Spinal Fusion AcquiredPhase 4iVRCTNCT02631408
Intrawound Vancomycin Powder in Spinal Fusion Surgery
A Phase 4 study testing Vancomycin in people with Spinal Fusion Acquired, run by Orthopedic Hospital Vienna Speising at 1 site in Austria.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Fusion Acquired
- What is being tested?
- Vancomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 1 siteAustria
- Study dates
- Aug 2015to 1 Mar 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Spinal Fusion Acquired
- Being tested
- Vancomycin
- Keywords
- spinal fusion, topical antibiotics, vancomycin, surgical site infection
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VancomycinDrug
Also called Vancomycin Hydrochloride, Powder for Solution for Infusion
Locally, intrawound applied vancomycin powder
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
SSI rate
Rate of superficial and deep surgical site infections (according to CDC criteria)
Measured: 1 year
Secondary outcomes (2)
C-reactive protein
Course of postoperative CRP levels
Measured: 7 days
Revision rate
Revision rate due to surgical site infections
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startAug 2015
- Primary completion1 Mar 2019
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Fusion AcquiredStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthopedic Hospital Vienna Speising
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lukas Panzenboeck, Orthopedic Hospital Vienna Speising
- Investigators
- Philipp Becker, MD, Principal investigator, Orthopedic Hospital SpeisingLukas Panzenboeck, MD, Study chair, Orthopedic Hospital Speising
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631408
- Sponsor's protocol ID
- iVRCT1_4
- Acronym
- iVRCT
- Status last verified
- Mar 2021
- First submitted
- 12 Dec 2015
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 42102324
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Intrawound Vancomycin Powder to Reduce Surgical Site Infections in Spinal Fusion Surgery - A Prospective, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT02631408
- Acronym / sponsor ID
- iVRCT / iVRCT1_4
- Conditions
- Spinal Fusion Acquired
- Keywords
- spinal fusion, topical antibiotics, vancomycin, surgical site infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- Orthopedic Hospital Vienna SpeisingUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 16 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –No additional treatment. Routine iv. antibiotic prophylaxis only. |
| Vancomycin Group | Experimental | Drug: VancomycinVancomycin powder is applied before wound closure. Routine iv. prophylaxis stays unchanged |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VancomycinAlso: Vancomycin Hydrochloride, Powder for Solution for InfusionLocally, intrawound applied vancomycin powder | Drug | Vancomycin Group |
Primary outcome
SSI rate
Time frame: 1 year
Rate of superficial and deep surgical site infections (according to CDC criteria)
2 secondary outcomes
C-reactive protein
Time frame: 7 days
Revision rate
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Derived from this study: PubMed 42102324Panzenbock 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.
Related trials for Spinal Fusion Acquired
Not yet recruiting
Preoperative Risk Evaluation and Per ERAS Intervention in the Chinese Elderly Patients Underwent Spinal Fusion Surgery
Degenerative Spinal Disease, Elderly Patients
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philipp Becker, MD principal investigator
Orthopedic Hospital Speising
Lukas Panzenboeck, MD study chair
Orthopedic Hospital Speising
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vancomycin in people with Spinal Fusion Acquired, run by Orthopedic Hospital Vienna Speising at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SSI rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02631408, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.