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Clinical Trials/NCT07228598
NCT07228598RecruitingNot Applicable

Biofilm Formation on Thoracic Drains: Clinical Significance and Association With Antibiotic Resistance

Caner İşevi, MD1 site in 1 country180 target enrollmentStarted: October 1, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
180
Locations
1
Primary Endpoint
Presence and Intensity of Biofilm Formation on Chest Drain Tips

Study Overview

Brief Summary

This prospective observational study aims to investigate the frequency and clinical significance of biofilm formation on thoracic chest drains used after thoracic surgery. Biofilms are structured bacterial communities that adhere to surfaces and can promote infection and antibiotic resistance. In this study, small samples from the tips of chest drains will be collected under sterile conditions at the time of drain removal and analyzed in the microbiology laboratory.

The main objectives are to evaluate the relationship between the duration of chest drain placement and the presence of biofilm, and to identify the antibiotic resistance profiles of microorganisms isolated from these biofilms. Secondary outcomes include the association between biofilm formation, postoperative infections (such as empyema or wound infection), and the length of hospital stay.

This study will be conducted at Ondokuz Mayıs University Faculty of Medicine, Department of Thoracic Surgery, in collaboration with the Department of Microbiology. The findings are expected to contribute to better understanding of optimal drain management and infection prevention strategies after thoracic surgery.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age 18 years and older
  • Undergoing elective thoracic surgery requiring chest drain placement
  • Able and willing to provide written informed consent

Exclusion Criteria

  • Presence of active infection prior to surgery
  • Emergency thoracic surgery
  • Immunosuppressed patients (e.g., neutropenia, advanced malignancy, organ transplantation)
  • Patients receiving systemic antibiotic therapy at the time of drain removal
  • Drainage for empyema or pre-existing pleural infection
  • Presence of extrathoracic infection focus
  • Refusal or inability to provide informed consent

Outcomes

Primary Outcomes

Presence and Intensity of Biofilm Formation on Chest Drain Tips

Time Frame: At the time of chest drain removal (postoperative days 1-7)

Biofilm formation on the inner surface of chest drain tips will be evaluated using a microplate crystal violet staining method. The optical density (OD) at 492 nm will be measured, and biofilm intensity will be classified according to the Christensen and Chusri scale (non, weak, moderate, strong). The proportion of patients with biofilm-positive drain tips will be recorded and compared across drain duration groups.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Caner İşevi, MD
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Caner İşevi, MD

Principal Investigator

Ondokuz Mayıs University

Study Sites (1)

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