NCT07376070

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
24mo left

Started Apr 2025

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

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

Study Progress35%
Apr 2025Apr 2028

Study Start

First participant enrolled

April 14, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2026

Expected
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2028

Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

1.4 years

First QC Date

January 21, 2026

Last Update Submit

January 21, 2026

Conditions

Diabete MellitusMediastinitisDeep Sternal Infection

Outcome Measures

Primary Outcomes (1)

  • change in pre and postoperative inflammatory biomarker levels associated with development of deep sternal wound infection within 1 month

    within 30 days after surgery

Eligibility Criteria

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

patients from Georgia, who undergo cardiac surgery operation

You may qualify if:

  • deep sternal wound infection

You may not qualify if:

  • bilateral internal thoracic artery graft

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tbilisi State Medical University

Tbilisi, 0119, Georgia

Location

Bokhua memorial cardiovascular center

Tbilisi, Georgia

Location

MeSH Terms

Conditions

Diabetes MellitusMediastinitis

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesMediastinal DiseasesThoracic DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Junior physician, cardiac surgery

Study Record Dates

First Submitted

January 21, 2026

First Posted

January 29, 2026

Study Start

April 14, 2025

Primary Completion (Estimated)

September 4, 2026

Study Completion (Estimated)

April 14, 2028

Last Updated

January 29, 2026

Record last verified: 2026-01

Locations

GE(2)