Effect of a Second-Generation Venous Catheter Impregnated with Chlorhexidine and Silver Sulfadiazine on Central Catheter–Related Infections

A Randomized, Controlled Trial

18 October 2005 | Volume 143 Issue 8 | Pages 570-580

Background: Central venous catheter–related infections are a significant medical problem. Improved preventive measures are needed.

Objective: To ascertain 1) effectiveness of a second-generation antiseptic-coated catheter in the prevention of microbial colonization and infection; 2) safety and tolerability of this device; 3) microbiology of infected catheters; and 4) propensity for the development of antiseptic resistance.

Design: Multicenter, randomized, double-blind, controlled trial.

Setting: 9 university-affiliated medical centers.

Patients: 780 patients in intensive care units who required central venous catheterization.

Intervention: Patients received either a standard catheter or a catheter coated with chlorhexidine and silver sulfadiazine.

Measurements: The authors assessed catheter colonization and catheter-related infection, characterized microbes by molecular typing, and determined their susceptibility to antiseptics. Patient tolerance of the catheter was monitored.

Results: Patients with the 2 types of catheters had similar demographic features, clinical interventions, laboratory values, and risk factors for infection. Antiseptic catheters were less likely to be colonized at the time of removal compared with control catheters (13.3 vs. 24.1 colonized catheters per 1000 catheter-days; P < 0.01). The center-stratified Cox regression hazard ratio for colonization controlling for sampling design and potentially confounding variables was 0.45 (95% CI, 0.25 to 0.78). The rate of definitive catheter-related bloodstream infection was 1.24 per 1000 catheter-days (CI, 0.26 to 3.62 per 1000 catheter-days) for the control group versus 0.42 per 1000 catheter-days (CI, 0.01 to 2.34 per 1000 catheter-days) for the antiseptic catheter group (P = 0.6). Coagulase-negative staphylococci and other gram-positive organisms were the most frequent microbes to colonize catheters. Noninfectious adverse events were similar in both groups. Antiseptic susceptibility was similar for microbes recovered from either group.

Limitations: The antiseptic catheter was not compared with an antibiotic-coated catheter, and no conclusion can be made regarding its effect on bloodstream infection.

Conclusions: The second-generation chlorhexidine–silver sulfadiazine catheter is well tolerated. Antiseptic coating appears to reduce microbial colonization of the catheter compared with an uncoated catheter.

Editors' Notes Context Bacterial colonization of central venous catheters is relatively common, and subsequent bacteremia is a serious iatrogenic complication of critical illness. Initial studies of antimicrobial-coated catheters have suggested that this approach might decrease catheter-associated infection. Contribution This randomized, double-blind, controlled study of a new antiseptic-coated catheter versus an uncoated catheter shows a substantial decrease in bacterial colonization in patients receiving the coated device. Caution The study was unable to show a substantial decrease in bloodstream infections, possibly because of the low infection rate as a result of meticulous aseptic techniques used during catheter insertion. —The Editors

 

Author and Article Information

From the University of Nebraska Medical Center, Omaha, Nebraska; Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts; Johns Hopkins University School of Medicine, Baltimore, Maryland; Hartford Hospital, Hartford, and University of Connecticut, Farmington, Connecticut; Rhode Island Hospital and Brown Medical School, Providence, Rhode Island; Rochester General Hospital, Rochester, New York; University of Washington, Seattle, Washington; University of Pittsburgh, Pittsburgh, Pennsylvania; University of Iowa, Iowa City, Iowa; University of Wisconsin, Madison, Wisconsin; and Wake Forest University, Winston-Salem, North Carolina.

Note: This study was presented in abstract form (Abstract K-2047) at the 41st Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, Illinois, 16–19 December 2001.

Acknowledgments: The authors thank the numerous persons at each of the participating centers who assisted with the conduct of this trial, including study coordinators, clinical nurses, and laboratory personnel. They also thank Dr. Orlando Morejon for initiating the trial at the University of Connecticut Health Center; Shaan Schaeffer at Arrow International for logistic support; and Alison Nelson, Mindy Liss, Greg Maislin, and Michael Feldstein for the statistical analysis of data.

