When do you throw in the towel and remove the spinal implant?
Researchers under the direction of Aakash Agarwal, Ph.D., of the University of Toledo, tackled this immensely difficult subject in a recently published review in the Global Spine Journal.
Dr. Agarwal and his team reviewed 49 studies pertaining to the management of late onset surgical site infections (SSI) after spinal surgery.
The authors concluded that although long-term antibiotics, debridement, and continuous irrigation are the most common treatments for late onset SSI, the most statistically effective measure for reducing risk is implant removal or replacement.
Specifically, Agarwal and his team wrote that bacteria may lay dormant in the body for long periods and that bacteria-free implants are critical for biofilm prevention and therefore prevention of late onset surgical site infection (SSI.)
The other key question raised by the team is: Should American hospitals radically change their implant processing protocols?
First: What is the True Infection Rate?
Agarwal explained the impetus for the study to OTW, saying that “despite clinical data against reprocessing of implants, manufacturers are supplying these implants with impractical steps of cleaning.” According to Agarwal, these steps are not followed by hospitals and would not sufficiently clean the implant even if these protocols were followed. As a result, Agarwal stated, “every single patient is exposed to a risk of cross contamination and [the] FDA [has been] fully aware of it since October 2018.”
Agarwal told OTW, “we have multi-center level 2 clinical evidence that any touch or exposure of implants in the ‘sterile’ field results in bacterial biodose being accumulated onto these devices. These devices are then implanted deep in the bone. So, to appreciate the consequences of this egregious practice ongoing in the field of spine surgery, my interest in this review was to find out the discrepancy in reporting SSI in terms of average duration and management.”
The authors conducted a PubMed search of prospective and retrospective articles published between 2000 and 2018 relating to the characterization of SSIs after spinal surgeries. They conducted title and abstract reviews followed by full-text review of all references that appeared to address SSI infection management.
At the end of the process, the team had culled 49 articles culled out of 79 retrieved from PubMed. The team established relevancy based on the following criteria: implant removal rate, common organisms related to infection, infection onset time, or the ratio of superficial to deep infection.
The study authors, in addition to Aakash Agarwal, were: Amey Kelkar, M.S., Ashish G. Agarwal, M.B.B.S., Daksh Jayaswal, M.S., Christian Schultz, M.D., Arvind Jayaswal, M.D., Vijay K. Goel, Ph.D., Anand K. Agarwal, M.D., Sandeep Gidvani, M.D.
