Investigating the efficacy of antibiotic beads in foot infections v1
Research type
Research Study
Full title
How effective are various combinations of antibiotic-loaded beads at eradicating polymicrobial infections in a clinically reflective model of infected foot wounds?
IRAS ID
275862
Contact name
Rahaf Issa
Contact email
Sponsor organisation
The University of Manchester
Duration of Study in the UK
0 years, 10 months, 30 days
Research summary
Chronic infected foot wounds place a major burden on healthcare systems worldwide. Procedures for treatment usually involve a course of oral or systemic antibiotics as outlined by local prescribing guidelines. However, the likelihood of such treatments eradicating an infection is low. In addition, some diseases reduce blood flow to extremities, and thus the site of infection, impairing the delivery of systemic antibiotics. Novel vehicles for effective topical antibiotic delivery are therefore required to maintain sufficient antibiotic levels and elicit an effective treatment. Stimulan, an absorbable calcium sulphate which can be formulated into antibiotic-loaded beads, is an example of such vehicles.
This study is funded by Biocomposites Ltd and will utilise Stimulan beads loaded with various antibiotic combinations to determine their efficiency in a laboratory model simulating a non-healing infected wound, with clinically reflective levels of exudate. The study will therefore collect tissue from patients who present with an infected foot lesion at Manchester University NHS Foundation Trust, that is debrided during standard treatment procedures at the first visit. Debrided tissue will be processed in three ways by the research team: (1) microorganisms will be harvested and identified using standard microbiology techniques, and used to create an infected laboratory wound model, (2) a portion of the tissue will be analysed using standard histology techniques to visualise the structure of the tissue, and (3) white blood cells will be isolated from the tissue to study the extent of local inflammation. A blood sample will also be obtained to study systemic inflammation. Patients who have/have not received antibiotic treatment will be eligible. The study will recruit twenty patients, who are required to attend one clinic visit. The research data collected will provide valuable information on the efficiency of antibiotic-loaded Stimulan beads against bacteria harvested from chronic wounds, and the extent of systemic/local inflammation.
REC name
North West - Haydock Research Ethics Committee
REC reference
20/NW/0265
Date of REC Opinion
28 May 2020
REC opinion
Favourable Opinion