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Suprafascial Vancomycin Powder for Prevention of Surgical Site Infections After Instrumented Posterior Spinal Fusion: A Randomized Controlled Phase-II Trial

2019-07-15 10:04:57 | BioPortfolio

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.

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.

Study Design

Conditions

Surgical Site Infection

Intervention

Vancomycin

Location

University Hostpital Bern, Department of Neurosurgery
Bern
Switzerland
3010

Status

Not yet recruiting

Source

University Hospital Inselspital, Berne

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-07-15T10:04:57-0400

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Medical and Biotech [MESH] Definitions

Infection occurring at the site of a surgical incision.

Strains of the genus Enterococcus that are resistant to the antibiotic VANCOMYCIN. The enterococci become resistant by acquiring plasmids carrying genes for VANCOMYCIN RESISTANCE.

Sterile clothing worn during surgical procedures to protect the surgical site from sources of contamination.

Methods and procedures for the diagnosis of disease or dysfunction by examination of the pathological site or operative field during surgical intervention.

Sterile fabric or fabric-like material used to isolate the surgical site from the rest of the body and other possible sources of contamination.

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