TY - JOUR
T1 - 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
AU - Backes, Manouk
AU - Dingemans, Siem A.
AU - Dijkgraaf, Marcel G. W.
AU - van den Berg, H. Rogier
AU - van Dijkman, Bart
AU - Hoogendoorn, Jochem M.
AU - Joosse, Pieter
AU - Ritchie, Ewan D.
AU - Roerdink, W. Herbert
AU - Schots, Judith P. M.
AU - Sosef, Nico L.
AU - Spijkerman, Ingrid J. B.
AU - Twigt, Bas A.
AU - van der Veen, Alexander H.
AU - van Veen, Ruben N.
AU - Vermeulen, Jefrey
AU - Vos, Dagmar I.
AU - Winkelhagen, Jasper
AU - Goslings, J. Carel
AU - Schepers, Tim
AU - WIFI Collaboration Group
AU - Niels, Bech H.
AU - Frank, Bloemers W.
AU - Frank, Garssen P.
AU - Frans, Hagemans J. A.
AU - Robert, Haverlag
AU - Mike, Hogervorst
AU - de Jong Vincent, M.
AU - Jan, Luitse S. K.
AU - Boj, Mirck
AU - Niels, Schep W. L.
AU - Nicolaj, Soesman M. R.
AU - de Vries Eefje, N.
AU - Vries Annebeth, Meij-de
AU - Bech, Niels
AU - Bloemers, Frank
AU - Garssen, Frank
AU - Hagemans, Frans
AU - Haverlag, Robert
AU - Hogervorst, Mike
AU - de Jong, Vincent
AU - Luitse, Jan
AU - Mirck, Boj
AU - Schep, Niels
AU - Soesman, Nicolaj
AU - de Vries, Eefje
AU - Meij-de Vries, Annebeth
PY - 2017
Y1 - 2017
N2 - 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. 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. 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. A single preoperative intravenous dose of 1000 mg of cefazolin (cefazolin group, n = 228) or sodium chloride (0.9%; saline group, n = 242). 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. 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). 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. clinicaltrials.gov Identifier: NCT02225821
AB - 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. 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. 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. A single preoperative intravenous dose of 1000 mg of cefazolin (cefazolin group, n = 228) or sodium chloride (0.9%; saline group, n = 242). 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. 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). 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. clinicaltrials.gov Identifier: NCT02225821
UR - https://www.scopus.com/pages/publications/85040064246
UR - https://www.ncbi.nlm.nih.gov/pubmed/29279933
U2 - 10.1001/jama.2017.19343
DO - 10.1001/jama.2017.19343
M3 - Article
C2 - 29279933
SN - 0098-7484
VL - 318
SP - 2438
EP - 2445
JO - JAMA
JF - JAMA
IS - 24
ER -
