NCT05963477

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
270

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

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

November 1, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

1.7 years

First QC Date

July 19, 2023

Last Update Submit

July 19, 2023

Conditions

Wound DehiscenceIncision

Keywords

abdominal wound dehiscence, burst abdomen, pediatric abdominal incisions, children

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (6)

Age Group

Neonates Infants Children

Procedure: laparatomy

Gender

Male Female

Procedure: laparatomy

Selective/Emergency

Selective Emergency

Procedure: laparatomy

Wound Class

Clean Clean-contaminated Contaminated Infected

Procedure: laparatomy

Risk Factors

Yes No

Procedure: laparatomy

Type of Incisions

Midline Trransverse Oblique

Procedure: laparatomy

Interventions

laparatomyPROCEDURE

all abdominal procedures which are approached by different incisions

Age GroupGenderRisk FactorsSelective/EmergencyType of IncisionsWound Class

Eligibility Criteria

Age1 Day - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Umbilical hernia, redo laparatomy, laparoscopic surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

French Medical Institute for Mothers and Children

Kabul, 1006, Afghanistan

Location

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Abdullah Bahloli

Study Record Dates

First Submitted

July 19, 2023

First Posted

July 27, 2023

Study Start

November 1, 2018

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

July 27, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

AF(1)