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A Randomized Controlled Trial

Jean-François Timsit, MD, PhD; Carole Schwebel, MD, PhD; Lila Bouadma, MD; Arnaud Geffroy, MD; Maïté Garrouste-Orgeas, MD; Sebastian Pease, MD; Marie-Christine Herault, MD; Hakim Haouache, MD; Silvia Calvino-Gunther, RN; Brieuc Gestin, PhD; Laurence Armand-Lefevre, PharmD; Véronique Leflon, PharmD; Chantal Chaplain, PharmD; Adel Benali, MD; Adrien Francais, MSc; Christophe Adrie, MD, PhD; Jean-Ralph Zahar, MD; Marie Thuong, MD; Xavier Arrault, PharmD; Jacques Croize, PharmD; Jean-Christophe Lucet, MD, PhD; for the Dressing Study Group

JAMA. 2009;301(12):1231-1241.

Context  Use of a chlorhexidine gluconate–impregnated sponge (CHGIS) in intravascular catheter dressings may reduce catheter-related infections (CRIs). Changing catheter dressings every 3 days may be more frequent than necessary.

Objective  To assess superiority of CHGIS dressings regarding the rate of major CRIs (clinical sepsis with or without bloodstream infection) and noninferiority (less than 3% colonization-rate increase) of 7-day vs 3-day dressing changes.

Design, Setting, and Patients  Assessor-blind, 2 x 2 factorial, randomized controlled trial conducted from December 2006 through June 2008 and recruiting patients from 7 intensive care units in 3 university and 2 general hospitals in France. Patients were adults (>18 years) expected to require an arterial catheter, central-vein catheter, or both inserted for 48 hours or longer.

Interventions  Use of CHGIS vs standard dressings (controls). Scheduled change of unsoiled adherent dressings every 3 vs every 7 days, with immediate change of any soiled or leaking dressings.

Main Outcome Measures  Major CRIs for comparison of CHGIS vs control dressings; colonization rate for comparison of 3- vs 7-day dressing changes.

Results  Of 2095 eligible patients, 1636 (3778 catheters, 28 931 catheter-days) could be evaluated. The median duration of catheter insertion was 6 (interquartile range [IQR], 4-10) days. There was no interaction between the interventions. Use of CHGIS dressings decreased the rates of major CRIs (10/1953 [0.5%], 0.6 per 1000 catheter-days vs 19/1825 [1.1%], 1.4 per 1000 catheter-days; hazard ratio [HR], 0.39 [95% confidence interval {CI}, 0.17-0.93]; P = .03) and catheter-related bloodstream infections (6/1953 catheters, 0.40 per 1000 catheter-days vs 17/1825 catheters, 1.3 per 1000 catheter-days; HR, 0.24 [95% CI, 0.09-0.65]). Use of CHGIS dressings was not associated with greater resistance of bacteria in skin samples at catheter removal. Severe CHGIS-associated contact dermatitis occurred in 8 patients (5.3 per 1000 catheters). Use of CHGIS dressings prevented 1 major CRI per 117 catheters. Catheter colonization rates were 142 of 1657 catheters (7.8%) in the 3-day group (10.4 per 1000 catheter-days) and 168 of 1828 catheters (8.6%) in the 7-day group (11.0 per 1000 catheter-days), a mean absolute difference of 0.8% (95% CI, –1.78% to 2.15%) (HR, 0.99; 95% CI, 0.77-1.28), indicating noninferiority of 7-day changes. The median number of dressing changes per catheter was 4 (IQR, 3-6) in the 3-day group and 3 (IQR, 2-5) in the 7-day group (P < .001).

Conclusions  Use of CHGIS dressings with intravascular catheters in the intensive care unit reduced risk of infection even when background infection rates were low. Reducing the frequency of changing unsoiled adherent dressings from every 3 days to every 7 days modestly reduces the total number of dressing changes and appears safe.

Trial Registration  clinicaltrials.gov Identifier: NCT00417235

Author Affiliations: INSERM U823; University Joseph Fourier, Albert Bonniot Institute, Grenoble CEDEX, France (Dr Timsit, Ms Calvino-Gunther, and Mr Francais); Medical Intensive Care Unit, Albert Michallon University Hospital, Grenoble, France (Drs Timsit and Schwebel and Ms Calvino-Gunther); Medical Intensive Care Unit (Dr Bouadma), Surgical Intensive Care Unit (Dr Geffroy), Bacteriology Department (Dr Armand-Lefevre), Drug Delivery Department (Dr Arrault), and Infection Control Unit (Dr Lucet), Bichat-Claude Bernard University Hospital, Paris, France; Medical-Surgical Intensive Care Unit (Dr Garrouste-Orgeas) and Microbiology Department (Dr Benali), Saint Joseph Hospital Network, Paris, France; Surgical Intensive Care Unit (Dr Pease) and Microbiology Department (Dr Leflon), Beaujon University Hospital, Clichy, France; Surgical Intensive Care Unit (Dr Herault) and Micro-Biology Department (Drs Gestin and Croize), Grenoble University Hospital, Grenoble, France; Medical-Surgical Intensive Care Unit (Dr Haouache) and Microbiology Department (Dr Chaplain), Delafontaine Hospital, Saint Denis, France; Physiology Department, Cochin Hospital, Paris, France (Dr Adrie); Micro-Biology and Hygiene, Necker Hospital, Paris, France (Dr Zahar); National Biomedecine Agency, Saint Denis la Plaine, France (Dr Thuong); and Assistance-Publique Hôpitaux de Paris and University Paris VII Denis Diderot, Paris, France (Dr Lucet).

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