure of Wound	Procedure: Vaccum assisted closure; close skin and SC tissue by vaccum device
Experimental: group B; primary closure Closure of Wound	Procedure: primary wound closure; close skin and SC tissue by primary closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative burst abdomen in both group	number of patients who will have burst abdomen after surgery	1 month

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Waqar SH, Malik ZI, Razzaq A, Abdullah MT, Shaima A, Zahid MA. Frequency and risk factors for wound dehiscence/burst abdomen in midline laparotomies. J Ayub Med Coll Abbottabad. 2005 Oct-Dec;17(4):70-3.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: December 10, 2024
• First Submitted That Met QC Criteria: December 10, 2024
• First Posted (Estimated): December 13, 2024

Study Record Updates

• Last Update Posted (Estimated): December 13, 2024
• Last Update Submitted That Met QC Criteria: December 10, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: primary closure; Vaccum Assisted Closure
• Other Study ID Numbers: Vaccum/primary closure burst

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No