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Surgical Site InfectionPhase 2VANCONCT04017468

Suprafascial Vancomycin Powder for Prevention of Surgical Site Infections After Instrumented Posterior Spinal Fusion

A Phase 2 study testing Vancomycin in people with Surgical Site Infection, run by Insel Gruppe AG, University Hospital Bern at 7 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Surgical site infections (SSI) after spine surgery may occur in up to 12% of cases and can lead to increased morbidity, and healthcare costs In this randomized controlled trial the investigators aim to prospectively investigate the efficacy and safety of suprafascial intrawound vancomycin powder in reducing the rate… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Surgical Site Infection
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
450 participants
Where
7 sitesSwitzerland
Study dates
15 Oct 2019to 31 Jul 2026
Phase
Phase 2
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

  • Patients ≥ 18 years of age requiring open instrumented dorsal spinal fusion of at least 1 level (involving two adjacent vertebras and one intervertebral disc)
  • Signed informed consent

Who cannot join

  • Preoperative ongoing infectious disease present as judged by primary surgeon (based on lab results and clinical assessment);
  • Previous spine surgery at index level within last 90 days;
  • Known allergy to vancomycin;
  • Percutaneous or transmuscular instrumentation (minimally-invasive surgery) only without lumbar interbody fusion;
  • Postoperative radiotherapy of surgical site required (e.g. for tumor)
  • Preexisting cochlea damage OR known history of hearing loss NOT clearly associated with age-related hearing impairment (presbycusis);
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  • Renal insufficiency with stage 4 chronic kidney disease (CKD) with a glomerular filtration rate (GFR) of 15-30 ml/min or worse;
  • Pregnancy or breastfeeding women;
  • Participation in other ongoing clinical trials;
  • Patients lacking capacity to consent;

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Switzerland7 sites

  • University Hostpital Bern, Department of Neurosurgery

    Bern, 3010

  • University Hostpital Bern, Department of orthopaedy

    Bern, 3010

  • Lindenhofspital Bern

    Bern, 3012

  • Spitalzentrum Biel

    Biel, 2501

  • Klinik St. Anna

    Lucerne, 6006

  • Kantonsspital St. Gallen

    Sankt Gallen, Canton of St. Gallen, 9007

  • University Hospital Zurich, Department of Neurosurgery

    Zurich, 8091

Other trials in Switzerland

About this study

Surgical site infections (SSI) after spine surgery may occur in up to 12% of cases and can lead to increased morbidity, and healthcare costs In this randomized controlled trial the investigators aim to prospectively investigate the efficacy and safety of suprafascial intrawound vancomycin powder in reducing the rate of SSIs after instrumented spinal fusion surgery. Secondary aims of the study are the incidence of vancomycin-related complications, vancomycin-resistant bacterial infections in the treatment arm as well as the rate of revision surgeries due to SSIs.

Read the detailed description

Background:

Surgical site infections (SSI) after spine surgery may occur in up to 12% of cases and can lead to increased morbidity, and healthcare costs. Numerous retrospective studies suggest the use of intrawound (subfascial) vancomycin powder in spine surgery to be protective against SSIs. Adverse events, such as seroma formation or neurotoxicity may be associated with the subfascial use of vancomycin powder in high doses in direct proximity to exposed neural structures. Only one retrospective study investigated the use of suprafascial vancomycin powder. The use of intrawound vancomycin powder is controversial and there is a paucity of well-designed prospective trials evaluating its efficacy and safety in spine surgery.

Objective:

The main objective of this Trial is to evaluate the efficacy and safety of suprafascially applied vancomycin powder in open instrumented spine surgery to prevent surgical site infections and inform a future phase-III trial.

