Deep Sternal InfectionNCT07376070
The Role of Inflammatory Biomarkers in Preventing Deep Sternal Wound Infections After Sternotomy
An observational study of Deep Sternal Infection and Diabete Mellitus, run by Levan Nebieridze at 2 sites in Georgia.
Trial summary
The goal of this observational study is to reveal blood biomarkers that will have prognostic significance in terms of the development of deep wound infection following sternotomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Sternal Infection, Diabete Mellitus, Mediastinitis
- How many people
- 30 participants
- Where
- 2 sitesGeorgia
- Study dates
- 14 Apr 2025to 14 Apr 2028
- 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: patients from Georgia, who undergo cardiac surgery operation
Who may be able to join
- deep sternal wound infection
Who cannot join
- bilateral internal thoracic artery graft
Trial locations and contacts
2 sites in 1 country.
Georgia2 sites
Tbilisi State Medical University
Tbilisi, 0119
Bokhua memorial cardiovascular center
Tbilisi
About this study
The goal of this observational study is to reveal blood biomarkers that will have prognostic significance in terms of the development of deep wound infection following sternotomy. As for the practical significance of the study, blood biomarkers correlated with deep wound infections can be used to prevent the development of wound infections in the postoperative period. Based on this, it is possible to formulate an algorithm for preventive measures.
- Conditions
- Deep Sternal Infection, Diabete Mellitus, Mediastinitis
- Medical subject headings
- Diabetes Mellitus, Mediastinitis
What is being measured
The primary outcome is the main question the study is designed to answer.
change in pre and postoperative inflammatory biomarker levels associated with development of deep sternal wound infection within 1 month
Measured: within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start14 Apr 2025
- Primary completion4 Sep 2026 (estimated)
- Study completion14 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Sternal InfectionStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Levan Nebieridze
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Levan Nebieridze, Tbilisi State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07376070
- Sponsor's protocol ID
- TbilisiSMU
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Inflammatory Biomarkers in Preventing Deep Sternal Wound Infections After Sternotomy
- ClinicalTrials.gov ID
- NCT07376070
- Acronym / sponsor ID
- TbilisiSMU
- Conditions
- Deep Sternal Infection, Diabete Mellitus, Mediastinitis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Levan NebieridzeUniversity, hospital or other
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 4 Sep 2026 (estimated)
- Study completion
- 14 Apr 2028 (estimated)
- First posted
- 29 Jan 2026 (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.
The goal of this observational study is to reveal blood biomarkers that will have prognostic significance in terms of the development of deep wound infection following sternotomy. As for the practical significance of the study, blood biomarkers correlated with deep wound infections can be used to prevent the development of wound infections in the postoperative period. Based on this, it is possible to formulate an algorithm for preventive measures.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients from Georgia, who undergo cardiac surgery operation
Key inclusion criteria (1 listed)
- deep sternal wound infection
Key exclusion criteria (1 listed)
- bilateral internal thoracic artery graft
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
change in pre and postoperative inflammatory biomarker levels associated with development of deep sternal wound infection within 1 month
Time frame: within 30 days after surgery
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 Jan 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Sternal Infection and Diabete Mellitus, run by Levan Nebieridze at 2 sites in Georgia.
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: under way, not looking for participants, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
change in pre and postoperative inflammatory biomarker levels associated with development of deep sternal wound infection within 1 month (time frame: within 30 days after surgery). 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 Jan 2026.