An interventional study of Chlorhexidine gluconate solution and Vancomycin in Post-Op Complication, Spine Surgery and Site Infection, sponsored by Rhode Island Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Rhode Island Hospital · Not applicable, Interventional, and Prevention
Various spine surgeons perform wound irrigation using saline mixed with vancomycin, relying on mechanical debridement of non-viable tissue, physical disruption of biofilm, and bacteriostatic effect against gram positive flora. When used as a powder, topical application of vancomycin has demonstrated increased risk of symptomatic seroma formation, which is an adverse outcome that often requires bedside or intra-operative aspiration. Broad-spectrum antiseptic agents, such as Irrisept, offer bacteriocidal properties to eliminate hardware inoculation, thereby minimizing the risk of deep space infection, while obviating the risk of seroma development.
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.
745 studies on the registry are indexed under Surgical Wound Infection; 151 are open to participants now.
This study's planned enrollment of 200 is close to the median of 200 across 581 interventional studies indexed under Surgical Wound Infection.
Browse Surgical Wound Infection studies →Rhode Island Hospital is the lead sponsor of 191 studies on the registry; 36 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Compared within Surgical Wound Infection, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Postoperative Complications. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients scheduled to undergo spinal instrumentation will receive intra-operative Irrisept irrigation.
Device: Chlorhexidine gluconate solution
Patients scheduled to undergo spinal instrumentation will receive intra-operative irrigation using vancomycin-saline irrigation.
Drug: Vancomycin
Evaluating the prophylactic use of Irrisept irrigation alone
Also known as: Irrisept irrigation
Evaluating the use of versus vancomycin-saline irrigation with or without topical vancomycin
Also known as: Vancomycin-saline
Occurrence of surgical site infection
Development of infection after index spinal instrumentation
Time frame: 90 days post-operatively
Mortality
Capture mortality rates after index spinal instrumentation
Time frame: 12 months post-operatively
Duration of index hospitalization
Capture duration of index hospitalization after index spinal instrumentation
Time frame: 12 months post-operatively
Occurrence of 30-day readmission
Capture 30-day readmission rates after index spinal instrumentation
Time frame: 30 days post-operatively
Occurrence of wound dehiscence
Capture all incidences of wound dehiscence after index spinal instrumentation
Time frame: 12 months post-operatively
Time to closed suction drain removal
Capture the time interval to closed suction drain removal after index spinal instrumentation
Time frame: 12 months post-operatively
Presence of atypical micro-organisms on wound fluid laboratory culture
Capture the presence of atypical micro-organisms after index spinal instrumentation
Time frame: 12 months post-operatively
Cost of spine surgery care from surgery to 12-month post-operative follow up
Consider associated total costs of spinal instrumentation after index spinal instrumentation by comparing total surgical costs and post-surgical outcome expenses of those with and without Irrisept irrigation use
Time frame: 12 months post-operatively
Plan to share: Undecided
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