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27.04.2019 | Original Article

Antimicrobial prophylaxis for 1 day versus 3 days in liver cancer surgery: a randomized controlled non-inferiority trial

Zeitschrift:
Surgery Today
Autoren:
Tadatoshi Takayama, Osamu Aramaki, Taro Shibata, Masaaki Oka, Toshiyuki Itamoto, Mitsuo Shimada, Shuji Isaji, Takashi Kanematsu, Shoji Kubo, Masato Kusunoki, Hidetaka Mochizuki, Yoshinobu Sumiyama
Wichtige Hinweise

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1007/​s00595-019-01813-w) contains supplementary material, which is available to authorized users.
This Study Was Registered With the University Hospital Medical Information Network (UMIN)-CTR (https://​www.​umin.​ac.​jp), Identification Number 000002852.

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Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations

Abstract

Purposes

This study compared the effectiveness of 1-day vs 3-days antibiotic regimen to prevent surgical site infection (SSI) in open liver resection.

Method

We performed a randomized controlled non-inferiority trial in 480 patients at 39 hospitals across Japan (registered as UMIN000002852). Patients with hepatocellular carcinoma scheduled to undergo resection were randomly assigned to receive either a 1-day regimen for antimicrobial prophylaxis, or a 3-day regimen. The primary endpoint was the incidence of SSI.

Results

Among 480 randomized patients, 232 assigned to the 1-day regimen and 235 to the 3-day regimen were included in the full analysis set. Baseline characteristics of the two groups were well balanced. SSI was diagnosed in 22 patients (9.5%) in the 1-day group vs 23 patients (9.8%) in the 3-day group (difference, – 0.30; 90% CI – 4.80 to 4.19% [95% CI – 5.66% to 5.05%]; one-sided P = 0.001 for non-inferiority), meeting the non-inferiority hypothesis. In both groups, remote site infection (16 [6.9%] vs 22 [9.4%], P ˂ 0.001 for non-inferiority) and drain-related infection (5 [2.2%] vs 4 [1.7%], P ˂ 0.001 for non-inferiority) were comparable.

Conclusion

To prevent SSI in liver cancer surgery, a 1-day regimen of flomoxef sodium is recommended for antimicrobial prophylaxis because of confirming the non-inferiority to longer usage.

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Supplementary material 1 (TIF 97 kb)
595_2019_1813_MOESM1_ESM.tif
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