Clinical trial NCT06732024: Using Vaccum Assisted Closure of Wound Instead of Primary Closure As Prophylactic Way Against Burst Abdomen
Official title: Using Vaccum Assisted Closure of Wound Instead of Primary Closure As Prophylactic Way Against Burst Abdomen
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Burst Abdomen
Keywords: Vaccum Assisted Closure
primary closure
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-12-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Incidence of postoperative burst abdomen in both group
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.