Biofilm on Chest Drains After Thoracic Surgery: Clinical Impact and Antibiotic Resistance

November 16, 2025 updated by: Caner İşevi, MD

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

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 Overview

Study Type

Observational

Enrollment (Estimated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Samsun
      • Samsun, Samsun, Turkey (Türkiye), 55139
        • Recruiting
        • Ondokuz Mayis University Medical Faculty, Department of Thoracic Surgery
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients (≥18 years old) who undergo elective thoracic surgery at Ondokuz Mayıs University Faculty of Medicine and require postoperative chest drain placement. Participants are prospectively enrolled and observed until drain removal. Drain tip samples are collected for microbiological and biofilm analysis.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1 -Short Drain Duration (≤2 Days)
Participants whose thoracic chest drains were removed within 2 days after surgery. Drain tip samples from these patients will be analyzed for biofilm formation and microbiological culture.
No active intervention; routine chest drain removal followed by microbiological and biofilm analysis of drain tip samples.
Group 2 - Moderate Drain Duration (3-4 Days)
Participants whose thoracic chest drains remained in place for 3 to 4 days postoperatively. Drain tips will be examined for biofilm presence and bacterial growth patterns.
No active intervention; routine chest drain removal followed by microbiological and biofilm analysis of drain tip samples.
Group 3 - Long Drain Duration (≥5 Days)
Participants with chest drains in place for 5 days or longer. Biofilm formation, bacterial species identification, and antibiotic resistance profiles will be evaluated.
No active intervention; routine chest drain removal followed by microbiological and biofilm analysis of drain tip samples.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the time of chest drain removal (postoperative days 1-7)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

November 13, 2025

First Submitted That Met QC Criteria

November 13, 2025

First Posted (Estimated)

November 14, 2025

Study Record Updates

Last Update Posted (Actual)

November 19, 2025

Last Update Submitted That Met QC Criteria

November 16, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • B.30.2.ODM.0.20.08/600-660

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared because the dataset includes sensitive clinical and microbiological information collected from a single-center study. Data will be used only for the approved research protocol and analyzed in aggregate form to protect participant confidentiality in accordance with institutional and national data protection regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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