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OpenTrials
Completed

NCT Number: NCT07531576

Outcome of Primary vs Delayed Primary Closure of Laparotomy in Dirty Abdominal Wounds

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

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Key information

Age range

15 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ayub Teaching Hospitql

Abbottabad, KPK, 22010, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

.

Treatment and study plan

Delayed Primary Laparotomy wound Closure

Procedure

This technique involves leaving the skin and subcutaneous tissues open for several days following the initial surgery

primary abdominal closure

Procedure

In this intervention, the skin and subcutaneous tissues are closed immediately following the completion of the emergency laparotomy

Primary outcomes

  1. 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

    ,

Sponsors and collaborators

Lead sponsor

Ayub Teaching Hospital

Other

Registry information

Official study title

Outcome of Primary vs Delayed Primary Closure of Laparotomy in Dirty Abdominal Wounds: A Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 15, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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