NCT05715060

Brief Summary

comparison between stainless steel wires and PDS in closure of sternum in children after cardiac surgery in terms of sternal dehiscence, infection \& cosmetic outcome

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 8, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 6, 2023

Completed
23 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

February 6, 2023

Status Verified

February 1, 2023

Enrollment Period

1.3 years

First QC Date

November 8, 2022

Last Update Submit

February 4, 2023

Conditions

Open Heart Surgery

Outcome Measures

Primary Outcomes (1)

  • Sternal stability

    Comparison of incidence of sternal dehiscence \& instability between 2 groups this is done by clinical assessment(history \& examination) \& follow up chest x-rays

    up to 2 years

Secondary Outcomes (2)

  • cosmetic outcome (prominent wire)

    up to 2 years

  • Wound infection

    up to 2 years

Study Arms (2)

stainless steel wire closure

ACTIVE COMPARATOR

conventional closure of median sternotomy by stainless steel wire

Procedure: Median sternotomy closure (sternal closure)

PDS sternal closure

ACTIVE COMPARATOR

closure of median sternotomy by PDS

Procedure: Median sternotomy closure (sternal closure)

Interventions

Median sternotomy closure (sternal closure)PROCEDURE

Comparison of Sternal closure after cardiac surgery between conventional way which is by stainless steel wire \& Polydioxanone (PDS)

PDS sternal closurestainless steel wire closure

Eligibility Criteria

AgeUp to 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants \& children up to 5 years old underwent open heart surgery in Assiut University heart hospital

You may not qualify if:

  • Older than 5 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University heart hospital

Asyut, 71511, Egypt

Location

Study Design

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

Study Record Dates

First Submitted

November 8, 2022

First Posted

February 6, 2023

Study Start

March 1, 2023

Primary Completion

June 1, 2024

Study Completion

December 1, 2024

Last Updated

February 6, 2023

Record last verified: 2023-02

Locations

EG(1)