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

NCT ID: NCT06732024

Last Updated: 2024-12-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2026-03-01

Brief Summary

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

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

Conditions

Burst Abdomen

Keywords

Vaccum Assisted Closure; primary closure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

group A

Vaccum Assisted Closure of Wound

Group Type: EXPERIMENTAL

Vaccum assisted closure

Intervention Type: PROCEDURE

close skin and SC tissue by vaccum device

group B

primary closure Closure of Wound

Group Type: EXPERIMENTAL

primary wound closure

Intervention Type: PROCEDURE

close skin and SC tissue by primary closure

Interventions

Vaccum assisted closure

close skin and SC tissue by vaccum device

Intervention Type: PROCEDURE

primary wound closure

close skin and SC tissue by primary closure

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Hassan Anwar Ali

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

mahmoud hassan Anwer, resident doctor

Role: CONTACT

Phone: +201023796252

Email: ohioclassegx98@gmail.com

References

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.

Reference Type: BACKGROUND

PMID: 16599042 (View on PubMed)

Other Identifiers

Vaccum/primary closure burst

Identifier Type: -

Identifier Source: org_study_id