NCT07142395

Brief Summary

The purpose of this study is to find out which type of wound closure after emergency abdominal surgery leads to fewer wound infections and better recovery: closing the wound immediately after surgery (called primary closure) or waiting a few days before closing the skin (called delayed primary closure). Wound infection is a common problem after emergency abdominal surgery (also called laparotomy). Some surgeons close the skin right away, while others wait a few days to reduce the risk of infection. This study will help find out which method is better. The main questions the study aims to answer are:

  • Adult patients needing emergency abdominal surgery will be included.
  • Half the patients will have their wounds closed immediately (primary closure), and half will have delayed closure after 3-5 days of daily dressing.
  • All surgeries will be done by experienced surgeons using the same technique.
  • Patients will be followed for 4 weeks after surgery to monitor wound infection, wound opening, and length of hospital stay. The results will help doctors choose the safest and most effective way to close surgical wounds after emergency abdominal surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 16, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2025

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 26, 2025

Completed
Last Updated

September 5, 2025

Status Verified

September 1, 2025

Enrollment Period

3 months

First QC Date

August 6, 2025

Last Update Submit

September 3, 2025

Conditions

Keywords

wound infectionprimary wound closuredelayed wound closureWound dehiscence

Outcome Measures

Primary Outcomes (1)

  • Wound Infection

    Surgical Site infection - Presence any features of erythema, pain, pus discharge on examination of surgical wound and new onset fever (\> 98.6 F)

    From date of surgery to Four weeks postoperatively

Other Outcomes (2)

  • Hospital Stay

    From date of surgery until date of hospital discharge, up to 28 days

  • Wound dehiscence

    From date of laparotomy to Four weeks post-operatively

Study Arms (2)

Primary Closure

ACTIVE COMPARATOR

Skin closed immediately after laparotomy

Procedure: Immediate skin closure

Delayed Primary Closure

EXPERIMENTAL

Skin closed 3 - 5 days after laparotomy

Procedure: Delayed primary closure

Interventions

After laparotomy wounds will be closed primarily using no. 1 vicryl suture

Primary Closure

Deeper layers of wound will be closed after surgery and loose mattress sutures will be applied to skin with prolene. After three to five days of daily dressing with bactericidal solution, the skin will be closed

Delayed Primary Closure

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients 18 - 60 years of age
  • Either male or female gender and
  • Planned to undergo emergency laparotomy

You may not qualify if:

  • Patients undergoing second laparotomy
  • Re- laparotomy
  • On steroid therapy and
  • Patients who die within 28-days of surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bakhtawar Amin Medical and Dental College

Multan, Punjab Province, 60000, Pakistan

Location

MeSH Terms

Conditions

Wound Infection

Condition Hierarchy (Ancestors)

Infections

Study Officials

  • Amjad A Professor, FRCS

    Bakhtawar Amin Medical and Dental College

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2025

First Posted

August 26, 2025

Study Start

May 16, 2025

Primary Completion

August 15, 2025

Study Completion

August 15, 2025

Last Updated

September 5, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations