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

NCT06732024 | Not Yet Recruiting DMC

• 1 other identifier: Vaccum/primary closure burst
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Conditions

Burst Abdomen

Keywords

Vaccum Assisted Closure; primary closure

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative burst abdomen in both group

  number of patients who will have burst abdomen after surgery

  1 month

Study Arms (2)

group A

EXPERIMENTAL

Vaccum Assisted Closure of Wound

Procedure: Vaccum assisted closure

group B

EXPERIMENTAL

primary closure Closure of Wound

Procedure: primary wound closure

Interventions

Vaccum assisted closure PROCEDURE

close skin and SC tissue by vaccum device

group A

primary wound closure PROCEDURE

close skin and SC tissue by primary closure

group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• 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.

  PMID: 16599042 BACKGROUND

Central Study Contacts

mahmoud hassan Anwer, resident doctor

CONTACT

+201023796252; ohioclassegx98@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at general surgery department Faculty of Medicine, Assiut University

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 13, 2024
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 13, 2024

Record last verified: 2024-12