Outcome of Primary vs Delayed Primary Closure of Laparotomy in Dirty Abdominal Wounds (NCT07531576) | Clinical Trial Compass
CompletedNot Applicable
Outcome of Primary vs Delayed Primary Closure of Laparotomy in Dirty Abdominal Wounds
Pakistan78 participantsStarted 2021-02-17
Plain-language 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 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
Who can participate
Age range
15 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
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:
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
.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.