Antimicrobial Synthetic Bone Grafts
Condition: Bone Infection; Bone Graft Infection
MeSH terms: Infections; Communicable Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This project aims to produce synthetic bone tissue graft that supports bone regeneration and
      combats infection simultaneously, according to industry standards and regulations. This
      original and high value added biomaterial "silver doped calcium phosphate based synthetic
      bone tissue " will be used in clinical trials in patients with osteomyelitis and
      implant-related infections for the treatment.

      Chronic bone infections are one of the most important problems in orthopedic surgery and are
      not just a problem of developed societies. When open fracture cases, which may get infected
      in 1-50%, implant-related infections and diabetic foot ulcer cases are taken into
      consideration, osteomyelitis will be seen as a very common problem all over the world.
      Multiple surgeries, long-term use of antibiotics and the high costs affects all societies.
      The use of synthetic bone grafts is growing faster than the natural bone grafts in the world.
      USA has spent 246 million US dollars for the use of synthetic bone graft in 2010. For the
      treatment of bone infections antibiotic impregnated synthetic bone grafts with different
      characteristics are used. Although these antibiotic impregnated synthetic bone grafts are
      superior compared to antibiotic bone cement with the implementation of different antibiotics
      and to be absorbable but they cannot show optimum benefit because the release of antibiotics
      is not due to host matrix degradation but diffusion control. The other issue to be considered
      as this regard that the development of microbial resistance to these antibiotics which is
      also a serious problem. Innovative synthetic bone graft with better contribution of the needs
      of mechanical properties, depending on the applied bone region, optimized antimicrobial
      activity and bone tissue regeneration are needed.

      In this study, it will be determined whether this silver ion -doped antimicrobial synthetic
      bone graft that has the capacity to fill the bone voids that may occur in chronic bone
      infection during disease process or after surgical debridement, also has the capacity to
      treat the infection in the bone will be used in 12 patients who had been diagnosed as chronic
      osteomyelitis to see if it cause any unwanted side effect in normal usage conditions and
      generates unacceptable risks. Clinical, laboratory and radiological investigations will be
      used to demonstrate the healing of the infections and the cavities in the bone. Blood and
      urine levels of silver will be detected from patients.

      Antimicrobial activity of silver is well-known. The effectiveness of the silver and potential
      toxicity is related to the dose of silver and application form. In orthopedics, the use of
      silver is mostly limited to elemental silver coating of metal implants. There is no
      biotechnologic approach manufactured silver ion -doped calcium phosphate -based synthetic
      bone graft in the health sector yet. Ionic silver has advantages such as low toxicity, no
      tolerance of silver against bacteria, and strong antibacterial activity. The trapping of
      silver ions in the calcium phosphate based ceramic structure overcomes the other systems with
      its controlled release and its ability to be effective at minimum doses. The project is an
      original work since it will contribute to bone regeneration while at the same time removing
      the infection.
    


Intervention name(s): antimicrobial synthetic bone graft; parentaral antimicrobials and pure bone grafts
Intervention type(s): Device; Device
Intervention description(s): It will be determined whether the silver ion-doped antimicrobial synthetic bone graft that has the capacity to fill the bone voids also has the capacity to treat the infection in the bone in 12 patients with chronic osteomyelitis; Historical data of the department will be used for comparison of the results
Intervention MeSH terms: Anti-Infective Agents; Anti-Bacterial Agents
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: experimental group will be compared with parental antibiotics group
Masking: None (Open Label)
Primary purpose: Treatment