A Prospective Randomized Study to Assess the Optimal Duration of Intravenous Antimicrobial Prophylaxis in Elective Gastric Cancer Surgery

Abstract The duration of antimicrobial prophylaxis in gastric cancer surgery is not yet established. This prospective randomized study was performed to confirm the noninferiority of single-dose versus multiple-dose antimicrobial prophylaxis in terms of the incidence of surgical-site infection in gastric cancer surgery. Three hundred twenty-five patients undergoing elective resection for gastric cancer were randomized to receive only single-dose cefazolin (1 g) during surgery (single-dose group) or an additional 5 doses every 12 hours postoperatively (multiple-dose group). The overall incidence of surgical-site infections was 9.1% in the single-dose group and 6.2% in the multiple-dose group [difference (95% confidence interval): −2.9% (−5.9%–0.0%)]. Multivariate logistic regression analysis identified blood loss, being overweight, and advanced age as significant independent risk factors for surgical-site infection. Single-dose antimicrobial prophylaxis seemed to be acceptable, and choosing multiple-dose prophylaxis may have little impact on the prevention of surgical-site infections in elective gastric cancer surgery.

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Effective prevention of surgical site infection using a Centers for Disease Control and Prevention guideline–based antimicrobial prophylaxis in lumbar spine surgery

Journal of Neurosurgery Spine ◽

10.3171/spi.2007.6.4.7 ◽

2007 ◽

Vol 6 (4) ◽

pp. 327-329 ◽

Cited By ~ 51

Author(s):

Masahiro Kanayama ◽

Tomoyuki Hashimoto ◽

Keiichi Shigenobu ◽

Fumihiro Oha ◽

Daisuke Togawa

Keyword(s):

Single Dose ◽

Lumbar Spine ◽

Surgical Site Infection ◽

Spine Surgery ◽

Multiple Dose ◽

Dose Group ◽

Antimicrobial Prophylaxis ◽

Lumbar Spine Surgery ◽

Site Infection ◽

Control And Prevention

Object Antimicrobial prophylaxis (AMP) reduces the rate of surgical site infection (SSI) in lumbar spine surgery, but a great deal of variation exists regarding the timing and duration of AMP. The authors had previously used prophylactic antibiotics for 5 to 7 postoperative days. Based on the Centers for Disease Control and Prevention (CDC) guideline, the AMP period was changed to the day of surgery only. In the current study, the authors compared the rate of SSI in lumbar spine surgeries between two different protocols of AMP. Methods Data from 1597 consecutive uninfected patients who had undergone lumbar spine surgery between January 1999 and September 2004 were reviewed. The pathophysiologies among these patients included disc herniation in 686, degenerative spondylolisthesis in 340, spinal stenosis in 259, failed lumbar surgeries in 73, degenerative scoliosis in 52, isthmic spondylolisthesis in 48, spinal trauma in 34, foraminal stenosis in 27, spinal tumor in 27, and miscellaneous in 51 patients. The rate of SSI was compared between the two AMP groups. There were 1133 patients in the multiple-dose group, and 464 patients in the single-dose group. The rate of instrumentation surgery was not statistically different between the multiple-dose group (43%) and the single-dose group (39%). The overall rate of SSI was 0.7%. The SSI rate was 0.8% in the multiple-dose group and 0.4% in the single-dose group; the difference between the two was not significant. Regarding the organisms of SSI, resistant strains of bacteria were cultured in five (83.3%) of six patients in the multiple-dose group, whereas none was cultured in the single-dose group. Conclusions Data in the current study did not demonstrate a difference in the rate of SSI between the two different AMP protocols. Based on the CDC guideline, a single dose of AMP was proven to be efficacious for the prevention of SSI in lumbar spine surgeries. A shorter duration of first-generation cephalosporin use may effectively prevent the emergence of antibiotic-resistant bacterial infection.

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A randomized phase III trial to determine the efficacy of postoperative antimicrobial prophylaxis in gastric cancer surgery (OGSG0501)

Journal of Clinical Oncology ◽

10.1200/jco.2009.27.15_suppl.e15576 ◽

2009 ◽

Vol 27 (15_suppl) ◽

pp. e15576-e15576

Author(s):

K. Inoue ◽

H. Imamura ◽

Y. Kimura ◽

K. Fujitani ◽

Y. Miyake ◽

...

