Burst AbdomenNCT06732024
Using Vaccum Assisted Closure of Wound Instead of Primary Closure as Prophylactic Way Against Burst Abdomen
A study testing Vaccum assisted closure and primary wound closure in people with Burst Abdomen, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burst Abdomen
- What is being tested?
- Vaccum assisted closure and primary wound closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients having elective surgery Absence of intra abdominal sepsis Negative exploration
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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 :
Read more
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
Read the 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
- Being tested
- Vaccum assisted closure, primary wound closure
- Keywords
- Vaccum Assisted Closure, primary closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccum assisted closureProcedure or surgery
close skin and SC tissue by vaccum device
primary wound closureProcedure or surgery
close skin and SC tissue by primary closure
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | Vaccum Assisted Closure of Wound Receives: Procedure: Vaccum assisted closure |
| group B | Experimental | primary closure Closure of Wound Receives: Procedure: primary wound closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative burst abdomen in both group
number of patients who will have burst abdomen after surgery
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Burst AbdomenStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Hassan Anwar Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06732024
- Sponsor's protocol ID
- Vaccum/primary closure burst
- Status last verified
- Dec 2024
- First submitted
- 10 Dec 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 16599042
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Vaccum Assisted Closure of Wound Instead of Primary Closure as Prophylactic Way Against Burst Abdomen
- ClinicalTrials.gov ID
- NCT06732024
- Acronym / sponsor ID
- Vaccum/primary closure burst
- Conditions
- Burst Abdomen
- Keywords
- Vaccum Assisted Closure, primary closure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Procedure: Vaccum assisted closureVaccum Assisted Closure of Wound |
| group B | Experimental | Procedure: primary wound closureprimary closure Closure of Wound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patients having elective surgery Absence of intra abdominal sepsis Negative exploration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaccum assisted closureclose skin and SC tissue by vaccum device | Procedure or surgery | group A |
| primary wound closureclose skin and SC tissue by primary closure | Procedure or surgery | group B |
Primary outcome
Incidence of postoperative burst abdomen in both group
Time frame: 1 month
number of patients who will have burst abdomen after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Results publication: PubMed 16599042Waqar 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.
- Individual participant dataSharing planned: Undecided
Related trials for Burst Abdomen
Recruiting
A One-year Follow-up of Incisional Hernia Formation Between Device Assisted and Manual Laparotomy Closure
Incisional Hernia After Midline Laparotomy, Colorectal Cancer
Not yet recruiting
Vacuum-Assisted Closure Versus Graduated Primary Skin Closure for Postoperative Burst Abdomen
Abdominal Wound Dehiscence, Burst Abdomen
Recruiting
NoPro - Norwegian Hernia Prophylaxis Study
Incisional Hernia After Midline Laparotomy, Quality of Life (QOL)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Vaccum assisted closure and primary wound closure in people with Burst Abdomen, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact mahmoud hassan Anwer, resident doctor (+201023796252, ohioclassegx98@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative burst abdomen in both group (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06732024, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.