First-in-man clinical study with Bactiguard coated trauma implants published

24 January 2023

Good outcome for severe open fractures when treated with Bactiguard coated trauma implants, first-in-man study shows

Fracture-related infections are a feared post-operative complication with dire consequences for the patient and high costs for the healthcare systems. It may lead to nail failure, revision surgeries, nail removal and in certain cases, amputation or even death. With the recent study, clinical evidence about Bactiguard’s technology is expanded into the field of orthopaedic surgery where infection prevention is key for patient safety.

In a first-in-man clinical study published late last year in Antibiotics (a specialist journal published online), the use of Bactiguard’s coating technology on orthopaedic trauma implants was evaluated when applied to open fractures. Open fractures are severe cases where the fractured bone protrudes through the skin leading to a wound and therefore an increased infection risk. The study showed an infection rate of 8.6 percent to be compared with literature of similar health-care settings, where the infection rate was between 12.5 percent and 29.1 percent. No side effects were recorded in the study.

“The results confirm the power of Bactiguard’s unique coating, and we are thrilled to expand our clinical evidence into the trauma implant area where we see vast infection prevention needs. Clinical evidence is a key competitive advantage for us, which is why studies of our technology are crucial. They give both healthcare givers and takers concrete evidence that Bactiguard’s coating is efficient. And looking more broadly, less infections lead to less use of antibiotics, making us a force in the combat and protection against antimicrobial resistance,” states Stefan Grass, Chief Medical Officer at Bactiguard.

The hypothesis of the study was that a novel noble metal nail-coating technology could prevent bacterial adhesion and biofilm formation without interfering with bony union. 35 patients were included in the study, and all received Bactiguard coated intramedullary nails. The patients were treated between January 2017 and January 2019 at the Sultanah Aminah Hospital, Johor Bahru, Malaysia.

Three of the 35 patients developed an infection (8.6 percent). All the cases were resolved by antibiotic therapy. Full bone healing was confirmed in 93.8 percent of the patients at the last follow-up. The study concluded that a noble metal alloy-coated titanium nail can prevent infection and facilitate bony union achievement in patients undergoing surgery for severe open fractures (Gustilo type IIIa or IIIb femoral or tibial fractures).

“Being the first-in-man study ever done on this kind of orthopaedic implant makes the findings even more interesting for me and my team of scientists. The infection rate was low, hence less need for antibiotics, and the bony union was high which is an intriguing outcome,” says Dr Thevarajan Karupiah who led the study at Hospital Sultanah Aminah.

Check out the entire study here – it is free to download!

Bactiguard has developed another coated intramedullary orthopaedic nail, like the one used in the Malaysian study, together with its license partner Zimmer Biomet, a leading global medical orthopedy technology company. The so called ZNN Bactiguard trauma nail is currently being launched across the European markets and to collate medical evidence of its efficacy, Zimmer Biomet is performing continuous clinical studies at several leading trauma clinics in Europe. The market for orthopaedic trauma devices is expected to grow exponentially globally, from USD 8.9 billion in 2022 to USD 16.4 billion by 2030, according to a recent report published by market research company GreyViews. Focus now is on the regulatory efforts to obtain approval of the ZNN Bactiguard trauma implants in more key markets, including the US, making them accessible to even more patients across the globe.

The potential is huge – for patients, healthcare budgets and society at large. Just imagine the positive impact using more coated orthopaedic nails would bring to weaker patients. Take the elderly as an example where femoral fractures are common in fall accidents. Getting an infection, in addition to the actual fracture, prolongs rehabilitation and can in some cases even lead to death. Another positive aspect is less days spent in hospitals, which will reduce healthcare costs. In short, a win-win concept, concludes Stefan Grass.

The study at a glance:

  • 35 patients
  • 8.6% infection rate (comparable data between 12.5% and 29.1%)
  • 93.8% full bone healing