About this trial
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 criteria
Qualifiers
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
Disqualifiers
Allergy or contraindication to gentamicin/vancomycin
Life expectancy &amp <1 year
Unable to make follow up appointments at study centre.
Patients with necrotizing infections
Trial design
Treatments tested in this trial
- cerament V or G
Treatment groups
Locations
Sponsors and collaborators
Mid and South Essex NHS Foundation Trust
Lead sponsor
BONESUPPORT AB
Collaborator