Post-surgical spinal infection occurs in up to 20% of patients, despite aggressive peri-operative antibiotic treatments. To improve prophylaxis, we have designed and evaluated an ultrasound-activated prophylactic antibiotic release system to combat post-surgical bacterial survival. Polylactic acid (PLA) clips (1 cm) were 3D-printed with an interior reservoir (0.8 cm) for carrying drug payload, specifically vancomycin (VAN). Under IACUC approval, clips were surgically implanted into the spines of sheep (n = 9) and swine (n = 2) by removing the spinous process at several levels of the lumbar spine. In the sheep, clips were insonated and the interstitial wound fluid was collected to quantify the ultrasound-triggered VAN release. Uninsonated control sheep exhibited an average VAN concentration of 6.32 ± 5.99 µg/mL after 72 h, while ultrasound-triggered clips released significantly higher VAN concentrations at 72 h (22.98 ± 11.22 µg/mL, p = 0.033). In the swine, device efficacy against Staphylococcus aureus was evaluated. Insonated sites saw significant reduction in colony forming units (CFU) to 4.3 ± 3.2 CFU in the activated clips, compared to uninsonated controls where bacterial colonization was higher (2898 ± 1214 CFU, p = 0.017). Overall, these results demonstrate the ability to non-invasively release VAN from an implanted reservoir in vivo, and that this VAN release is effective in mitigating invading microbes in the wound site.

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http://dx.doi.org/10.1016/j.ijpharm.2025.125276DOI Listing

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