Coronary Artery Bypass GraftingNCT07043296
Risk Factors for Deep Sternal Wound Infection After Coronary Artery Bypass Grafting
An observational study of Coronary Artery Bypass Grafting, run by Assiut University.
Trial summary
Deep sternal wound infection (DSWI) constitutes a serious complication after coronary artery bypass grafting (CABG) surgery with potentially devastating consequences for patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass Grafting
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 1 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients for CABG operation
Who may be able to join
- All patients for CABG operation
Who cannot join
- patients who died during operations or shortly after it.
About this study
Deep sternal wound infection (DSWI) constitutes a serious complication after coronary artery bypass grafting (CABG) surgery with potentially devastating consequences for patients. (1) Although median sternotomy is known to offer an excellent approach in CBAG, the impact of DSWI on patient prognosis remains significant. (2) The advances made in the field of prevention allowed the incidence of DSWI to decrease drastically in CBAG operations. (3,4) DSWI has been shown to lead to life- threatening complications linked with an increase in long and short-term mortality, morbidity, cost of care, prolonged hospital stays and in-hospital mortality. (5-8) There are a reported numerous risk factors potentially contributing to the development of DSWI in CABG, including the use of the internal thoracic artery for revascularization, long operative time, reoperation, an excessive use of bone wax and electrocoagulation, peripheral mechanical ventilation and other patient- related immunosuppressive risk factors. (9,10) Metabolic disorders such as diabetes, hypertension, dyslipidaemia and obesity leading to increased risk of poor clinical outcomes. (11) The aim of this study is determine the cut off point for some of known risk factors for deep sternal wound infection after Coronary artery bypass grafting.
- Conditions
- Coronary Artery Bypass Grafting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| study group | patients for CABG operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative infection
postoperative wound infection after CABG
Measured: 30 DAy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass GraftingStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Alaa Eldien Ali Hassan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043296
- Sponsor's protocol ID
- DSWI risk factors
- Status last verified
- Jun 2025
- First submitted
- 20 Jun 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Deep Sternal Wound Infection After Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT07043296
- Acronym / sponsor ID
- DSWI risk factors
- Conditions
- Coronary Artery Bypass Grafting
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 29 Jun 2025 (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.
Deep sternal wound infection (DSWI) constitutes a serious complication after coronary artery bypass grafting (CABG) surgery with potentially devastating consequences for patients. (1) Although median sternotomy is known to offer an excellent approach in CBAG, the impact of DSWI on patient prognosis remains significant. (2) The advances made in the field of prevention allowed the incidence of DSWI to decrease drastically in CBAG operations. (3,4) DSWI has been shown to lead to life- threatening complications linked with an increase in long and short-term mortality, morbidity, cost of care, prolonged hospital stays and in-hospital mortality. (5-8) There are a reported numerous risk factors potentially contributing to the development of DSWI in CABG, including the use of the internal thoracic artery for revascularization, long operative time, reoperation, an excessive use of bone wax and electrocoagulation, peripheral mechanical ventilation and other patient- related immunosuppressive risk factors. (9,10) Metabolic disorders such as diabetes, hypertension, dyslipidaemia and obesity leading to increased risk of poor clinical outcomes. (11) The aim of this study is determine the cut off point for some of known risk factors for deep sternal wound infection after Coronary artery bypass grafting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | –patients for CABG operation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients for CABG operation
Key inclusion criteria (1 listed)
- All patients for CABG operation
Key exclusion criteria (1 listed)
- patients who died during operations or shortly after it.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
postoperative infection
Time frame: 30 DAy
postoperative wound infection after CABG
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
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Coronary Artery Bypass Graft (CABG)
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Bypass Grafting, 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 29 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative infection (time frame: 30 DAy). 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 29 Jun 2025.