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

• Sponsor: French Medical Institute for Mothers and Children (Other)
• Overall Status: Completed
• CT.gov ID: NCT05963477
• Collaborator: (none)
• Enrollment: 270
• Location: 1
• Actual Duration (Months): 19.9
• Patients Per Site Per Month: 13.5

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Wound Dehiscence; Incision	Procedure: laparatomy

Study Design

• Study Type: Observational
• Actual Enrollment: 270 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Pediatric Post-operative Abdominal Wound Dehiscence in Association With Midline vs Other Incisions in Tertiary Care Setting Kabul Afghanistan: A Cohort Study
• Actual Study Start Date: Nov 1, 2018
• Actual Primary Completion Date: Jun 30, 2020
• Actual Study Completion Date: Jun 30, 2020

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Wound dehiscence or burst abdomen [one month after intervention]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Day to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• Umbilical hernia, redo laparatomy, laparoscopic surgery.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	French Medical Institute for Mothers and Children	Kabul		Afghanistan	1006

Sponsors and Collaborators

• French Medical Institute for Mothers and Children

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 17, 2018

More Information

Publications

None provided.

• Responsible Party: Abdullah Bahloli, Dr. Abdullah Bahloli, French Medical Institute for Mothers and Children
• ClinicalTrials.gov Identifier: NCT05963477
• Other Study ID Numbers: 40-FMIC-ER-18
• First Posted: Jul 27, 2023
• Last Update Posted: Jul 27, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Abdullah Bahloli, Dr. Abdullah Bahloli, French Medical Institute for Mothers and Children: abdominal wound dehiscence, burst abdomen, pediatric abdominal incisions, children
• Additional relevant MeSH terms: Wounds and Injuries; Surgical Wound

Study Results

No Results Posted as of Jul 27, 2023