Grant Support: By Arrow International, Inc.

Potential Financial Conflicts of Interest: Consultancies: J.M. Civetta (Arrow International), L.A. Mermel (3M); Honoraria: M.E. Rupp (Arrow International), T.M. Perl (Edwards Life Science), L.A. Mermel (3M); Grants received: M.E. Rupp (Arrow International), S.J. Lisco (Arrow International), T.M. Perl (Arrow International), K. Keating (Arrow International), J.M. Civetta (Arrow International), L.A. Mermel (3M, Johnson & Johnson, Micrologix), D. Lee (Arrow International), E.P. Dellinger (Arrow International), M. Donahoe (Arrow International), D. Giles (Arrow International), M.A. Pfaller (Arrow International), R. Sherertz (Arrow International).

Requests for Single Reprints: Mark E. Rupp, MD, 984031 Nebraska Medical Center, Omaha, NE 68198-4031; e-mail, merupp{at}unmc.edu.

Current Author Addresses: Dr. Rupp: 984031 Nebraska Medical Center, Omaha, NE 68198-4031.

Dr. Lisco: 350 Engle Street, Englewood, NJ 07631.

Dr. Lipsett: 600 N. Wolfe Street, Blalock 685, Baltimore, MD 21287-4685.

Dr. Perl: 600 N. Wolfe Street, 425 Osler, Baltimore, MD 21287-4425.

Dr. Keating: 80 Seymore Street, Hartford, CT 06102.

Dr. Civetta: 263 Farmington Avenue, Farmington, CT 06030.

Dr. Mermel: 593 Eddy Street, Providence, RI 02903.

Dr. Lee: 1425 Portland Avenue, Rochester, NY 14621.

Dr. Dellinger: 1959 NE Pacific Street, Seattle, WA 98195-6410.

Dr. Donahoe: 625 NW Montefiore University Hospital, 3459 Fifth Avenue, Pittsburgh, PA 15213.

Dr. Giles: 263 Farmington Avenue, Farmington, CT 06030.

Dr. Pfaller: C606B General Hospital, 200 Hawkins Drive, Iowa City, IA 52242-1009.

Dr. Maki: 600 Highland Avenue, H4/574 Box 5158, Madison, WI 53792-5158.

Dr. Sherertz: Section of Infectious Diseases, Medical Center Boulevard, Winston-Salem, NC 27157-1042.

Author Contributions: Conception and design: M.E. Rupp, S.J. Lisco, E.P. Dellinger, R. Sherertz.

Analysis and interpretation of the data: M.E. Rupp, T.M. Perl, J.M. Civetta, M.A. Pfaller, D.G. Maki.

Drafting of the article: M.E. Rupp, M. Donahoe, R. Sherertz.

Critical revision of the article for important intellectual content: M.E. Rupp, P.A. Lipsett, K. Keating, J.M. Civetta, L.A. Mermel, D. Lee, E.P. Dellinger, M. Donahoe, M.A. Pfaller, D.G. Maki, R. Sherertz.

Final approval of the article: M.E. Rupp, S.J. Lisco, P.A. Lipsett, T.M. Perl, K. Keating, J.M. Civetta, L.A. Mermel, D. Lee, E.P. Dellinger, M. Donahoe, D. Giles, M.A. Pfaller, D.G. Maki, R. Sherertz. Provision of study materials or patients: M.E. Rupp, S.J. Lisco, P.A. Lipsett, K. Keating, J.M. Civetta, L.A. Mermel, D. Lee, E.P. Dellinger, M. Donahoe, D. Giles. Statistical expertise: M.E. Rupp. Administrative, technical, or logistical support: T.M. Perl. Collection and assembly of data: M.E. Rupp, P.A. Lipsett, T.M. Perl, K. Keating, D. Lee, M.A. Pfaller.