- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07228598
Biofilm on Chest Drains After Thoracic Surgery: Clinical Impact and Antibiotic Resistance
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
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Samsun
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Samsun, Samsun, Turkey (Türkiye), 55139
- Recruiting
- Ondokuz Mayis University Medical Faculty, Department of Thoracic Surgery
-
Contact:
- Caner İşevi, MD
- Phone Number: 4240 03623121919
- Email: drcanerisevi@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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