NCT04718922

Chlorhexidine Mouthrinse Before EBUS-TBNA

Effect of Chlorhexidine Mouthrinse on Prevention of Microbial Contamination During EBUS-TBNA: a Randomized Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Endobronchial Ultrasound

Interventions

Type	Name	Description
DRUG	Chlorhexidine Gluconate 0.12 % Mouthwash	Intervention with chlorhexidine mouthrinse will be performed approximately 10 min before the start of EBUS-TBNA

Timeline

• Start date: 2021-01-20
• Primary completion: 2021-06-11
• Completion: 2021-12-11
• First posted: 2021-01-22
• Last updated: 2022-02-15

Locations

1 site across 1 country: South Korea