Clinical trial NCT04017468: Suprafascial Vancomycin Powder for Prevention of Surgical Site Infections After Instrumented Posterior Spinal Fusion
Official title: Suprafascial Vancomycin Powder for Prevention of Surgical Site Infections After Instrumented Posterior Spinal Fusion
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Surgical Site Infection
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: University Hospital Freiburg
First posted: 2019-07-12
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 NOT clearly associated with age-related hearing impairment (presbycusis);
* 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;

Primary outcomes:
measure: Rate of superficial and deep SSIs (according to CDC criteria)
timeFrame: within 90 days following index surgery
Secondary outcomes:
measure: Rate of revision surgery due to SSIs
timeFrame: within 90 days following index surgery
measure: Rate of vancomycin-resistant bacterial infections in the treatment group
timeFrame: within 90 days following index surgery
measure: Rate of vancomycin-related adverse events both locally and systemically
timeFrame: within 90 days following index surgery
measure: Rate of wound healing disorders without SSI within
timeFrame: within 90 days following index surgery
measure: Rate of wound seromas
timeFrame: within 90 days following index surgery
measure: 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)
timeFrame: day 4, day 5, day 42, day 90
measure: 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)
timeFrame: day 4, day 5, day 42, day 90
measure: 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)
timeFrame: day 42 and day 90
measure: Length of hospital stay
timeFrame: within 90 days following index surgery
measure: Cost of treatment for cost analysis between both treatment arms
timeFrame: 1 year after index surgery
measure: Rate of bony fusion at the level of index surgery as assessed by CT
timeFrame: 1 year after index surgery
Other outcomes:
Locations:
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
state: Saint Gallen
city: Bern
country: Switzerland
facility: University Hostpital Bern, Department of Neurosurgery
city: Bern
country: Switzerland
facility: University Hostpital Bern, Department of orthopaedy
city: Bern
country: Switzerland
facility: Lindenhofspital Bern
city: Biel
country: Switzerland
facility: Spitalzentrum Biel
city: Luzern
country: Switzerland
facility: Klinik St. Anna
city: Zürich
country: Switzerland
facility: Schulthess Klinik
city: Zürich
country: Switzerland
facility: University Hospital Zurich, Department of Neurosurgery
Study officials:
affiliation: Inselspital Bern, Department of Neurosurgery
name: Schaer Ralph, MD
role: PRINCIPAL_INVESTIGATOR
References: