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

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)

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 Overview

• Status: Completed
• Conditions: Peritonitis; Primary Closure; Delayed Primary Closure
• Intervention / Treatment: Procedure: Delayed Primary Laparotomy wound Closure; Procedure: Primary Abdominal Closure

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • KPK
    • Abbottabad, KPK, Pakistan, 22010
      • Ayub Teaching Hospitql

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Delayed Primary Laparotomy wound Closure	Procedure: Delayed Primary Laparotomy wound Closure; This technique involves leaving the skin and subcutaneous tissues open for several days following the initial surgery; Procedure: Primary Abdominal Closure; In this intervention, the skin and subcutaneous tissues are closed immediately following the completion of the emergency laparotomy
Active Comparator: Primary Abdominal Closure	Procedure: Delayed Primary Laparotomy wound Closure; This technique involves leaving the skin and subcutaneous tissues open for several days following the initial surgery; Procedure: Primary Abdominal Closure; In this intervention, the skin and subcutaneous tissues are closed immediately following the completion of the emergency laparotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Burst Abdomen	This measure tracks the incidence of abdominal wall separation or wound dehiscence following emergency laparotomy ,	14 days follow up period

Collaborators and Investigators

• Sponsor: Ayub Teaching Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2021
• Primary Completion (Actual): June 21, 2021
• Study Completion (Actual): June 21, 2021

Study Registration Dates

• First Submitted: April 9, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 15, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Surgical Site Infection; Emergency Laparotomy; Visceral Perforation; Contaminated Abdominal Wounds; Dirty abdominal wound; Burst abdomen
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Infections; Digestive System Diseases; Peritoneal Diseases; Wound Infection; Intraabdominal Infections; Pathological Conditions, Signs and Symptoms; Surgical Wound Infection; Peritonitis
• Other Study ID Numbers: 161375867867152

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No