Suprafascial Vancomycin Powder for Prevention of Surgical Site Infections After Instrumented Posterior Spinal Fusion (VANCO)
Primary Purpose
Surgical Site Infection
Status
Recruiting
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Vancomycin
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Site Infection
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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;
- 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;
Sites / Locations
- University Hostpital Bern, Department of NeurosurgeryRecruiting
- University Hostpital Bern, Department of orthopaedyRecruiting
- Lindenhofspital BernRecruiting
- Spitalzentrum BielRecruiting
- University Hospital Zurich, Department of NeurosurgeryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Treatment Arm
Control Arm
Arm Description
The powdered vancomycin will be placed subcutaneously over the closed muscle fascia (suprafascially) at the end of the surgery during wound closure.
The control group receiving only a standard preoperative antimicrobial prophylaxis administered intravenously.
Outcomes
Primary Outcome Measures
Rate of superficial and deep SSIs (according to CDC criteria)
Secondary Outcome Measures
Rate of revision surgery due to SSIs
Rate of vancomycin-resistant bacterial infections in the treatment group
Rate of vancomycin-related adverse events both locally and systemically
Rate of wound healing disorders without SSI within
Rate of wound seromas
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)
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)
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)
Length of hospital stay
Cost of treatment for cost analysis between both treatment arms
Rate of bony fusion at the level of index surgery as assessed by CT
Full Information
NCT ID
NCT04017468
First Posted
July 9, 2019
Last Updated
July 17, 2023
Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
University Hospital Freiburg
1. Study Identification
Unique Protocol Identification Number
NCT04017468
Brief Title
Suprafascial Vancomycin Powder for Prevention of Surgical Site Infections After Instrumented Posterior Spinal Fusion
Acronym
VANCO
Official Title
Suprafascial Vancomycin Powder for Prevention of Surgical Site Infections After Instrumented Posterior Spinal Fusion
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
University Hospital Freiburg
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
450 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm
Arm Type
Active Comparator
Arm Description
The powdered vancomycin will be placed subcutaneously over the closed muscle fascia (suprafascially) at the end of the surgery during wound closure.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
The control group receiving only a standard preoperative antimicrobial prophylaxis administered intravenously.
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of superficial and deep SSIs (according to CDC criteria)
Time Frame
within 90 days following index surgery
Secondary Outcome Measure Information:
Title
Rate of revision surgery due to SSIs
Time Frame
within 90 days following index surgery
Title
Rate of vancomycin-resistant bacterial infections in the treatment group
Time Frame
within 90 days following index surgery
Title
Rate of vancomycin-related adverse events both locally and systemically
Time Frame
within 90 days following index surgery
Title
Rate of wound healing disorders without SSI within
Time Frame
within 90 days following index surgery
Title
Rate of wound seromas
Time Frame
within 90 days following index surgery
Title
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)
Time Frame
day 4, day 5, day 42, day 90
Title
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)
Time Frame
day 4, day 5, day 42, day 90
Title
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)
Time Frame
day 42 and day 90
Title
Length of hospital stay
Time Frame
within 90 days following index surgery
Title
Cost of treatment for cost analysis between both treatment arms
Time Frame
1 year after index surgery
Title
Rate of bony fusion at the level of index surgery as assessed by CT
Time Frame
1 year after index surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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;
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ralph Schaer, MD
Phone
+41316322409
Email
ralph.schaer@insel.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole Soell
Phone
+41316323164
Email
Nicole.Soell@insel.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Schaer Ralph, MD
Organizational Affiliation
Inselspital Bern, Department of Neurosurgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hostpital Bern, Department of Neurosurgery
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ralph Schaer, MD
Phone
+41316322409
Email
ralph.schaer@insel.ch
First Name & Middle Initial & Last Name & Degree
Nicole Soell
Phone
+41316323164
Email
nicole.soell@insel.ch
Facility Name
University Hostpital Bern, Department of orthopaedy
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Albers Christoph, MD
Phone
+41 31 632 23 06
Email
christoph.albers@insel.ch
Facility Name
Lindenhofspital Bern
City
Bern
ZIP/Postal Code
3012
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Ulrich, MD
Phone
+41 31 300 88 11
Email
ch.ulrich@hin.ch
Facility Name
Spitalzentrum Biel
City
Biel
ZIP/Postal Code
2501
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jost Gregory, MD
Phone
+41 32 324 43 30
Email
gregory.jost@szb-chb.ch
Facility Name
University Hospital Zurich, Department of Neurosurgery
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Bellut, MD
Phone
+41 44 255 26 60
Email
david.bellut@usz.ch
12. IPD Sharing Statement
Plan to Share IPD
No
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Suprafascial Vancomycin Powder for Prevention of Surgical Site Infections After Instrumented Posterior Spinal Fusion
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