A Phase 4 interventional study of Chlorhexidine Gluconate 0.12 % Mouthwash in Endobronchial Ultrasound, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2022-02-15.
Sponsored by Seoul National University Hospital · Phase 4, Interventional, and Prevention
The purpose of this study is to investigate whether chlorhexidine mouthrinse is effective in preventing microbial contamination during endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA).
EBUS-TBNA using the convex probe is a standard of care for the assessment of mediastinal and hilar lymphadenopathy. Although EBUS-TBNA is a minimally invasive procedure, rare but serious infectious complications such as pneumonia, lung abscess, empyema, mediastinal adenitis/abscess, mediastinitis, pericarditis, and sepsis were reported. EBUS-scope might be contaminated with oropharyngeal commensal bacteria while passing the oropharyngeal airway during EBUS-TBNA. Contamination of punctured lymph nodes by oropharyngeal commensal bacteria can cause severe infections.
Chlorhexidine gluconate is an antimicrobial agent that has a broad antibacterial activity including both gram-positive and negative bacteria. Chlorhexidine has been widely used for surgical scrub, skin disinfection, and mouthrinse. We, therefore, designed a phase 4, single-center, randomized, controlled clinical trial to investigate whether chlorhexidine mouthrinse is effective in preventing microbial contamination during EBUS-TBNA.
Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Mouthrinse with 100 ml 0.12% chlorhexidine for 1 min
Drug: Chlorhexidine Gluconate 0.12 % Mouthwash
No mouthrinse
Intervention with chlorhexidine mouthrinse will be performed approximately 10 min before the start of EBUS-TBNA
Also known as: Hexamedine Sol.
Colony forming unit (CFU) counts of EBUS-TBNA needle wash solution in aerobic media
Needle wash solution is obtained by instilling 5mL of sterile physiological saline into the puncture needle.
Time frame: Needle wash solution is obtained immediately after termination of EBUS-TBNA
CFU counts of EBUS-TBNA needle wash solution in anaerobic media
Needle wash solution is obtained by instilling 5mL of sterile physiological saline into the puncture needle.
Time frame: Needle wash solution is obtained immediately after termination of EBUS-TBNA
Fever
Fever is defined as a temperature ≥37.8°C.
Time frame: 24 hours after EBUS-TBNA
Infectious complications
Infectious complications include pneumonia, lung abscess, empyema, mediastinal adenitis/abscess, mediastinitis, pericarditis, and sepsis.
Time frame: 4 weeks after EBUS-TBNA
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital