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Effect of Antibiotic Prophylaxis on Surgical Site Infections Following Removal of Orthopedic Implants Used for Treatment of Foot, Ankle, and Lower Leg FracturesA Randomized Clinical Trial

Educational Objective
To learn whether antibiotic prophylaxis decreases the risk of surgical site infection after removal of orthopedic implants.
1 Credit CME
Key Points

Question  Does antibiotic prophylaxis with a single preoperative dose of intravenous cefazolin (1000 mg) reduce the risk of surgical site infection following removal of orthopedic implants used for treatment of fractures below the knee?

Findings  In this randomized clinical trial that included 470 patients who were undergoing surgery for removal of orthopedic implants used for treatment of below-the-knee fractures, surgical site infection occurred in 12.9% of patients in the cefazolin group and 14.9% of patients in the saline group, a nonsignificant difference.

Meaning  A single preoperative dose of intravenous cefazolin did not reduce the risk of surgical site infection within 30 days following removal of orthopedic implants used for treatment of fractures below the knee.

Abstract

Importance  Following clean (class I, not contaminated) surgical procedures, the rate of surgical site infection (SSI) should be less than approximately 2%. However, an infection rate of 12.2% has been reported following removal of orthopedic implants used for treatment of fractures below the knee.

Objective  To evaluate the effect of a single dose of preoperative antibiotic prophylaxis on the incidence of SSIs following removal of orthopedic implants used for treatment of fractures below the knee.

Design, Setting, and Participants  Multicenter, double-blind, randomized clinical trial including 500 patients aged 18 to 75 years with previous surgical treatment for fractures below the knee who were undergoing removal of orthopedic implants from 19 hospitals (17 teaching and 2 academic) in the Netherlands (November 2014-September 2016), with a follow-up of 6 months (final follow-up, March 28, 2017). Exclusion criteria were an active infection or fistula, antibiotic treatment, reimplantation of osteosynthesis material in the same session, allergy for cephalosporins, known kidney disease, immunosuppressant use, or pregnancy.

Interventions  A single preoperative intravenous dose of 1000 mg of cefazolin (cefazolin group, n = 228) or sodium chloride (0.9%; saline group, n = 242).

Main Outcomes and Measures  Primary outcome was SSI within 30 days as measured by the criteria from the US Centers for Disease Control and Prevention. Secondary outcome measures were functional outcome, health-related quality of life, and patient satisfaction.

Results  Among 477 randomized patients (mean age, 44 years [SD, 15]; women, 274 [57%]; median time from orthopedic implant placement, 11 months [interquartile range, 7-16]), 470 patients completed the study. Sixty-six patients developed an SSI (14.0%): 30 patients (13.2%) in the cefazolin group vs 36 in the saline group (14.9%) (absolute risk difference, −1.7 [95% CI, −8.0 to 4.6], P = .60).

Conclusions and Relevance  Among patients undergoing surgery for removal of orthopedic implants used for treatment of fractures below the knee, a single preoperative dose of intravenous cefazolin compared with saline did not reduce the risk of surgical site infection within 30 days following implant removal.

Trial Registration  clinicaltrials.gov Identifier: NCT02225821

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Article Information

Corresponding Author: Tim Schepers, Academic Medical Center, Trauma Unit, Department of Surgery, Meibergdreef 9, PO Box 22660, 1100 DD Amsterdam, the Netherlands (t.schepers@amc.nl).

Correction: This article was corrected for a typo on March 13, 2018.

Accepted for Publication: November 20, 2017.

Author Contributions: Drs Dingemans and Backes had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Drs Backes and Siem contributed equally to this work.

Concept and design: Backes, Dingemans, Dijkgraaf, Goslings, Schepers.

Acquisition, analysis, or interpretation of data: Backes, Dingemans, Dijkgraaf, van den Berg, van Dijkman, Hoogendoorn, Joosse, Ritchie, Roerdink, Schots, Sosef, Spijkerman, Twigt, vd Veen, van Veen, Vermeulen, Vos, Winkelhagen, Schepers.

Drafting of the manuscript: Backes, Dingemans, van Dijkman, vd Veen, van Veen, Schepers.

Critical revision of the manuscript for important intellectual content: Backes, Dingemans, Dijkgraaf, van den Berg, Hoogendoorn, Joosse, Ritchie, Roerdink, Schots, Sosef, Spijkerman, Twigt, vd Veen, van Veen, Vermeulen, Vos, Winkelhagen, Goslings, Schepers.

Statistical analysis: Backes, Dingemans.

Obtained funding: Backes, Dijkgraaf, Goslings, Schepers.

Administrative, technical, or material support: Backes, Dingemans, van den Berg, van Dijkman, Hoogendoorn, Ritchie, Roerdink, Schots, Sosef, Twigt, vd Veen, Vermeulen, Winkelhagen.

Supervision: Dijkgraaf, van Dijkman, Joosse, Sosef, Spijkerman, van Veen, Vermeulen, Vos, Winkelhagen, Goslings, Schepers.

Contributing in patients material: Vos.

Inclusion, treatment, and follow up: Twigt.

Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.

Funding/Support: This work was supported by grant 836031005 from the Netherlands Organization for Health Research and Development (ZonMw).

Role of the Funder/Sponsor: The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

The WIFI Collaboration Group includes the authors and the following individuals: Bech Niels H, MD (Onze Lieve Vrouwe Gasthuis [OLVG] East Amsterdam, the Netherlands); Bloemers Frank W, MD, PhD (VU University Medical Center Amsterdam, the Netherlands); Garssen Frank P, MD (Amstelland Hospital Amstelveen, the Netherlands); Hagemans Frans JA, MD (Flevo Hospitals Almere, the Netherlands); Haverlag Robert, MD (OLVG East Amsterdam, the Netherlands); Hogervorst Mike, MD (Gelre Hospitals Apeldoorn, the Netherlands); de Jong Vincent M, MD (Academic Medical Center Amsterdam, the Netherlands); Luitse Jan SK, MD (Academic Medical Center, Amsterdam, the Netherlands); Mirck Boj, MD (Red Cross Hospital Beverwijk, the Netherlands); Schep Niels WL, MD, PhD (Maasstad Hospital Rotterdam, the Netherlands); Soesman Nicolaj MR, MD, PhD (Vlietland Hospital Schiedam, the Netherlands); de Vries Eefje N, MD PhD (Academic Medical Center Amsterdam, the Netherlands); and Meij-de Vries Annebeth, MD, PhD (Red Cross Hospital Beverwijk, the Netherlands).

Additional Contributions: We thank all the participants in the trial, health care professionals who helped with enrollment, M. P. Merkus, PhD (Academic Medical Center, the Netherlands), for her contributions to the design of the study, S. van Dieren, PhD (Academic Medical Center, the Netherlands), for her contributions to the analysis of the study data, the staff at all the study centers for their help, and the members of the data and safety monitoring board who helped monitor the safety aspects of the trial.

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