Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06439953
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-28
Brief Title:
Impact of Prophylactic Use of Irrisept Irrigation System for Spinal Instrumentation
Sponsor:
Jared Fridley
Organization:
Lifespan
Study Overview
Official Title:
Impact of Prophylactic Use of Irrisept Irrigation System for Spinal Instrumentation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 005 chlorhexidine gluconate in 9995 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 andor sacral spinal instrumentation for various indications deformity malignancy degenerative pathology and trauma at Rhode Island Hospital
Irrisept Irrimax Corporation Gainesville Florida is a solution comprised of 005 chlorhexidine gluconate in 9995 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 andor sacral spinal instrumentation for various indications deformity malignancy degenerative pathology and trauma at Rhode Island Hospital
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None