Methods:

In addition to standard preoperative systemic antibiotic prophylaxis (SAP), patients in the treatment arm will receive 1-2 g of vancomycin powder (VP) applied above the closed muscle fascia (suprafascial) into the wound at conclusion of the surgery. Patients in the control arm will not receive additional intrawound vancomycin powder. All other intra- and perioperative procedures will be conducted according to standard of practice (SOP) at the respective Trial site. All patient follow-ups and assessment of the surgical site will be observational in nature and adhere to Standard Operating Procedure (SOP) of the Trial site. All patients will be followed up clinically with conventional radiographs after 6 weeks and 3 months after surgery. At each follow-up, clinical assessment and inspection of the surgical site (the wound) will be performed by a blinded assessor (who was not present at index surgery). In cases of evident or suspected SSI standard blood samples and - if required to rule out or confirm a deep SSI - a MRI will be ordered.

Being tested
Vancomycin
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

    Patients randomized into the treatment arm will receive 1-2 g of vancomycin powder (Vancocin® i.v.) which will be administered above the closed muscle fascia (suprafascially) before closing the subcutaneous tissue and skin. The dose of the drug will depend on the length of the skin incision: 1 g for incisions ≤ 20 cm, 2 g for incisions ≥ 20 cm.

Study groups in NCT04017468
Study groupRoleWhat they receive
Treatment ArmActive comparatorThe powdered vancomycin will be placed subcutaneously over the closed muscle fascia (suprafascially) at the end of the surgery during wound closure.
Receives: Drug: Vancomycin
Control ArmNo interventionThe control group receiving only a standard preoperative antimicrobial prophylaxis administered intravenously.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of superficial and deep SSIs (according to CDC criteria)

    Measured: within 90 days following index surgery

Secondary outcomes (11)

  1. Rate of revision surgery due to SSIs

    Measured: within 90 days following index surgery

  2. Rate of vancomycin-resistant bacterial infections in the treatment group

    Measured: within 90 days following index surgery

  3. Rate of vancomycin-related adverse events both locally and systemically

    Measured: within 90 days following index surgery

  4. Rate of wound healing disorders without SSI within

    Measured: within 90 days following index surgery

  5. Rate of wound seromas

    Measured: within 90 days following index surgery

  6. numeric rating scale (NRS) to assess pain intensity self-reported by the patient (Score 0-10 with 0 representing no pain, and 10 maximum pain intensity) at Visits 3, 4, 5 and 6 for neck or back pain depending on surgical level (cervical or lumbosacral)

    Measured: day 4, day 5, day 42, day 90

  7. numeric rating scale (NRS) to assess pain intensity self-reported by the patient (Score 0-10 with 0 representing no pain, and 10 maximum pain intensity) at Visits 3, 4, 5 and 6 for leg or arm pain (cervical or lumbosacral)

    Measured: day 4, day 5, day 42, day 90

  8. Quality of life (EuroQoL 5D-5L), Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/ Depression (rating from no problems to extreme problems) and health status self rating by patient (Score 0-100, 0 the worst health and 100 the best health)

    Measured: day 42 and day 90

  9. Length of hospital stay

    Measured: within 90 days following index surgery

  10. Cost of treatment for cost analysis between both treatment arms

    Measured: 1 year after index surgery

  11. Rate of bony fusion at the level of index surgery as assessed by CT

    Measured: 1 year after index surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2019
  2. Study start15 Oct 2019
  3. Primary completion10 Jun 2026
  4. Study completion31 Jul 2026

Resources

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
450 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04017468
Sponsor's protocol ID
2019-01143
Other IDs
2019
Acronym
VANCO
Status last verified
Aug 2026
First submitted
9 Jul 2019
Last updated
5 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Schar RT, Branca M, Fischer U, Zimmerli S, Soll N. Intrawound vancomycin powder for prevention of surgical site infections after open instrumented posterior spinal fusion (VANCO Trial)-methodology of a randomized, controlled, multicenter study. Trials. 2025 Sep 24;26(1):344. doi: 10.1186/s13063-025-09095-z.

    PubMed 40993807

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vancomycin in people with Surgical Site Infection, run by Insel Gruppe AG, University Hospital Bern at 7 sites in Switzerland.

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 2 inclusion and 10 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 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Switzerland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Rate of superficial and deep SSIs (according to CDC criteria) (time frame: within 90 days following index surgery). 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 NCT04017468, 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 5 Aug 2026.

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