Post-market Study of Cerament V/G in Foot Osteomyelitis

Mid and South Essex NHS Foundation Trust0 sites25 target enrollmentOctober 1, 2024

ConditionsOsteomyelitis - Foot

Overview

Phase: N/A
Intervention: Not specified
Conditions: Osteomyelitis - Foot
Sponsor: Mid and South Essex NHS Foundation Trust
Enrollment: 25
Primary Endpoint: Freedom from clinical or radiological osteomyelitis in the same or adjacent bone (recorded as yes or no)
Status: Not Yet Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 1, 2024

End Date

November 1, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Mid and South Essex NHS Foundation Trust

Responsible Party

Sponsor

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 \<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

Outcomes

Primary Outcomes

Freedom from clinical or radiological osteomyelitis in the same or adjacent bone (recorded as yes or no)

Time Frame: 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 Outcomes

Surgical site infection requiring further course of antibiotics (recorded as yes or no)(12 months post-implantion)
Major or minor amputation of study limb (recorded as yes or no with amputation details)(12 months post-implantion)
Serious adverse events related to Cerament V/G (number and type of event are recorded)(12 months post implantation)
Total treatment costs for osteomyelitis (total cost is calculated in GB pounds)(12 months post-implantation)
Wound healing (recorded as yes or no)(12 months post-implantation)
Wound area (measured in cm^2)(12 months post-implantation)
Quality of life (measured using the EQ-5D questionnaire)(12 months post-implantation)