One of the demonstration pilots within the BFCC project concerns the research area of infections after fractures. The hypothesis of the pilot study is that the local concentration of vancomycin will reach bactericidal level, while the systemic concentration will be below toxic levels by the use of bone substitute CERAMENT™|V containing vancomycin in patients with a trochanteric hip fractures undergoing osteosynthesis with a dynamic hip screw (DHS).
For included patients the fracture will be repositioned and closed under the control of an amplifier. The surgical preparation of the DHS insertion will be prepared in accordance to the manufacturer’s instruction and department routines. The femur neck drill hole and the fracture site will be filled with CERAMENT™|V in the liquid phase just after tapping and before the insertion of the dynamic screw.
For the assessment of the concentration of vancomycin, wound drain fluids will be sampled within 6, 12, 18, 24, 30, 36, 42 and 48 hours postoperatively as long as the drain fluid pouch is used. Additionally, the urine of the patients and the blood serum will be sampled daily during the hospital stay (seven days) for the assessment of the daily urine volume and concentration of vancomycin in both fluids.
“We expect our study to show that vancomycin from CERAMENT™|V elutes in high burst rates during the first hours after the operation. The local level of the concentration will be sufficient not only to prevent an infection, but also to eradicate it after a bone or joint sepsis,” explains pilot leader Šarūnas Tarasevičius, from the Lithuania University of Health Science.
To test the BFCC platform for its performance regarding industry-hospital cooperation, three demonstration pilots will be carried out within the research areas of I) Infections after fractures, II) bone density measurement after fractures and III) complication management after fracture treatment.