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
Recycling of plastics plays an important role to reach a climate neutral industry. To come to a sustainable circular use of materials, it is important that recycled plastics can be used for comparable (or ugraded) applications as their original use. QuinLyte innovated a material that can reach this goal. SmartAgain® is a material that is obtained by recycling of high-barrier multilayer films and which maintains its properties after mechanical recycling. It opens the door for many applications, of which the production of a scoliosis brace is a typical example from the medical field. Scoliosis is a sideways curvature of the spine and wearing an orthopedic brace is the common non-invasive treatment to reduce the likelihood of spinal fusion surgery later. The traditional way to make such brace is inaccurate, messy, time- and money-consuming. Because of its nearly unlimited design freedom, 3D FDM-printing is regarded as the ultimate sustainable technique for producing such brace. From a materials point of view, SmartAgain® has the good fit with the mechanical property requirements of scoliosis braces. However, its fast crystallization rate often plays against the FDM-printing process, for example can cause poor layer-layer adhesion. Only when this problem is solved, a reliable brace which is strong, tough, and light weight could be printed via FDM-printing. Zuyd University of Applied Science has, in close collaboration with Maastricht University, built thorough knowledge on tuning crystallization kinetics with the temperature development during printing, resulting in printed products with improved layer-layer adhesion. Because of this knowledge and experience on developing materials for 3D printing, QuinLyte contacted Zuyd to develop a strategy for printing a wearable scoliosis brace of SmartAgain®. In the future a range of other tailor-made products can be envisioned. Thus, the project is in line with the GoChem-themes: raw materials from recycling, 3D printing and upcycling.
