BiofilmsNCT07228598
Biofilm on Chest Drains After Thoracic Surgery: Clinical Impact and Antibiotic Resistance
An observational study of Biofilms and Thoracic Surgery, run by Caner İşevi, MD at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biofilms, Thoracic Surgery, Postoperative Infection
- What is being tested?
- Chest Drain Tip Sampling
- How many people
- 165 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2025to 1 Oct 2026
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age 18 years and older
- Undergoing elective thoracic surgery requiring chest drain placement
- Able and willing to provide written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayis University Medical Faculty, Department of Thoracic Surgery
Samsun, Samsun, 55139
About this study
Official title: 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.
- Being tested
- Chest Drain Tip Sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest Drain Tip SamplingOther
No active intervention; routine chest drain removal followed by microbiological and biofilm analysis of drain tip samples.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Chest Drain Tip Sampling | |
| 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. Receives: Other: Chest Drain Tip Sampling | |
| 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. Receives: Other: Chest Drain Tip Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence and Intensity of Biofilm Formation on Chest Drain Tips
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.
Measured: At the time of chest drain removal (postoperative days 1-7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study start1 Oct 2025
- Primary completion1 Sep 2026
- Study completion1 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BiofilmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 165 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Caner İşevi, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Caner İşevi, MD, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07228598
- Sponsor's protocol ID
- B.30.2.ODM.0.20.08/600-660
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biofilm Formation on Thoracic Drains: Clinical Significance and Association With Antibiotic Resistance
- ClinicalTrials.gov ID
- NCT07228598
- Acronym / sponsor ID
- B.30.2.ODM.0.20.08/600-660
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Caner İşevi, MDUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 14 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 -Short Drain Duration (≤2 Days) | – | Other: Chest Drain Tip SamplingParticipants 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. |
| Group 2 - Moderate Drain Duration (3-4 Days) | – | Other: Chest Drain Tip SamplingParticipants 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. |
| Group 3 - Long Drain Duration (≥5 Days) | – | Other: Chest Drain Tip SamplingParticipants with chest drains in place for 5 days or longer. Biofilm formation, bacterial species identification, and antibiotic resistance profiles will be evaluated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age 18 years and older
- Undergoing elective thoracic surgery requiring chest drain placement
- Able and willing to provide written informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest Drain Tip SamplingNo active intervention; routine chest drain removal followed by microbiological and biofilm analysis of drain tip samples. | Other | Group 1 -Short Drain Duration (≤2 Days), Group 2 - Moderate Drain Duration (3-4 Days), Group 3 - Long Drain Duration (≥5 Days) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biofilms and Thoracic Surgery, run by Caner İşevi, MD at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence and Intensity of Biofilm Formation on Chest Drain Tips (time frame: At the time of chest drain removal (postoperative days 1-7)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.