Intrawound Vancomycin Powder in Spinal Fusion Surgery (iVRCT)
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|ClinicalTrials.gov Identifier: NCT02631408|
Recruitment Status : Active, not recruiting
First Posted : December 16, 2015
Last Update Posted : March 13, 2019
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
|Condition or disease||Intervention/treatment||Phase|
|Spinal Fusion Acquired||Drug: Vancomycin||Phase 4|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||308 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Application of Intrawound Vancomycin Powder to Reduce Surgical Site Infections in Spinal Fusion Surgery - A Prospective, Randomized, Controlled Trial|
|Study Start Date :||August 2015|
|Actual Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2020|
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 Name: Vancomycin Hydrochloride, Powder for Solution for Infusion
- SSI rate [ Time Frame: 1 year ]Rate of superficial and deep surgical site infections (according to CDC criteria)
- C-reactive protein [ Time Frame: 7 days ]Course of postoperative CRP levels
- Revision rate [ Time Frame: 1 year ]Revision rate due to surgical site infections
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02631408
|Orhopedic Hospital Speising|
|Vienna, Austria, 1130|
|Principal Investigator:||Philipp Becker, MD||Orthopedic Hospital Speising|
|Study Chair:||Lukas Panzenboeck, MD||Orthopedic Hospital Speising|