Maximal sterile barrier precautions do not reduce catheter-related bloodstream infections in general surgery units: a multi-institutional randomized controlled trial.
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.


BACKGROUND
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.
Department of Surgery, Nippon Medical School, Tokyo, Japan.
Yoshinori
Y
Ishikawa
Teruo
T
Kiyama
Yoshio
Y
Haga
Masashi
M
Ishikawa
Hitoshi
H
Takeuchi
Osamu
O
Kimura
Yasushi
Y
Harihara
Kohki
K
Sunouchi
Takumi
T
Furuya
Masami
M
Kimura
D016470:Bacteremia / Q000517:prevention & control*; D055499:Catheter-Related Infections / Q000517:prevention & control*; D002405:Catheterization, Central Venous / Q000009:adverse effects*; D002408:Catheters, Indwelling / Q000009:adverse effects; D003428:Cross Infection / Q000517:prevention & control; D006801:Humans; D013242:Sterilization