The Role of Inflammatory Biomarkers in Preventing Deep St... | NCT07376070

Studies
The Role of Inflammatory Biomarkers in Preventing Deep Sternal Wound Infections After Sternotomy

NCT07376070

Sponsor

Levan Nebieridze

Status

Active, not recruiting

Last Update Posted

Jan 29, 2026Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Deep Sternal Infection
Diabete Mellitus
Mediastinitis

Interventions

Not provided

Countries

Georgia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 14, 2025Actual

Primary Completion Date

Sep 4, 2026Estimated

Completion Date

Apr 14, 2028Estimated

First Submitted Date

Jan 21, 2026

First Submission Date that Met QC Criteria

Jan 21, 2026

First Posted Date

Jan 29, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 21, 2026

Last Update Posted Date

Jan 29, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in pre and postoperative inflammatory biomarker levels associated with development of deep sternal wound infection within 1 month		within 30 days after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

deep sternal wound infection

Exclusion Criteria:

bilateral internal thoracic artery graft

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients from Georgia, who undergo cardiac surgery operation

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tbilisi State Medical University		Tbilisi		0119	Georgia
Bokhua memorial cardiovascular center

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D008480	Mediastinitis

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided