Manouk Backes1, Siem A Dingemans1, Marcel G W Dijkgraaf2, H Rogier van den Berg3, Bart van Dijkman4, Jochem M Hoogendoorn5, Pieter Joosse6, Ewan D Ritchie7, W Herbert Roerdink8, Judith P M Schots9, Nico L Sosef10, Ingrid J B Spijkerman11, Bas A Twigt12, Alexander H van der Veen9, Ruben N van Veen13, Jefrey Vermeulen14, Dagmar I Vos15, Jasper Winkelhagen16, J Carel Goslings1, Tim Schepers1. 1. Trauma Unit, Department of Surgery, Academic Medical Center Amsterdam, the Netherlands. 2. Clinical Research Unit, Academic Medical Center, Amsterdam, the Netherlands. 3. Department of Surgery, Onze Lieve Vrouwe Gasthuis East Amsterdam, the Netherlands. 4. Department of Surgery, Flevo Hospital, Almere, the Netherlands. 5. Department of Surgery, Haaglanden Medical Center Den Haag, the Netherlands. 6. Department of Surgery, Medical Center Alkmaar Alkmaar, the Netherlands. 7. Department of Surgery, Alrijne Hospital Leiderdorp, the Netherlands. 8. Department of Surgery, Deventer Hospital Deventer, the Netherlands. 9. Department of Surgery, Catharina Hospital Eindhoven, the Netherlands. 10. Department of Surgery, Spaarne Gasthuis Hoofddorp, the Netherlands. 11. Department of Microbiology, Academic Medical Center Amsterdam, the Netherlands. 12. Department of Surgery, BovenIJ Hospital Amsterdam, the Netherlands. 13. Department of Surgery, Onze Lieve Vrouwe Gasthuis West Amsterdam, the Netherlands. 14. Department of Surgery, Spaarne Gasthuis Haarlem, the Netherlands. 15. Department of Surgery, Amphia Hospital Breda, the Netherlands. 16. Department of Surgery, Westfries Gasthuis Hoorn, the Netherlands.
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 (cefazolingroup, 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.
RCT Entities:
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.
Authors: Fay R K Sanders; Diederick Penning; Manouk Backes; Siem A Dingemans; Susan van Dieren; Anne M Eskes; J Carel Goslings; Peter Kloen; Ron A A Mathôt; Niels W L Schep; Ingrid J B Spijkerman; Tim Schepers Journal: BMC Surg Date: 2021-02-01 Impact factor: 2.102
Authors: Siem A Dingemans; Ingrid J B Spijkerman; Merel F N Birnie; J Carel Goslings; Tim Schepers Journal: Arch Orthop Trauma Surg Date: 2018-07-10 Impact factor: 3.067
Authors: Adina Fésüs; Ria Benkő; Mária Matuz; Orsolya Kungler-Gorácz; Márton Á Fésüs; Tamás Bazsó; Zoltán Csernátony; Gábor Kardos Journal: Antibiotics (Basel) Date: 2021-12-09