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Maximal Sterile Barrier Precautions Do Not Reduce Catheter-Related Bloodstream Infections in General Surgery Units: A Multi-Institutional Randomized Controlled Trial

Ishikawa, Yoshinori MD*; Kiyama, Teruo MD*; Haga, Yoshio MD†; Ishikawa, Masashi MD‡; Takeuchi, Hitoshi MD§; Kimura, Osamu MD¶; Harihara, Yasushi MD∥; Sunouchi, Kohki MD**; Furuya, Takumi MD††; Kimura, Masami MD‡‡

doi: 10.1097/SLA.0b013e3181d48a6a
Radomized Controlled Trials

Objective: To investigate whether maximal sterile barrier precautions (MSBPs) during central venous catheter (CVC) insertion are truly effective in preventing catheter-related bloodstream infections (CRBSIs) in patients in general surgical units.

Summary Background Data: The reported effectiveness of MSBPs was based on the results of a single-center randomized controlled trial by Raad et al and the majority of the patients (99%) in the study were chemotherapy outpatients.

Methods: Between March 14, 2004 and December 28, 2006, the patients scheduled for CVC insertion in surgical units at 9 medical centers in Japan were randomly assigned to either an MSBP group (n = 211) or a standard sterile barrier precaution (SSBP) group (n = 213). This study was registered in the UMIN Clinical Trials Registry (registration ID number: UMIN000001400).

Results: The median (range) duration of catheterization was 14 days (0–92 days) in the MSBP group and 14 days (0–112 days) in the SSBP group. There were 5 cases (2.4%) of CRBSI in the MSBP group and 6 cases (2.8%) in the SSBP group (relative risk, 0.84; 95% confidence interval, 0.26–2.7; P = 0.77). The rate of CRBSIs per 1000 catheter days was 1.5 in the MSBP group and 1.6 in the SSBP group. There were 8 cases (3.8%) of catheter-related infections in the MSBP group and 7 cases (3.3%) in the SSBP group (relative risk, 1.2; 95% confidence interval, 0.43–3.1; P = 0.78). The rate of catheter-related infection per 1000 catheter days was 2.4 in the MSBP group and 1.9 in the SSBP group.

Conclusions: This study is larger in sample size than the one performed by Raad et al and could not demonstrate better prevention of CRBSIs by MSBP compared with SSBP. A large randomized controlled trial or at least a meta-analysis of any other studies in the literature is necessary to reach to a conclusion on this issue.

We conducted a randomized controlled trial to investigate whether maximal sterile barrier precautions during central venous catheter insertion effectively prevent catheter-related bloodstream infections in patients in general surgical units. However, this study did not demonstrate superiority over standard sterile barrier precautions in preventing catheter-related bloodstream infections.

From the *Department of Surgery, Nippon Medical School, Tokyo, Japan; †Department of Surgery, National Hospital Organization, Kumamoto Medical Center, Kumamoto, Japan; ‡Department of Surgery, Tokushima Red Cross Hospital, Tokushima, Japan; §Department of Surgery, National Hospital Organization, Iwakuni Clinical Center, Iwakuni, Japan; ¶Department of Surgery, National Hospital Organization, Yonago Medical Center, Yonago, Japan; ∥Department of Surgery, NTT East Japan Kanto Hospital, Tokyo, Japan; **Department of Surgery, Kawakita General Hospital, Tokyo, Japan; ††Department of Surgery, National Hospital Organization, Kanmon Medical Center, Shimonoseki, Japan; and ‡‡Department of Surgery, Health Insurance Hitoyoshi General Hospital, Kumamoto, Japan.

Health Science Research Grants for Research on Medical Technology Assessment and Comprehensive Research on Aging and Health from the Ministry of Health, Labour, and Welfare of Japan.

Ministry of Health, Labor, and Welfare of Japan.

Reprints: Yoshio Haga, MD, Department of Surgery, National Hospital Organization, Kumamoto Medical Center, 1–5 Ninomaru, Kumamoto 860–0008, Japan. E-mail: yoshio@kumamoto.hosp.go.jp.

© 2010 Lippincott Williams & Wilkins, Inc.