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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Cerament V or G implantation into forefoot or mid foot bone, and 7-10 days of oral antibiotics.
Freedom from clinical or radiological osteomyelitis in the same or adjacent bone (recorded as yes or no)
Clinical osteomyelitis: positive bone biopsy in the setting of bone necrosis or purulent fluid containing pathogenic organisms emanating from exposed bone end. Radiological osteomyelitis: osteolysis or periosteal reaction on radiograph in affected or adjacent bone(s). This is checked at each follow up visit, at 1, 6 and 12 months post-implantation.
Time frame: 12 months post-implantion
Surgical site infection requiring further course of antibiotics (recorded as yes or no)
If there is infection at the surgical site, requiring a further course of antibiotics, this will be recorded.
Time frame: 12 months post-implantion
Major or minor amputation of study limb (recorded as yes or no with amputation details)
If major or minor amputation of study limb occurs, this will be recorded.
Time frame: 12 months post-implantion
Serious adverse events related to Cerament V/G (number and type of event are recorded)
A serious adverse event (SAE) refers to any expected or unexpected adverse event, related to ceramist, that results in any of the following outcomes: death, a life-threatening adverse event, requires inpatient hospitalisation (not required as part of the treatment) or prolongation of existing hospitalisation, a persistent or significant disability or incapacity, or cancer, or a congenital anomaly or birth defect.
Time frame: 12 months post implantation
Total treatment costs for osteomyelitis (total cost is calculated in GB pounds)
Treatment costs will be collected through the use of a Client Service Research Inventory focussed on surgical, community and further treatment costs over a 12 month follow up. These will be recorded by the patient as they occur and checked at each visit and cross reference with hospital medical records.
Time frame: 12 months post-implantation
Wound healing (recorded as yes or no)
Wound is considered healed at 100% epithelialisation. This is checked at each follow up visit, at 1, 6 and 12 months post-implantation.
Time frame: 12 months post-implantation
Wound area (measured in cm^2)
Wound area is measured at each follow up visit, at 1,6 and 12 months post-implantation, using an app called Imito measure.
Time frame: 12 months post-implantation
Quality of life (measured using the EQ-5D questionnaire)
Quality of life is measured using the EQ-5D questionnaire. It is conducted at each follow up visit, at 1, 6 and 12 months post-implantation.
Time frame: 12 months post-implantation
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