- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02631408
Intrawound Vancomycin Powder in Spinal Fusion Surgery (iVRCT)
Application of Intrawound Vancomycin Powder to Reduce Surgical Site Infections in Spinal Fusion Surgery - A Prospective, Randomized, Controlled Trial
Vancomycin powder (for solution for Infusion) will be investigated (off-label usage) in spinal fusion surgery. The powder will be locally administered into to the wound cavity before wound closure.
Hypothesis: Locally applied vancomycin powder leads to a reduction in postoperative surgical site infections
Study Overview
Detailed Description
Vancomycin is being widely used as an antibiotic agent for intravenous and topical use. The surgical application of vancomycin powder in Austria is limited as there is no powder with marketing authorization for intraoperative, intrawound usage. Previous reports widely document the application of vancomycin powder for solution for infusion. The powder is not soluted, but instead directly spread throughout the wound surface. Limited data is available for spinal fusion surgery, mostly retrospective studies. Results were promising, but the low evidence level does not allow for a conclusion regarding routine usage. Additional randomized, controlled trials are necessary to further investigate this matter.
This trial aims to investigate Vancomycin powder "Xellia" 1000mg, which has a Marketing authorization, in an off-label usage (intrawound, intraoperatively) in spinal fusion surgery. The investigational medicinal product will be used unmodified.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Vienna, Austria, 1130
- Orhopedic Hospital Speising
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Planned TLIF (transforaminal lumbar interbody fusion) or PLIF (posterolateral lumbar interbody fusion) surgery
- TLIF/PLIF fusion length of one or two motion-segments OR
- One motion-segment TLIF/PLIF in conjunction with one motion-segment decompression surgery or microscopic disc surgery (microdiscectomy)
- Fusions within L1 (first lumbar vertebra) through S1 (sacrum)
- Age of 18-years or older
- Signed informed consent
Exclusion Criteria:
- Preoperative inflammatory or infectious state (C-reactive protein levels above 10mg/l)
- Allergic to vancomycin, teicoplanin or penicillin
- Preexisting auto-immune disease with an impaired immune system
- Current post-traumatic vertebral injury (e.g. vertebral split fracture)
- Preexisting Renal impairment
- Preexisting cochlea damage
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control Group
No additional treatment.
Routine iv.
antibiotic prophylaxis only.
|
|
Experimental: Vancomycin Group
Vancomycin powder is applied before wound closure.
Routine iv.
prophylaxis stays unchanged
|
Locally, intrawound applied vancomycin powder
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SSI rate
Time Frame: 1 year
|
Rate of superficial and deep surgical site infections (according to CDC criteria)
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
C-reactive protein
Time Frame: 7 days
|
Course of postoperative CRP levels
|
7 days
|
Revision rate
Time Frame: 1 year
|
Revision rate due to surgical site infections
|
1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Philipp Becker, MD, Orthopedic Hospital Speising
- Study Chair: Lukas Panzenboeck, MD, Orthopedic Hospital Speising
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- iVRCT1_4
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Spinal Fusion Acquired
-
Sewon Cellontech Co., Ltd.UnknownSpinal Fusion Acquired | Fusion of Spine (Disease)Korea, Republic of
-
Vanderbilt University Medical CenterCompletedSpinal Diseases | Spinal Stenosis | Spinal Fusion Acquired | Lesions of Lumbosacral Intervertebral DiscUnited States
-
Xtant MedicalRTI SurgicalRecruitingJoint Diseases | Musculoskeletal Diseases | Spinal Stenosis | Fusion of Spine | Spine | Spinal Fusion | Spinal Disease | Spinal Instability | Sacroiliac; Fusion | Fusion of Joint | SacroiliacUnited States, Spain, Germany
-
National Taiwan University HospitalTerminatedLumbar Fusion | Lumbar Spinal Fusion SurgeryTaiwan
-
Istituto Ortopedico RizzoliRecruiting
-
Istituto Ortopedico RizzoliCompleted
-
Aesculap AGCompleted
-
Hospital for Special Surgery, New YorkTerminated
-
NYU Langone HealthCompleted
Clinical Trials on Vancomycin
-
Case Western Reserve UniversityCystic Fibrosis FoundationWithdrawnCystic Fibrosis | Methicillin-resistant Staphylococcus AureusUnited States
-
St. Luke's Hospital, Chesterfield, MissouriCompletedClostridium Difficile Infection | Prophylaxis | Vancomycin
-
University of FloridaCompleted
-
Alberta Hip and Knee ClinicUniversity of CalgaryNot yet recruitingInfection of Total Hip Joint Prosthesis | Infection of Total Knee Joint Prosthesis
-
Memorial Sloan Kettering Cancer CenterCompletedHematologic Malignancies | Streptococcal SepsisUnited States
-
The Methodist Hospital Research InstituteRecruiting
-
Washington University School of MedicineTerminatedSurgical Site InfectionUnited States
-
William Beaumont HospitalsBeaumont HospitalWithdrawnClostridium Difficile ColitisUnited States
-
The Canberra HospitalUnknown
-
Universidad Autonoma de Nuevo LeonCompletedComplication of Surgical Procedure | Surgical Site InfectionMexico