Intrawound Vancomycin Powder in Spinal Fusion Surgery

Spinal Fusion Acquired Clinical Trial

— iVRCT  

Official title:

Application of Intrawound Vancomycin Powder to Reduce Surgical Site Infections in Spinal Fusion Surgery - A Prospective, Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02631408
• Other study ID #: iVRCT1_4
• Status: Completed
• Phase: Phase 4
• Start date: August 2015
• Est. completion date: March 1, 2021

Study information

• Verified date: March 2021
• Source: Orthopedic Hospital Vienna Speising
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 308
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Fusion Acquired
• Surgical Wound Infection

Intervention

Drug:
• Vancomycin
Locally, intrawound applied vancomycin powder

Locations

Country	Name	City	State
Austria	Orhopedic Hospital Speising	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Orthopedic Hospital Vienna Speising

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SSI rate	Rate of superficial and deep surgical site infections (according to CDC criteria)	1 year
Secondary	C-reactive protein	Course of postoperative CRP levels	7 days
Secondary	Revision rate	Revision rate due to surgical site infections	1 year