Intrawound Vancomycin Powder in Spinal Fusion Surgery | NCT02631408

Studies
Intrawound Vancomycin Powder in Spinal Fusion Surgery

NCT02631408

Sponsor

Orthopedic Hospital Vienna Speising

Status

Completed

Last Update Posted

Mar 3, 2021Actual

Enrollment

308Actual

Phase

Phase 4

Conditions

Spinal Fusion Acquired

Interventions

Vancomycin

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2015

Primary Completion Date

Mar 1, 2019Actual

Completion Date

Mar 1, 2021Actual

First Submitted Date

Dec 12, 2015

First Submission Date that Met QC Criteria

Dec 12, 2015

First Posted Date

Dec 16, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2021

Last Update Posted Date

Mar 3, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lukas Panzenboeck, Dr. Lukas Panzenboeck, Orthopedic Hospital Vienna SpeisingPrincipal Investigator

Lead Sponsor

Orthopedic Hospital Vienna SpeisingOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

308Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control Group	No Intervention	No additional treatment. Routine iv. antibiotic prophylaxis only.
Vancomycin Group	Experimental	Vancomycin powder is applied before wound closure. Routine iv. prophylaxis stays unchanged	Drug: Vancomycin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vancomycin	Drug	Locally, intrawound applied vancomycin powder	Vancomycin Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SSI rate	Rate of superficial and deep surgical site infections (according to CDC criteria)	1 year

Secondary Outcomes

Measure	Description	Time Frame
C-reactive protein	Course of postoperative CRP levels	7 days
Revision rate	Revision rate due to surgical site infections	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Philipp Becker, MD	Orthopedic Hospital Speising	Principal Investigator
Lukas Panzenboeck, MD	Orthopedic Hospital Speising	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Orhopedic Hospital Speising		Vienna		1130	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42102324	Derived	Panzenbock LF, Abdel Nour G, Durrschnabel DL, Krepler P. Postoperative C-Reactive Protein Trajectories in Spine Surgery - Influence of Vancomycin Powder: A Secondary Analysis of a Prospective Randomized Controlled Trial. Global Spine J. 2026 May 8:21925682261450878. doi: 10.1177/21925682261450878. Online ahead of print.

ID	Term
D014946	Wound Infection
D007239	Infections
D011183	Postoperative Complications
D010335	Pathologic Processes

ID	Term
D014640	Vancomycin
D011208	Powders
D012996	Solutions

ID	Term
D006020	Glycopeptides
D006001	Glycoconjugates
D002241	Carbohydrates
D010455	Peptides