Open Access Research article

Bioactive glass BAG-S53P4 for the adjunctive treatment of chronic osteomyelitis of the long bones: an in vitro and prospective clinical study

Lorenzo Drago12*, Delia Romanò3, Elena De Vecchi1, Christian Vassena1, Nicola Logoluso3, Roberto Mattina4 and Carlo Luca Romanò3

Author Affiliations

1 Laboratory of Clinical Chemistry and Microbiology, I.R.C.C.S. Galeazzi Orthopaedic Institute, Via R. Galeazzi 4, Milan 20161, Italy

2 Department of Biomedical Sciences for Health, University of Milan, Via Mangiagalli 31, 20161, Milan, Italy

3 Department of Reconstructive Surgery of Osteo-articular Infections C.R.I.O. Unit, I.R.C.C.S. Galeazzi Orthopaedic Institute, Milan 20161, Italy

4 Department of Biomedical, Surgical and Odontoiatric Sciences, University of Milan, Via della Commenda 10, 20122, Milan, Italy

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BMC Infectious Diseases 2013, 13:584  doi:10.1186/1471-2334-13-584

Published: 10 December 2013

Abstract

Background

This study aimed to explore the in vitro antibacterial activity of the bioglass BAG S53P4 against multi-resistant microorganisms commonly involved in osteomyelitis and to evaluate its use in surgical adjunctive treatment of osteomyelitis.

Methods

In vitro antibacterial activity of BAG-S53P4 against methicillin resistant Staphylococcus aureus and Staphylococcus epidermidis, Pseudomonas aeruginosa and Acinetobacter baumannii isolates was evaluated by means of time kill curves, with colony counts performed after 24, 48 and 72 hours of incubation. In vivo evaluation was performed by prospectively studying a cohort of 27 patients with a clinically and radiologically diagnosed osteomyelitis of the long bones in an observational study. Endpoints were the absence of infection recurrence/persistence at follow-up, no need for further surgery whenever during follow-up and absence of local or systemic side effects connected with the BAG use.

Results

In vitro tests regarding the antibacterial activity of BAG S53P4 showed a marked bactericidal activity after 24 hrs against all the tested species. This activity continued in the subsequent 24 hrs and no growth was observed for all strains after 72 hrs. Results of the clinical study evidenced no signs of infection in 24 patients (88.9%) at the follow-up, while 2 subjects showed infection recurrence at 6 months from index operation and one more needed further surgical procedures. BAG-S53P4 was generally well tolerated.

Conclusions

The in vitro and in vivo findings reinforce previous observations on the efficacy of BAG-S53P4 for the treatment of chronic osteomyelitis of the long bones, also in the presence of multi-resistant strains and in immunocompromised hosts, without relevant side effects and without the need for locally adding antibiotics.

Trial registration

Deutschen Register Klinischer Studien (DRKS) unique identifier: DRKS00005332.

Keywords:
Bone infections; Staphylococcus aureus; Pseudomonas aeruginosa; Bioactive glass