For the first time in the world, a ceramic implant containing an antibiotic has been implanted in a patient with a chronic infection. The operation took place in Limoges.
It is a world first. A ceramic implant of the company I.CERAM containing an antibiotic was implanted in a patient with mediastinitis. And cocorico, this operation was carried out in France. More exactly in June 2016 at the Limoges University Hospital by Dr François Bertin.
In a press release, we learn that the patient, 68 years old, diabetic and suffering from chronic bronchitis, developed mediastinitis (infection of the mediastinum, anatomical area behind the sternum) following a quadruple coronary bypass surgery. He then underwent several surgeries and was hospitalized at the Limoges University Hospital for more than 10 months. Complications brought him to intensive care on several occasions, including septic shock and a heart rhythm disorder which required the placement of a pacemaker.
A patient with a chronic infection
Her breastbone, which had been cut in half for the first operation, had never healed from the infection. The patient presented with respiratory complications and a gaping wound in the thorax.
Faced with the complexity of this case, the existing treatments presented too great an infectious risk to intervene: “In view of the great fragility of the patient, the cement modeling or the metal prostheses presented too great infectious risks. With this intervention, it gave me additional security in relation to the infectious risk of this last surgery, ”says Dr François Bertin from the Cardiac, Thoracic and Vascular Surgery department.
This is why the placement of a ceramic implant loaded with gentamicin was then accepted by the National Medicines Safety Agency (ANSM). “The porosity of the ceramic allowed local release of gentamicin at the time of implantation. And this release led to the destruction of bacteria sensitive to the antibiotic which had infected the surgical site, ”describes the doctor.
A success for the patient
The patient left the Limoges University Hospital only 20 days after the operation, a sign of good postoperative recovery. In addition, the patient’s wound was healed by the 3rd week and there was no postoperative infectious complication.
To date, and with four months of clinical experience, here is Dr Bertin’s assessment: “The operation was a success. The patient even regained his initial respiratory capacities and his functional autonomy ”, he specifies on the website of the company I.CERAM.
The next steps targeted are obtaining the CE marking for the unloaded sternal implant during the first quarter of 2017 and the start of a multicenter study aimed at evaluating the survival of patients with mediastinitis, treated by the implantation of mediastinitis. ‘a bioceramic sternum loaded with gentamicin in mid-2017.
An economic gain for the public health system
According to public economic data, one day in surgery costs 1,700 € (1) and one day in intensive care costs 3,190 € (1). Hospitalization of the patient, before the operation in June 2016, can be estimated at € 550,000 (1). Reducing hospitalization time by using a loaded ceramic implant is therefore a real medical and financial gain.
This especially since mediastinitis occurs in 2% to 3% of cardiac surgery interventions. The increasing number of cardiac operations is therefore leading to an increase in the number of infectious complications.
(1) Data from the Center Hospitalier de Sens – Hôpital de Sens
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