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

Abstract

BackgroundThis 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.MethodsIn 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.ResultsIn 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.ConclusionsThe 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 registrationDeutschen Register Klinischer Studien (DRKS) unique identifier: DRKS00005332.

Influence of bioactive glass S53P4 granules and putty on osteomyelitis associated bacteria in vitro

“…All granule sizes of BAG S53P4 glass provided bacterial inhibition at the end of the study period. This is in accordance with the in-vitro bactericidal capacity recently observed for BAG S53P4 of 500-800 µm size on S. aureus and epidermidis, P. aeruginosa and Acinetobacter baumannii by Drago and co-workers [21], as well as for powder and granules of 2.0-3.0 mm size on S. aureus, S. epidermidis, E. coli and K. pneumoniae [7]. Earlier findings on the efficacy of BAG S53P4 powder to prevent bacterial growth in-vitro were also confirmed in this study; the powder was the most effective material against all the pathogens tested [10,18,19,26].…”

“…In addition to its osteoconductive and osteostimulative properties, BAG S53P4 has also shown excellent antibacterial properties on both aerobic and anaerobic species invitro [16][17][18][19][20][21][22]. BAG S53P4 is also the first known biomaterial that has been shown to decrease biofilm burden, is effective towards multi-resistant "super bugs" and does not induce resistance in bacteria [23][24][25].…”

“…BAG S53P4 has been studied clinically in randomised prospective trials in bone tumour [27,28], trauma [29] and spine surgery [30,31]. Due to its antibacterial properties is has also been used in the treatment of severe chronic osteomyelitis, mastoiditis, spine infections and frontal sinus infections [21,[32][33][34][35][36][37][38].…”

A chlorhexidine-releasing epoxy-based coating on titanium implants prevents Staphylococcus aureus experimental biomaterial-associated infection

“…The effectiveness and widespread use of chlorhexidine has led to some concerns regarding the emergence of bacterial resistance (Edmiston et al, 2013;Horner et al, 2012), including MRSA resistance (Johnson et al, 2015). However, reported levels of susceptibility of the bacterial isolates are still several orders of magnitude below the clinically applied dosages (Horner et al, 2012).…”

“…These coatings are particularly suited for non-cemented implants, which in contrast to cemented implants cannot be protected by e.g. antibiotic releasing bone cement (Lynch et al, 1987;Nijhof et al, 2000) or other antimicrobial approaches, such as the use of bioactive glass (Drago et al, 2013;Romano et al, 2014), and are more prone to recurrent infection (Dale et al, 2009;Neut et al, 2015).…”