Post Market Study of Cerament V/G in Pedal Osteomyelitis (Cerament 2)

Mid and South Essex NHS Foundation Trust

Status: Not yet enrolling

Conditions: Osteomyelitis - Foot

Treatments: Device: cerament V or G

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06628115

339714

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Cerament

Experimental group

Description:

Cerament V/G implantation to forefoot or mid foot.

Treatment:

Device: cerament V or G