NCT07531576

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 17, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2021

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 15, 2026

Completed
Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

April 9, 2026

Last Update Submit

April 9, 2026

Conditions

PeritonitisPrimary ClosureDelayed Primary Closure

Keywords

Visceral PerforationContaminated Abdominal WoundsEmergency LaparotomySurgical Site InfectionDirty abdominal woundBurst abdomen

Outcome Measures

Primary Outcomes (1)

  • Frequency of Burst Abdomen

    This measure tracks the incidence of abdominal wall separation or wound dehiscence following emergency laparotomy ,

    14 days follow up period

Study Arms (2)

Delayed Primary Laparotomy wound Closure

EXPERIMENTAL
Procedure: Delayed Primary Laparotomy wound ClosureProcedure: Primary Abdominal Closure

Primary Abdominal Closure

ACTIVE COMPARATOR
Procedure: Delayed Primary Laparotomy wound ClosureProcedure: Primary Abdominal Closure

Interventions

Delayed Primary Laparotomy wound ClosurePROCEDURE

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

Delayed Primary Laparotomy wound ClosurePrimary Abdominal Closure
Primary Abdominal ClosurePROCEDURE

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

Delayed Primary Laparotomy wound ClosurePrimary Abdominal Closure

Eligibility Criteria

Age15 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ayub Teaching Hospitql

Abbottabad, KPK, 22010, Pakistan

Location

MeSH Terms

Conditions

PeritonitisSurgical Wound Infection

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsPeritoneal DiseasesDigestive System DiseasesWound InfectionPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

April 9, 2026

First Posted

April 15, 2026

Study Start

February 17, 2021

Primary Completion

June 21, 2021

Study Completion

June 21, 2021

Last Updated

April 15, 2026

Record last verified: 2026-04

Locations

PA(1)