Post Market Study of Cerament V/G in Pedal Osteomyelitis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMid and South Essex NHS Foundation Trust

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

25 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators