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

NCT07228598 | Recruiting

• 1 other identifier: B.30.2.ODM.0.20.08/600-660
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Biofilms; Thoracic Surgery; Postoperative Infection; Antibiotic Resistance, Bacterial

Outcome Measures

Primary Outcomes (1)

• 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.

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

Study Arms (3)

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.

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.

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.

Other: Chest Drain Tip Sampling

Interventions

Chest Drain Tip Sampling OTHER

No active intervention; routine chest drain removal followed by microbiological and biofilm analysis of drain tip samples.

Group 1 -Short Drain Duration (≤2 Days); Group 2 - Moderate Drain Duration (3-4 Days); Group 3 - Long Drain Duration (≥5 Days)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Caner İşevi, MD: lead

Study Sites (1)

Ondokuz Mayis University Medical Faculty, Department of Thoracic Surgery

Samsun, Samsun, 55139, Turkey (Türkiye)

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Small sections of chest drain tips will be collected for microbiological culture and biofilm analysis. No genetic or DNA-based testing will be performed.

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 14, 2025
• Study Start: October 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)