Fay R K Sanders1, Diederick Penning1, Manouk Backes1, Siem A Dingemans1, Susan van Dieren1, Anne M Eskes1, J Carel Goslings2, Peter Kloen3, Ron A A Mathôt4, Niels W L Schep5, Ingrid J B Spijkerman6, Tim Schepers7. 1. Trauma Surgery, Amsterdam UMC, Loc. AMC, G4-137, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands. 2. Trauma Surgery, OLVG, Loc. West, Jan Tooropstraat 164, 1061 AE, Amsterdam, The Netherlands. 3. Orthopedic Surgery, Amsterdam UMC, Loc. AMC, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands. 4. Hospital Pharmacy, Amsterdam UMC, Loc. AMC, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands. 5. Trauma Surgery, Maasstad Ziekenhuis, Maasstadweg 21, 3079 DZ, Rotterdam, The Netherlands. 6. Medical Microbiology, Amsterdam UMC, Loc. AMC, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands. 7. Trauma Surgery, Amsterdam UMC, Loc. AMC, G4-137, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands. t.schepers@amsterdamumc.nl.
Abstract
BACKGROUND:Elective implant removal (IR) after fracture fixation is one of the most common procedures within (orthopedic) trauma surgery. The rate of surgical site infections (SSIs) in this procedure is quite high, especially below the level of the knee. Antibiotic prophylaxis is not routinely prescribed, even though it has proved to lower SSI rates in other (orthopedic) trauma surgical procedures. The primary objective is to study the effectiveness of a single intravenous dose of 2 g of cefazolin on SSIs after IR following fixation of foot, ankle and/or lower leg fractures. METHODS: This is a multicenter, double-blind placebo controlled trial with a superiority design, including adult patients undergoing elective implant removal after fixation of a fracture of foot, ankle, lower leg or patella. Exclusion criteria are: an active infection, current antibiotic treatment, or a medical condition contraindicating prophylaxis with cefazolin including allergy. Patients are randomized to receive a single preoperative intravenous dose of either 2 g of cefazolin or a placebo (NaCl). The primary analysis will be an intention-to-treat comparison of the proportion of patients with a SSI at 90 days after IR in both groups. DISCUSSION: If 2 g of prophylactic cefazolin proves to be both effective and cost-effective in preventing SSI, this would have implications for current guidelines. Combined with the high infection rate of IR which previous studies have shown, it would be sufficiently substantiated for guidelines to suggest protocolled use of prophylactic antibiotics in IR of foot, ankle, lower leg or patella. Trial registration Nederlands Trial Register (NTR): NL8284, registered on 9th of January 2020, https://www.trialregister.nl/trial/8284.
RCT Entities:
BACKGROUND: Elective implant removal (IR) after fracture fixation is one of the most common procedures within (orthopedic) trauma surgery. The rate of surgical site infections (SSIs) in this procedure is quite high, especially below the level of the knee. Antibiotic prophylaxis is not routinely prescribed, even though it has proved to lower SSI rates in other (orthopedic) trauma surgical procedures. The primary objective is to study the effectiveness of a single intravenous dose of 2 g of cefazolin on SSIs after IR following fixation of foot, ankle and/or lower leg fractures. METHODS: This is a multicenter, double-blind placebo controlled trial with a superiority design, including adult patients undergoing elective implant removal after fixation of a fracture of foot, ankle, lower leg or patella. Exclusion criteria are: an active infection, current antibiotic treatment, or a medical condition contraindicating prophylaxis with cefazolin including allergy. Patients are randomized to receive a single preoperative intravenous dose of either 2 g of cefazolin or a placebo (NaCl). The primary analysis will be an intention-to-treat comparison of the proportion of patients with a SSI at 90 days after IR in both groups. DISCUSSION: If 2 g of prophylactic cefazolin proves to be both effective and cost-effective in preventing SSI, this would have implications for current guidelines. Combined with the high infection rate of IR which previous studies have shown, it would be sufficiently substantiated for guidelines to suggest protocolled use of prophylactic antibiotics in IR of foot, ankle, lower leg or patella. Trial registration Nederlands Trial Register (NTR): NL8284, registered on 9th of January 2020, https://www.trialregister.nl/trial/8284.
Entities:
Keywords:
Ankle; Antibiotic prophylaxis; Cefazolin; Foot; Implant removal; Lower extremity; Orthopedic surgery; Surgical site infections; Trauma surgery
Authors: A Agodi; F Auxilia; M Barchitta; M L Cristina; D D'Alessandro; I Mura; M Nobile; C Pasquarella; Gisio Gisio-SItI Journal: Ann Ig Date: 2017 Sep-Oct
Authors: Fay R K Sanders; Merel F N Birnie; Diederick Penning; J Carel Goslings; Tim Schepers Journal: J Orthop Trauma Date: 2021-04-01 Impact factor: 2.512
Authors: Manouk Backes; Niels W L Schep; Jan S K Luitse; J Carel Goslings; Tim Schepers Journal: Arch Orthop Trauma Surg Date: 2015-04-26 Impact factor: 3.067