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

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.

• Authors: Lorenzo Drago, Delia Romanò, Elena De Vecchi, Christian Vassena, Nicola Logoluso, Roberto Mattina, Carlo Luca Romanò
• Journal: BMC infectious diseases (BMC Infect Dis) Vol. 13 Pg. 584 (Dec 10 2013) ISSN: 1471-2334 [Electronic] England
• PMID: 24325278 (Publication Type: Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Bone Substitutes
• bioactive glass S53P4

Topics

• Acinetobacter baumannii (growth & development)
• Adult
• Aged
• Aged, 80 and over
• Bone Substitutes (chemistry, therapeutic use)
• Bone and Bones (microbiology)
• Female
• Glass (chemistry)
• Humans
• Male
• Methicillin-Resistant Staphylococcus aureus (growth & development)
• Middle Aged
• Osteomyelitis (microbiology, surgery)
• Prospective Studies
• Pseudomonas aeruginosa (growth & development)
• Staphylococcus epidermidis (growth & development)
• Young Adult