Internally coated endotracheal tubes with silver sulfadiazine in polyurethane to prevent bacterial colonization: a clinical trial

Objective: Coated medical devices have been shown to reduce catheter-related infections. We coated endotracheal tubes (ETT) with silver sulfadiazine (SSD), and tested them in a clinical study to assess the feasibility, safety, and efficacy of preventing bacterial colonization. Design: A prospective, randomized clinical trial, phase I-II. Setting: Academic intensive care unit (ICU). Participants: Forty-six adult patients expected to need 12-24 h of intubation were randomized into two groups. Interventions: Patients were randomized to be intubated with a standard non-coated ETT (St-ETT, n = 23; control group), or with a SSD-coated ETT (SSD-ETT, n = 23). Measurements and results: Coating with SSD prevented bacterial colonization of the ETT (frequency of colonization: SSD-ETT 0/23, St-ETT 8/23; p < 0.01). No organized bacterial biofilm could be identified on the lumen of any ETT; however, SSD was associated with a thinner mucus layer (in the SSD-ETT secretion deposits ranged from 0 to 200 μm; in the St-ETT deposits ranged between 50 and 700 μm). No difference was observed between the two groups in the tracheobronchial brush samples (frequency of colonization: SSD-ETT 0/23, St-ETT 2/23; p = 0.48). No adverse reactions were observed with the implementation of the novel device. Conclusion: SSD-ETT can be safely used in preventing bacterial colonization and narrowing of the ETT in patients intubated for up to 24 h (mean intubation time 16 h). © 2008 Springer-Verlag.