Keyword(s):

Gastric Cancer ◽

Surgical Site Infection ◽

Infection Rate ◽

Distal Gastrectomy ◽

Antimicrobial Prophylaxis ◽

Cancer Surgery ◽

Phase Iii ◽

Site Infection ◽

Phase Iii Trial ◽

Gastric Cancer Surgery

e15576 Background: In Japan, antimicrobial prophylaxis (AMP) is typically administered for 3 to 4 days postoperatively in gastric cancer surgery. This far exceeds the recommended 24h or less laid out by the Centers for Disease Control (CDC) guidelines for the prevention of surgical-site infections, after a clean-contaminated operation. Methods: A multicenter randomized phase III trial was designed to evaluate the effect of postoperative AMP in gastric cancer surgery. Patients (pts) were required to have histologically proven gastric cancer which was curable by distal gastrectomy, be classifiable as ASA 1 or 2, and have adequate organ function. Pts were randomized to: (A) perioperative AMP (cefazolin 1g, at <30min before incision, every 3h intraoperative supplements) plus postoperative AMP (cefazolin 1g, twice daily for 2 postoperative days) or (B) perioperative AMP alone. Pts were stratified by institution and ASA. The primary endpoint was the incidence of surgical site infection (SSI). With 171 pts per arm, this study had 80% power to demonstrate non-inferiority with 5% margin of peri-AMP alone and 0.05 1-sided alpha. Results: 355 patients were recruited (A: 179, B: 176) in 7 centers between June 2005 and December 2007. The surgical-site infection rate was 9.0 percent (16 of 178) for peri-/post AMP and 4.5 percent (8 of 176) for peri-AMP alone, with no significant differences (Fisher's exact test: P=0.14, RR=1.98 [95%CI, 0.89–4.44]), but showing a significant non-inferiority (P<0.001). The remote site infection rate was 3.4 percent (6 of 178) for peri-/post AMP and 5.1 percent (9 of 175) for peri-AMP alone, with no significant differences (P=0.44, RR=0.66 [95%CI, 0.25- 1.70]). Conclusions: This multicenter randomized phase III trial confirms that postoperative AMP is unnecessary in patients undergoing distal gastrectomy for gastric cancer. No significant financial relationships to disclose.

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Randomized clinical trial of single-versus multiple-dose antimicrobial prophylaxis in gastric cancer surgery

British Journal of Surgery ◽

10.1002/bjs.5837 ◽

2007 ◽

Vol 94 (6) ◽

pp. 683-688 ◽

Cited By ~ 37

Author(s):

Y. Mohri ◽

H. Tonouchi ◽

M. Kobayashi ◽

K. Nakai ◽

M Kusunoki ◽

...

Keyword(s):

Gastric Cancer ◽

Clinical Trial ◽

Randomized Clinical Trial ◽

Multiple Dose ◽

Antimicrobial Prophylaxis ◽

Cancer Surgery ◽

Gastric Cancer Surgery ◽

Single Versus

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Single-dose antibiotic prophylaxis compared with multiple-dose protocol in clean pediatric neurosurgical interventions: a nonrandomized, historically controlled equivalence trial

Journal of Neurosurgery Pediatrics ◽

10.3171/2021.9.peds21416 ◽

2021 ◽

pp. 1-8

Author(s):

Esmaeil Mohammadi ◽

Sina Azadnajafabad ◽

Mehrdad Goudarzi ◽

Keyvan Tayebi Meybodi ◽

Farideh Nejat ◽

...

Keyword(s):

Single Dose ◽

Multiple Dose ◽

Antimicrobial Prophylaxis ◽

Meta Analysis ◽

Prophylactic Antibiotic ◽

Surgical Site Infections ◽

Pediatric Neurosurgery ◽

Total Cohort ◽

Neurosurgical Patients ◽

Tertiary Center

OBJECTIVE Guidelines recommend antimicrobial prophylaxis (AMP) preoperatively for "clean" spinal and cranial surgeries, while dose and timing remain controversial. The use of multiple-dose AMP for such surgeries is under debate in the pediatric context. In this clinical study, the authors aimed to compare single-dose with multiple-dose prophylactic antibiotic usage in cranial and spinal neurosurgical interventions of pediatric patients. METHODS All neurosurgical patients aged 28 days to 18 years who underwent surgery at a single tertiary center were assessed. Three cohorts (noninstrumented clean spinal, noninstrumented cranial, and instrumented cranial interventions), each of which comprised two 50-patient arms (i.e., single-dose AMP and multiple-dose AMP), were included after propensity score–matched retrospective sampling and power analysis. Records were examined for surgical site infections. Using a previously published meta-analysis as the prior and 80% acceptance of equivalence (margin of OR 0.88–1.13), logistic regression was carried out for the total cohort and each subcohort and adjusted for etiology by consideration of multiple-dose AMP as reference. RESULTS The overall sample included 300 age- and sex-matched patients who were evenly distributed in 3 bi-arm cohorts. There was no statistical intercohort difference based on etiology or type of operation (p < 0.05). Equivalence analysis revealed nondiscriminating results for the total cohort (adjusted OR 0.65, 95% CI 0.27–1.57) and each of the subcohorts (noninstrumented clean spinal, adjusted OR 0.65, 95% CI 0.12–3.44; noninstrumented cranial, adjusted OR 0.52, 95% CI 0.14–2.73; and instrumented cranial, adjusted OR 0.68, 95% CI 0.13–3.31). CONCLUSIONS No significant benefit for multiple-dose compared with single-dose AMPs in any of the pediatric neurosurgery settings could be detected. Since unnecessary antibiotic use should be avoided as much as possible, it seems that usage of single-dose AMP is indicated.

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