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Post Market Study of Cerament V/G in Pedal Osteomyelitis

CompletedNA

Sponsor: Mid and South Essex NHS Foundation Trust

Conditions: Osteomyelitis - Foot

Interventions: cerament V or G

Countries: United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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;amp \&lt;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) \&amp;gt; 30ml/min/1.72m2

Locations (1)

Basildon, Essex, United Kingdom