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.


METHODS
A prospective, randomized clinical trial, phase I-II.


METHODS
Academic intensive care unit (ICU).


METHODS
Forty-six adult patients expected to need 12-24 h of intubation were randomized into two groups.


METHODS
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).


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 microm; in the St-ETT deposits ranged between 50 and 700 microm). 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.


CONCLUSIONS
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).
Berra
Lorenzo
L
Anesthesia and Critical Care, Massachusetts General Hospital, Harvard Medical School, 55 Fruit Street, Boston, MA 02114, USA. lberra@partners.org
Kolobow
Theodor
T
Laquerriere
Patrice
P
Pitts
Betsey
B
Bramati
Simone
S
Pohlmann
Joshua
J
Marelli
Chiara
C
Panzeri
Miriam
M
Brambillasca
Pietro
P
Villa
Federico
F
Baccarelli
Andrea
A
Bouthors
Sylvie
S
Stelfox
Henry T
HT
Bigatello
Luca M
LM
Moss
Joel
J
Pesenti
Antonio
A
D000368:Aged; D020099:Coated Materials, Biocompatible; D015169:Colony Count, Microbial; D004202:Disinfectants / Q000008:administration & dosage / Q000494:pharmacology*; D004866:Equipment Contamination / Q000517:prevention & control*; D005260:Female; D006801:Humans; D007442:Intubation, Intratracheal / Q000009:adverse effects / Q000295:instrumentation*; D008297:Male; D018613:Microscopy, Confocal; D008855:Microscopy, Electron, Scanning; D053717:Pneumonia, Ventilator-Associated / Q000517:prevention & control*; D011140:Polyurethanes / Q000494:pharmacology; D011446:Prospective Studies; D012837:Silver Sulfadiazine / Q000008:administration & dosage / Q000494:pharmacology*; D018709:Statistics, Nonparametric; D012122:Ventilators, Mechanical / Q000009:adverse effects / Q000382:microbiology*
D020099:Coated Materials, Biocompatible; D004202:Disinfectants; D011140:Polyurethanes; D012837:Silver Sulfadiazine