PeritonitisNCT07531576
Outcome of Primary vs Delayed Primary Closure of Laparotomy in Dirty Abdominal Wounds
A study testing Delayed Primary Laparotomy wound Closure and Primary Abdominal Closure in people with Peritonitis and Primary Closure, run by Ayub Teaching Hospital at 1 site in Pakistan.
Trial summary
This randomized controlled trial is designed to evaluate and compare two different wound management strategies-primary closure (PC) and delayed primary closure (DPC)-in patients undergoing emergency laparotomy for peritonitis The primary objective is to determine which technique more effectively reduces postoperative… Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Peritonitis, Primary Closure, Delayed Primary Closure
- What is being tested?
- Delayed Primary Laparotomy wound Closure and Primary Abdominal Closure
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Feb 2021to 21 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- To be included in the study, patients had to meet all of the following requirements:
- Free intraperitoneal contamination resulting from the perforation of any hollow viscus, abdominal trauma, or firearm injuries
- . Both genders were eligible for participation
- . Participants had to fall within the age group of 15 to 80 years
- . Exclusion Criteria
- Patients meeting any of the following conditions were excluded from the trial to ensure the integrity of the results and control for confounding variables:
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- Age: Anyone younger than 15 years of age
- . Pregnancy: All pregnant women were excluded
- . Type of Surgery: Patients undergoing elective (scheduled) laparotomy rather than emergency procedures
- . Medication: Any patient currently using steroids for any medical issue
- .
- Specific Medical Conditions:
- Peritonitis caused specifically by pancreatitis . Diabetes mellitus, which was excluded to regulate factors that interfere with wound healing . Individuals with compromised immune systems
- . These criteria were established to limit the progression of infection and specifically evaluate the impact of the wound closure technique-primary closure versus delayed primary closure-without the interference of significant comorbidities or external factors like malnutrition and immune suppression
- .
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcome of Primary vs Delayed Primary Closure of Laparotomy in Dirty Abdominal Wounds: A Randomized Controlled Trial
This randomized controlled trial is designed to evaluate and compare two different wound management strategies-primary closure (PC) and delayed primary closure (DPC)-in patients undergoing emergency laparotomy for peritonitis
- The primary objective is to determine which technique more effectively reduces postoperative complications, specifically surgical site infections (SSI) and wound dehiscence (burst abdomen), while also assessing the impact on the length of hospital stay (LOS)
Read more
The study includes 78 patients aged 15 to 80 years with free intraperitoneal contamination
- In the PC group, the abdominal wound is closed immediately following the procedure
- In the DPC group, the skin and subcutaneous tissues are initially left open to allow for drainage and are washed twice weekly until the wound is free of contamination (pus, fecal matter, bile, or blood), at which point it is closed using tension sutures
- This study aims to provide clinical evidence on whether the biological benefits of DPC-such as reduced bacterial colonization and improved drainage-outweigh the potential drawbacks of the technique, such as patient discomfort or prolonged care
- Conditions
- Peritonitis, Primary Closure, Delayed Primary Closure
- Being tested
- Delayed Primary Laparotomy wound Closure, Primary Abdominal Closure
- Keywords
- Visceral Perforation, Contaminated Abdominal Wounds, Emergency Laparotomy, Surgical Site Infection, Dirty abdominal wound, Burst abdomen
- Medical subject headings
- Peritonitis, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delayed Primary Laparotomy wound ClosureProcedure or surgery
This technique involves leaving the skin and subcutaneous tissues open for several days following the initial surgery
Primary Abdominal ClosureProcedure or surgery
In this intervention, the skin and subcutaneous tissues are closed immediately following the completion of the emergency laparotomy
| Study group | Role | What they receive |
|---|---|---|
| Delayed Primary Laparotomy wound Closure | Experimental | Not described Receives: Procedure: Delayed Primary Laparotomy wound Closure; Procedure: Primary Abdominal Closure |
| Primary Abdominal Closure | Active comparator | Not described Receives: Procedure: Delayed Primary Laparotomy wound Closure; Procedure: Primary Abdominal Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Burst Abdomen
This measure tracks the incidence of abdominal wall separation or wound dehiscence following emergency laparotomy
,
Measured: 14 days follow up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start17 Feb 2021
- Primary completion21 Jun 2021
- Study completion21 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeritonitisStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ayub Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MZHaroon, Ayub Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07531576
- Sponsor's protocol ID
- 161375867867152
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Primary vs Delayed Primary Closure of Laparotomy in Dirty Abdominal Wounds: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07531576
- Acronym / sponsor ID
- 161375867867152
- Conditions
- Peritonitis, Primary Closure, Delayed Primary Closure
- Keywords
- Visceral Perforation, Contaminated Abdominal Wounds, Emergency Laparotomy, Surgical Site Infection, Dirty abdominal wound, Burst abdomen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Ayub Teaching HospitalUniversity, hospital or other
- Study start
- 17 Feb 2021 (actual)
- Primary completion
- 21 Jun 2021 (actual)
- Study completion
- 21 Jun 2021 (actual)
- First posted
- 15 Apr 2026 (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.
This randomized controlled trial is designed to evaluate and compare two different wound management strategies-primary closure (PC) and delayed primary closure (DPC)-in patients undergoing emergency laparotomy for peritonitis
- The primary objective is to determine which technique more effectively reduces postoperative complications, specifically surgical site infections (SSI) and wound dehiscence (burst abdomen), while also assessing the impact on the length of hospital stay (LOS)
The study includes 78 patients aged 15 to 80 years with free intraperitoneal contamination
- In the PC group, the abdominal wound is closed immediately following the procedure
- In the DPC group, the skin and subcutaneous tissues are initially left open to allow for drainage and are washed twice weekly until the wound is free of contamination (pus, fecal matter, bile, or blood), at which point it is closed using tension sutures
- This study aims to provide clinical evidence on whether the biological benefits of DPC-such as reduced bacterial colonization and improved drainage-outweigh the potential drawbacks of the technique, such as patient discomfort or prolonged care
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delayed Primary Laparotomy wound Closure | Experimental | Procedure: Delayed Primary Laparotomy wound Closure, Procedure: Primary Abdominal Closure |
| Primary Abdominal Closure | Active comparator | Procedure: Delayed Primary Laparotomy wound Closure, Procedure: Primary Abdominal Closure |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Free intraperitoneal contamination resulting from the perforation of any hollow viscus, abdominal trauma, or firearm injuries
- . Both genders were eligible for participation
- . Participants had to fall within the age group of 15 to 80 years
- . Exclusion Criteria
- Patients meeting any of the following conditions were excluded from the trial to ensure the integrity of the results and control for confounding variables:
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Delayed Primary Laparotomy wound ClosureThis technique involves leaving the skin and subcutaneous tissues open for several days following the initial surgery | Procedure or surgery | Delayed Primary Laparotomy wound Closure, Primary Abdominal Closure |
| Primary Abdominal ClosureIn this intervention, the skin and subcutaneous tissues are closed immediately following the completion of the emergency laparotomy | Procedure or surgery | Delayed Primary Laparotomy wound Closure, Primary Abdominal Closure |
Primary outcome
Frequency of Burst Abdomen
Time frame: 14 days follow up period
This measure tracks the incidence of abdominal wall separation or wound dehiscence following emergency laparotomy ,
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delayed Primary Laparotomy wound Closure and Primary Abdominal Closure in people with Peritonitis and Primary Closure, run by Ayub Teaching Hospital at 1 site in Pakistan.
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 15 inclusion and 0 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: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Burst Abdomen (time frame: 14 days follow up period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2026.