Canadian life sciences company, Ondine Biomedical Inc. (OBI: LON), reports that an independent, peer-reviewed research paper, “Effectiveness of prophylactic intranasal photodynamic disinfection therapy and chlorhexidine gluconate body wipes for surgical site infection prophylaxis in adult spine surgery” from Vancouver General Hospital (“VGH”) has been published in the Canadian Journal of Surgery. The study spanned an eight-year period and involved 13,493 patients with 8823 patients receiving Steriwave®. The paper concludes that nasal photodisinfection should be the standard of care for all patients undergoing emergent or elective spine surgeries.

The eight-year study showed a 66.5% reduction (7.98% vs 2.67%, p<0.001) in surgical site infections (SSIs) following spine surgery when Ondine’s Steriwave nasal photodisinfection (nPDT) was implemented in the universal pre-surgical infection prevention protocol. The study also found that the hospital saved $19.9 million net over the study period (2011 to 2019), an average net annual cost saving of $2.49 million.

The research was conducted by the Vancouver General Hospital spine group, led by Professor John Street.  Professor Street is the Director of the Integrated Ambulatory Spine program at VGH, one of Canada’s largest referral centres for complex spinal trauma and spine disorder cases. Professor Street is the creator of the SAVES quality improvement programme (Spine Adverse Events System). The SAVES programme has more than 100 peer-reviewed publications and has received numerous national and international awards.

The study’s authors concluded that:

“Preoperative bundled nPDT–CHG is a clinically effective strategy for reducing the incidence of SSIs after emergent or elective spine surgery. It is an affordable intervention and is associated with significant institutional savings for every SSI prevented in this high-risk population. Given its rapid action, minimal risk of antimicrobial resistance, broad-spectrum activity, and high compliance rate, preoperative bundled nPDT–CHG decolonization should be the standard of care for all patients undergoing emergent or elective spine surgery.”

Ondine Biomedical CEO Carolyn Cross said:

“With this simple, 5-minute, painless intervention our Steriwave treatment makes a life-saving impact – in this case, 468 spine surgery patients saved from potentially lethal infections – more than enough to fill a 747 plane. We are truly grateful to Professor Street and the research staff at VGH for their pursuit of better patient outcomes. Postoperative spine infection can be a devastating and expensive complication after spine surgery, with patients at high risk for chronic pain, paralysis, return to the operating room, poor long-term outcomes, and even death. This study conclusively demonstrates that Steriwave is setting a new standard for safety and performance in infection control.”

Surgical site infections are serious complications that can occur following surgery, and SSIs following spine surgery can affect up to 18% of patients who may then require long, complex and costly treatment.[i] Nasal decolonization is now deemed an essential practice prior to major surgeries, including spine and cardiac surgery, by the Society for Healthcare Epidemiology of America (SHEA).[ii] However, the topical antibiotic typically used for nasal decolonization before surgery, mupirocin, has shown antimicrobial resistance rates as high as 81%.[iii] SSIs involving drug-resistant pathogens are associated with significantly increased length of hospitalization and costs.[iv]

[i] Chahoud J, Kanafani Z, Kanj SS. Surgical site infections following spine surgery: eliminating the controversies in the diagnosis. Front Med (Lausanne). 2014 Mar 24;1:7. doi: 10.3389/fmed.2014.00007.

[ii] Calderwood MS, Anderson DJ, Bratzler DW, et al. Strategies to prevent surgical site infections in acute-care hospitals: 2022 Update. Infect Control Hosp Epidemiol. 2023;44(5):695-720. doi:10.1017/ice.2023.67

[iii] Poovelikunnel T, Gethin G, Humphreys H. Mupirocin resistance: clinical implications and potential alternatives for the eradication of MRSA. J Antimicrob Chemother. 2015;70(10):2681-2692. doi:10.1093/jac/dkv169

[iv] Weigelt JA, Lipsky BA, Tabak YP, Derby KG, Kim M, Gupta V (2010) Surgical site infections: causative pathogens and associated outcomes. Am J Infect Control 38:112–120. https://doi.org/10.1016/j.ajic.2009.06.010