Clinical science
The role of antibiotic prophylaxis in totally implantable venous access device placement: results of a single-center prospective randomized trial

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Abstract

Background

This study evaluated whether prophylactic treatment with a cefazolin could prevent infections in patients who had a surgically inserted totally implantable venous access device (TIVAD).

Methods

We conducted a prospective, randomized, double-blind, placebo-controlled trial comparing wound infection rates in 404 patients (203 received prophylactic cefazolin, 201 received a placebo) undergoing TIVAD insertion. Infections were evaluated 3, 7, 14, and 30 days after discharge and outcomes were compared and analyzed.

Results

Groups were well matched for all preoperative variables studied, including comorbid conditions. Superficial surgical site infection developed in 5 patients (2.5%) from the antibiotic group and 6 (3%) from the placebo group (P = .75). One from each group developed deep surgical site infection. Both patients were readmitted and underwent repeated debridement, which eventually resulted in port loss in 1 patient.

Conclusions

We do not recommend the use of prophylactic antibiotics in TIVAD insertion because they will not decrease the already low rate of postoperative infectious complications. Registration number NCT00867295 (http://www.clinicaltrials.gov).

Section snippets

Patients

A prospective, randomized, double-blind, placebo-controlled trial was conducted at the tertiary Istanbul University Institute of Oncology between September 2008 and December 2009. All patients who were referred to the authors (H.K., S.K.) for TIVAD insertion were considered as candidates for the trial. A total of 432 consecutive patients who met criteria for TIVAD implantation were randomly assigned either cefazolin or placebo.

Exclusion criteria were refusal to participate and other reasons

Patient characteristics

In total, 432 patients initially were enrolled in this study. Thirteen patients who had one or more of the exclusion criteria were excluded. In addition, 15 of 419 patients were excluded from the efficacy analysis because of a violation of the study protocol or failure to complete follow-up examinations. A total of 419 patients (cefazolin, 210; placebo, 209) constituted the intent-to-treat population, and 404 were valid for the efficacy analysis (Fig. 1). Ten patients who were not available for

Comments

The reported frequency of catheter-related infections in TIVADs varies from .6% to 27%.10, 11, 12, 13, 14, 16 Schwarz et al13 reported that the infection rate was 8.8% in 616 patients. Of the 62 infectious complications, 31 (50%) presented as sepsis, and 15 (24%) presented as local infections with cellulitis around the port. Thirty-seven (60%) ultimately necessitated removal of the catheter. Biffi et al17 reported on a series of 333 patients with TIVADs; the rate of surgical site infection was

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  • Does systemic antibiotic prophylaxis prior to the placement of totally implantable venous access devices reduce early infection? A retrospective study of 1,485 cases at a large academic institution

    2020, American Journal of Infection Control
    Citation Excerpt :

    In this study, patients either received prophylactic cefazolin (n = 203) or placebo (n = 201). The results from this study found no significant difference between superficial surgical site infection between the 2 groups with a P value of .75.22 The findings of our study, with a 0.54% 30-day TIVAD removal rate and a 2.90% TIVAD removal for all catheter-related bloodstream infections, are in-line with reported literature.

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