Osteomyelitis - Foot
Conditions
Keywords
osteomyelitis, antimicrobial, bone void filler, cerament
Brief summary
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.
Interventions
DEVICEcerament V or G
Cerament V or G implantation into forefoot or mid foot bone, and 7-10 days of oral antibiotics.
Sponsors
Mid and South Essex NHS Foundation Trust
BONESUPPORT AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Case Series
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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) \&gt; 30ml/min/1.72m2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from clinical or radiological osteomyelitis in the same or adjacent bone (recorded as yes or no) | 12 months post-implantion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical site infection requiring further course of antibiotics (recorded as yes or no) | 12 months post-implantion | If there is infection at the surgical site, requiring a further course of antibiotics, this will be recorded. |
| Major or minor amputation of study limb (recorded as yes or no with amputation details) | 12 months post-implantion | If major or minor amputation of study limb occurs, this will be recorded. |
| Serious adverse events related to Cerament V/G (number and type of event are recorded) | 12 months post implantation | 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. |
| Total treatment costs for osteomyelitis (total cost is calculated in GB pounds) | 12 months post-implantation | 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. |
| Wound healing (recorded as yes or no) | 12 months post-implantation | Wound is considered healed at 100% epithelialisation. This is checked at each follow up visit, at 1, 6 and 12 months post-implantation. |
| Wound area (measured in cm^2) | 12 months post-implantation | Wound area is measured at each follow up visit, at 1,6 and 12 months post-implantation, using an app called Imito measure. |
| Quality of life (measured using the EQ-5D questionnaire) | 12 months post-implantation | 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. |
Countries
United Kingdom
Contacts
PRINCIPAL_INVESTIGATORAnkur Thapar
Mid and South Essex NHS Foundation Trust
Outcome results
None listed