Post Market Study of Cerament V/G in Pedal Osteomyelitis

Post-market Study of Cerament V/G in Foot Osteomyelitis

The goal of this clinical trial is to look at the outcomes of patients who have had bone infection of their feet treated with a licensed antibiotic paste. The main question it aims to answer is:

• How does the bone infection heal in response to the antibiotic paste?

Participants will:

• Undergo standard surgery to remove dead bone and drain any pus.
• Antibiotic paste is injected directly into the middle of the bone at surgery. This is instead of receiving antibiotics directly into their bloodstream for 6 weeks.
• Recieve one week of tablet antibiotics.
• Visit clinic 1 month after surgery for a normal clinical appointment. After, a research team member will ask the participant a few questions. The participant will also have a foot x-ray, wound photograph and fill out a short questionnaire.
• Visit clinic 6 months and 12 months following the surgery. A research team member will ask the participant a few questions. The participant will also have a foot x-ray, wound photograph and fill out a short questionnaire.

Inclusion Criteria:

• 18 years +
• Informed consent
• Operated on for foot sepsis with limb salvage intent.
• Positive bone biopsy from forefoot or midfoot or positive pus culture from exposed bone
• Adequate vascularity (1+ palpable pedal pulse, biphasic or triphasic ankle waveforms, or successful revascularisation procedure same admission)
• Compliant with offloading footwear and diabetic medication

Exclusion Criteria:

• Allergy or contraindication to gentamicin/vancomycin
• Life expectancy &amp <1 year
• Unable to make follow up appointments at study centre.
• Patients with necrotizing infections
• Gentamicin or vancomycin resistant organism
• Untreated peripheral arterial disease in angiosome of wound.
• Buerger's disease
• Vasculitides
• Systemic immunosuppressive therapy
• Pregnancy
• Breastfeeding
• Untreated thyrotoxicosis
• Mysathenia gravis
• Calcium metabolism disorder
• Patients taking metformin with estimated glomerular filtration rate (eGFR) > 30ml/min/1.72m2