Spinal instrumentation remains the standard of care in the treatment of various
traumatic, oncologic, and degenerative spinal pathologies, often requiring the
implantation of hardware to stabilize the bony column. In the setting of an aging patient
population and expanding indications for instrumentation in younger patients, the number
of spinal operations performed has risen substantially within the past decade. Although
these procedures have proven to enhance patient quality of life, spinal instrumentation
is not without post-operative complication, most notable of which are surgical site
infection, seroma formation, and wound breakdown. Such complications can result in
notable negative sequelae. Recurrent seroma may compress underlying neurologic structures
or increase pressure along the incision, thereby precipitating wound dehiscence and
inoculation of the surgical site with pathogenic organisms. Deep space infections often
result in prolonged hospitalization, long-term suppressive antibiotic therapy, hardware
removal, and permanent disability, which increases cost burden at the patient and
hospital level. As such, preventative strategies to reduce the rate of complications
following spinal instrumentation remain paramount. Within recent years, attention has
turned to various irrigation methods to terminally sterilize prosthetic devices and wound
beds, thereby minimizing bacterial colonization and biofilm formation that would
otherwise predispose infection.
Irrisept (Irrimax Corporation, Gainesville, Florida) is a solution comprised of 0.05%
chlorhexidine gluconate in 99.95% sterile water administered through a proprietary,
low-pressure lavage mechanism that has demonstrated efficacy as a bacteriocidal agent in
orthopedic hip and knee arthroplasty procedures. Whereas other antiseptic irrigation
solutions, such as vancomycin-saline lavage, are routinely used to prevent surgical site
infection, relative inertness against gram negative organisms and potential
predisposition toward seroma formation render them non-ideal for use in spine surgery.
Despite the utility of dilute chlorhexidine gluconate as a prophylactic irrigant, there
exist gaps in knowledge with regard to the efficacy of Irrisept to prevent post-operative
complications following spinal instrumentation. The central hypothesis of this proposal
is that prophylactic use of Irrisept irrigation will result in fewer surgical site
infections, clinically significant seromas, and gram negative or atypical infections when
compared to standard of care irrigation (vancomycin-saline solution with or without
topical vancomycin powder).
Proposed is a prospective, randomized controlled trial comparing rates of post-operative
complications following use of Irrisept irrigation alone versus vancomycin-saline lavage
with or without topical vancomycin powder (standard of care) in patients aged 18 years or
older who undergo posterior cervical, thoracic, lumbar, and/or sacral spinal
instrumentation for various indications (deformity, malignancy, degenerative pathology,
and trauma) at Rhode Island Hospital.