NCT04258878

Brief Summary

We aim to prospectively evaluate the risk factors that can play a role before, during or after the surgical period.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Typical duration for all trials

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

September 5, 2018

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2021

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

February 6, 2020

Status Verified

February 1, 2020

Enrollment Period

12 months

First QC Date

September 5, 2018

Last Update Submit

February 5, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • surgical wound infection

    Evaluate the duration of complete healing of the sternum :By 1. Radiological (chest x-ray ant-post view and lat view in first 3 weeks post-operative 2. Clinical examination in first 3 weeks post operative

    baseline

Secondary Outcomes (1)

  • Evaluation of perioperative risk factors for surgical wound infection in cardiac surgery

    baseline

Interventions

SternotomyPROCEDURE

Procedure: Sternotomy for coronary artery bypass graft, valvuloplasty, aortic surgery or combined procedures, under extracorporeal circulation or not, in emergency or scheduled.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients who presented to Cardiothoracic Surgery Department, Assiut University Heart Hospital who will undergo coronary artery bypass surgery.

You may qualify if:

  • patient aged more than 18 yards old
  • sternotomy for: coronary artery bypass,

You may not qualify if:

  • patient under age or 18years old.
  • patient who has endocarditis.
  • patient who underwent surgery with prothetic material, within the 12 months preceeding cardiac procedure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Sternotomy

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thoracic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Mahmoud Khairy El-Haish, Prof

    Assuit University Hospital

    STUDY DIRECTOR

Central Study Contacts

Mohammed Hussein Rushdi, Dr

CONTACT

Ahmed Mohammed Taha, Dr

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

September 5, 2018

First Posted

February 6, 2020

Study Start

April 1, 2020

Primary Completion

March 29, 2021

Study Completion

April 30, 2022

Last Updated

February 6, 2020

Record last verified: 2020-02