Pediatric Post-operative Abdominal Wound Dehiscence in Association With Midline vs Other Incisions: A Prospective Cohort Study

Pediatric Post-operative Abdominal Wound Dehiscence in Association With Midline vs Other Incisions in Tertiary Care Setting Kabul Afghanistan: A Cohort Study

This study is designed to see different abdominal incisions complication among neonates, infants and children and to find risk factors for developing wound dehiscence

Study Overview

• Status: Completed
• Conditions: Wound Dehiscence; Incision
• Intervention / Treatment: Procedure: laparatomy

• Study Type: Observational
• Enrollment (Actual): 270

Contacts and Locations

Study Locations

• Afghanistan
  • Kabul, Afghanistan, 1006
    • French Medical Institute for Mothers and Children

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

all patients from neonatal age until 18 years old who were planned to undergo abdominal surgery.

Description

Inclusion Criteria:

-all abdominal surgeries patient under 18-year-old.

Exclusion Criteria:

• Umbilical hernia, redo laparatomy, laparoscopic surgery.

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Age Group; Neonates Infants Children	Procedure: laparatomy; all abdominal procedures which are approached by different incisions
Gender; Male Female	Procedure: laparatomy; all abdominal procedures which are approached by different incisions
Selective/Emergency; Selective Emergency	Procedure: laparatomy; all abdominal procedures which are approached by different incisions
Wound Class; Clean Clean-contaminated Contaminated Infected	Procedure: laparatomy; all abdominal procedures which are approached by different incisions
Risk Factors; Yes No	Procedure: laparatomy; all abdominal procedures which are approached by different incisions
Type of Incisions; Midline Trransverse Oblique	Procedure: laparatomy; all abdominal procedures which are approached by different incisions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound dehiscence or burst abdomen	the overall outcome of the intervention (incisions) is wound dehiscence in different age groups, in gender, among who has or has no risk factors and among different wound class	one month after intervention

Collaborators and Investigators

• Sponsor: French Medical Institute for Mothers and Children

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: July 19, 2023
• First Submitted That Met QC Criteria: July 19, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: abdominal wound dehiscence, burst abdomen, pediatric abdominal incisions, children
• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: 40-FMIC-ER-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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