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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 Fractures: A Randomized Clinical Trial.

Abstract 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.
PMID
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Authors

Mayor MeshTerms
Keywords
Journal Title jama
Publication Year Start




PMID- 29279933
OWN - NLM
STAT- In-Process
LR  - 20171228
IS  - 1538-3598 (Electronic)
IS  - 0098-7484 (Linking)
VI  - 318
IP  - 24
DP  - 2017 Dec 26
TI  - Effect of Antibiotic Prophylaxis on Surgical Site Infections Following Removal of
      Orthopedic Implants Used for Treatment of Foot, Ankle, and Lower Leg Fractures: A
      Randomized Clinical Trial.
PG  - 2438-2445
LID - 10.1001/jama.2017.19343 [doi]
AB  - 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.
FAU - Backes, Manouk
AU  - Backes M
AD  - Trauma Unit, Department of Surgery, Academic Medical Center Amsterdam, the
      Netherlands.
FAU - Dingemans, Siem A
AU  - Dingemans SA
AD  - Trauma Unit, Department of Surgery, Academic Medical Center Amsterdam, the
      Netherlands.
FAU - Dijkgraaf, Marcel G W
AU  - Dijkgraaf MGW
AD  - Clinical Research Unit, Academic Medical Center, Amsterdam, the Netherlands.
FAU - van den Berg, H Rogier
AU  - van den Berg HR
AD  - Department of Surgery, Onze Lieve Vrouwe Gasthuis East Amsterdam, the
      Netherlands.
FAU - van Dijkman, Bart
AU  - van Dijkman B
AD  - Department of Surgery, Flevo Hospital, Almere, the Netherlands.
FAU - Hoogendoorn, Jochem M
AU  - Hoogendoorn JM
AD  - Department of Surgery, Haaglanden Medical Center Den Haag, the Netherlands.
FAU - Joosse, Pieter
AU  - Joosse P
AD  - Department of Surgery, Medical Center Alkmaar Alkmaar, the Netherlands.
FAU - Ritchie, Ewan D
AU  - Ritchie ED
AD  - Department of Surgery, Alrijne Hospital Leiderdorp, the Netherlands.
FAU - Roerdink, W Herbert
AU  - Roerdink WH
AD  - Department of Surgery, Deventer Hospital Deventer, the Netherlands.
FAU - Schots, Judith P M
AU  - Schots JPM
AD  - Department of Surgery, Catharina Hospital Eindhoven, the Netherlands.
FAU - Sosef, Nico L
AU  - Sosef NL
AD  - Department of Surgery, Spaarne Gasthuis Hoofddorp, the Netherlands.
FAU - Spijkerman, Ingrid J B
AU  - Spijkerman IJB
AD  - Department of Microbiology, Academic Medical Center Amsterdam, the Netherlands.
FAU - Twigt, Bas A
AU  - Twigt BA
AD  - Department of Surgery, BovenIJ Hospital Amsterdam, the Netherlands.
FAU - van der Veen, Alexander H
AU  - van der Veen AH
AD  - Department of Surgery, Catharina Hospital Eindhoven, the Netherlands.
FAU - van Veen, Ruben N
AU  - van Veen RN
AD  - Department of Surgery, Onze Lieve Vrouwe Gasthuis West Amsterdam, the
      Netherlands.
FAU - Vermeulen, Jefrey
AU  - Vermeulen J
AD  - Department of Surgery, Spaarne Gasthuis Haarlem, the Netherlands.
FAU - Vos, Dagmar I
AU  - Vos DI
AD  - Department of Surgery, Amphia Hospital Breda, the Netherlands.
FAU - Winkelhagen, Jasper
AU  - Winkelhagen J
AD  - Department of Surgery, Westfries Gasthuis Hoorn, the Netherlands.
FAU - Goslings, J Carel
AU  - Goslings JC
AD  - Trauma Unit, Department of Surgery, Academic Medical Center Amsterdam, the
      Netherlands.
FAU - Schepers, Tim
AU  - Schepers T
AD  - Trauma Unit, Department of Surgery, Academic Medical Center Amsterdam, the
      Netherlands.
CN  - WIFI Collaboration Group
LA  - eng
SI  - ClinicalTrials.gov/NCT02225821
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - JAMA
JT  - JAMA
JID - 7501160
EDAT- 2017/12/28 06:00
MHDA- 2017/12/28 06:00
CRDT- 2017/12/28 06:00
PHST- 2017/12/28 06:00 [entrez]
PHST- 2017/12/28 06:00 [pubmed]
PHST- 2017/12/28 06:00 [medline]
AID - 2667070 [pii]
AID - 10.1001/jama.2017.19343 [doi]
PST - ppublish
SO  - JAMA. 2017 Dec 26;318(24):2438-2445. doi: 10.1001/jama.2017.19343.