Surgical Wound InfectionNCT04258878
Prospective Cohort Study in Evaluation of Risk Factors for Infection During and After Coronary Graft Operations.
An observational study of Surgical Wound Infection, run by Assiut University.
Trial summary
We aim to prospectively evaluate the risk factors that can play a role before, during or after the surgical period. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Surgical Wound Infection
- What is being tested?
- Sternotomy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2020to 30 Apr 2022
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
Study population: All patients who presented to Cardiothoracic Surgery Department, Assiut University Heart Hospital who will undergo coronary artery bypass surgery.
Who may be able to join
None listed.
Who cannot join
- patient under age or 18years old.
- patient who has endocarditis.
- patient who underwent surgery with prothetic material, within the 12 months preceeding cardiac procedure.
Trial locations and contacts
No sites are listed yet.
About this study
We aim to prospectively evaluate the risk factors that can play a role before, during or after the surgical period.
Read the detailed description
Surgical site infections (SSIs) are either superficial or deep and may involve the organs, or spaces accessed during an operation. The reported incidence of SSIs in coronary artery bypass grafting (CABG) surgery ranges between 0.3% and 8%.
There is a strong suggestion that an impairment of vascular supply of the sternum may be one of the most important factors influencing the incidence of deep sternal wound infection (DSWI). Several studies have studied the risk factors for SSIs including DSWI in cardiac surgery. These risk factors included obesity, diabetes mellitus, chronic obstructive pulmonary disease (COPD), connective tissue disease, steroid use, smoking, peripheral vascular disease and renal insufficiency. In addition, intraoperative factors (e.g., use of bilateral internal mammary arteries [BIMA] grafting, prolonged cardiopulmonary bypass [CPB] duration) and postoperative variables (e.g., prolonged mechanical ventilation, reoperation for bleeding, postoperative transfusions and gastrointestinal, nephrological and respiratory complications) have been shown to be associated with DSWI.
The risk for sternal wound infection (SWI) is increased if cardiac surgery involves internal thoracic arteries grafting and a valve procedure, or use of a ventricular assist device.
Leg wound infections at donor sites account for >70% of cases with severe infection following cardiac surgery.
Cardiac SSIs increase the length of hospital stay (LOS) and increase treatment costs in proportion to the severity of the infection. These costs increase by 3.8%, 14.7% and 29.4% in mild, moderate and severe infections respectively.
Treatment is often confounded by the emergence of antibiotic-resistant pathogens and in addition, substantial proportions of these infected patients are elderly and have co-existing medical problems. In the past, such elderly patients with significant comorbidities would not have been considered for surgery.[8] As the population ages, it is reasonable to assume that older and sicker patients will be admitted for surgery, and this will inevitably increase the risk and incidence of SSIs.
- Conditions
- Surgical Wound Infection
- Being tested
- Sternotomy
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SternotomyProcedure or surgery
Procedure: Sternotomy for coronary artery bypass graft, valvuloplasty, aortic surgery or combined procedures, under extracorporeal circulation or not, in emergency or scheduled.
What is being measured
The primary outcome is the main question the study is designed to answer.
surgical wound infection
Evaluate the duration of complete healing of the sternum :By
- Radiological (chest x-ray ant-post view and lat view in first 3 weeks post-operative
- Clinical examination in first 3 weeks post operative
Measured: baseline
Secondary outcomes (1)
Evaluation of perioperative risk factors for surgical wound infection in cardiac surgery
- Evaluate rate of wound infection in first 3 weeks post operative
- -Evaluate the improvement in symptoms of patients postoperative: By
- pain by pain score in first 3 week post operative
- regain normal activity in first 3 week post operative
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start1 Apr 2020 (estimated)
- Primary completion29 Mar 2021 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Wound InfectionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Hussein Rushdi, Assiut University
- Investigators
- Mahmoud Khairy El-Haish, Prof, Study director, Assuit University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04258878
- Sponsor's protocol ID
- periop- RFs in cardiac surgery
- Status last verified
- Feb 2020
- First submitted
- 5 Sep 2018
- Last updated
- 6 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study in Evaluation of Risk Factors for Infection During and After Coronary Graft Operations.
- ClinicalTrials.gov ID
- NCT04258878
- Acronym / sponsor ID
- periop- RFs in cardiac surgery
- Conditions
- Surgical Wound Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 29 Mar 2021 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 6 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We aim to prospectively evaluate the risk factors that can play a role before, during or after the surgical period.
Detailed description
Surgical site infections (SSIs) are either superficial or deep and may involve the organs, or spaces accessed during an operation. The reported incidence of SSIs in coronary artery bypass grafting (CABG) surgery ranges between 0.3% and 8%.
There is a strong suggestion that an impairment of vascular supply of the sternum may be one of the most important factors influencing the incidence of deep sternal wound infection (DSWI). Several studies have studied the risk factors for SSIs including DSWI in cardiac surgery. These risk factors included obesity, diabetes mellitus, chronic obstructive pulmonary disease (COPD), connective tissue disease, steroid use, smoking, peripheral vascular disease and renal insufficiency. In addition, intraoperative factors (e.g., use of bilateral internal mammary arteries [BIMA] grafting, prolonged cardiopulmonary bypass [CPB] duration) and postoperative variables (e.g., prolonged mechanical ventilation, reoperation for bleeding, postoperative transfusions and gastrointestinal, nephrological and respiratory complications) have been shown to be associated with DSWI.
The risk for sternal wound infection (SWI) is increased if cardiac surgery involves internal thoracic arteries grafting and a valve procedure, or use of a ventricular assist device.
Leg wound infections at donor sites account for >70% of cases with severe infection following cardiac surgery.
Cardiac SSIs increase the length of hospital stay (LOS) and increase treatment costs in proportion to the severity of the infection. These costs increase by 3.8%, 14.7% and 29.4% in mild, moderate and severe infections respectively.
Treatment is often confounded by the emergence of antibiotic-resistant pathogens and in addition, substantial proportions of these infected patients are elderly and have co-existing medical problems. In the past, such elderly patients with significant comorbidities would not have been considered for surgery.[8] As the population ages, it is reasonable to assume that older and sicker patients will be admitted for surgery, and this will inevitably increase the risk and incidence of SSIs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients who presented to Cardiothoracic Surgery Department, Assiut University Heart Hospital who will undergo coronary artery bypass surgery.
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- patient under age or 18years old.
- patient who has endocarditis.
- patient who underwent surgery with prothetic material, within the 12 months preceeding cardiac procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SternotomyProcedure: Sternotomy for coronary artery bypass graft, valvuloplasty, aortic surgery or combined procedures, under extracorporeal circulation or not, in emergency or scheduled. | Procedure or surgery | – |
Primary outcome
surgical wound infection
Time frame: baseline
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
1 secondary outcome
Evaluation of perioperative risk factors for surgical wound infection in cardiac surgery
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud Khairy El-Haish, Prof study director
Assuit University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Wound Infection, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Hussein Rushdi, Dr (201124239591, mhrd2017@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
surgical wound infection (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2020.