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


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.



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.


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.


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


Surgical Site Infection




University Hostpital Bern, Department of Neurosurgery


Not yet recruiting


University Hospital Inselspital, Berne

Results (where available)

View Results


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

Clinical Trials [1219 Associated Clinical Trials listed on BioPortfolio]

Current Surgical Practices and Surgical Site Infection at Ayder Comprehensive Specialized Hospital in Mekelle, Ethiopia

This study evaluates the current surgical practices at Ayder Comprehensive Specialized Hospital in comparison to the World Health Organization's Surgical Unit Based Safety Programme guidel...

Comparison Between Wound Vacuum Dressing and Standard Closure to Reduce Rates of Surgical Site Infections

Although outcomes of pancreaticoduodenectomy have improved, it remains a procedure with a high perioperative complication rate. Surgical site infection is one of the most common complicati...

Antibiotic Prophylaxis in Clean Surgery. Impact on Surgical Site Infection

This is a randomized control study of antibiotic uses in clean non prosthetic surgeries. One group will be given antibiotic prophylaxis, other will receive a placebo. The primary outcome w...

Abdominal Closure Bundle to Reduce Surgical Site Infection in Patients Undergoing C-sections. Cesarean Section Lead to Reduction in Surgical Site Infection? - A Randomized Controlled Trial

This study is a single center, randomized controlled trial investigating the use of an abdominal closure bundle to reduce surgical site infection in patients undergoing cesarean section. T...

Impact of Preoperative Bathing on Post Caesarean Section Surgical Site Infection

Surgical site infection (SSI) is the commonest hospital-acquired infection globally, and prevalence is much higher in the low-income countries. Caesarean delivery carries a 5-20 fold risk ...

PubMed Articles [15018 Associated PubMed Articles listed on BioPortfolio]

Effect of Hyperoxygenation During Surgery on Surgical Site Infection in Colorectal Surgery.

Despite the use of different surgical methods, surgical site infection is still an important cause of mortality and morbidity in patients and imposes a considerable cost on the healthcare system. Admi...

Preventing surgical site infection: conclusions from experts at EWMA.

In an Essity-sponsored symposium, titled 'Surgical site infection rates still high? We need to do more,' key opinion leaders discussed the importance of identifying, preventing and treating surgical s...

A case of a surgical-site infection with Staphylococcus condimenti.

Coagulase-negative staphylococci (CNS) are considered to have a medium or low pathogenic capacity when compared to S. aureus. Among the more harmless, CNS are those that are used in the food industry,...

Chlorhexidine Showers are Associated With a Reduction in Surgical Site Infection Following Spine Surgery: An Analysis of 4266 Consecutive Surgeries.

Surgical site infection (SSI) is a common complication following spinal surgery. Prevention is critical to maintaining safe patient care and reducing additional costs associated with treatment.

Risk Factors for Surgical Site Infection after Spinal Surgery: A Systematic Review and Meta-Analysis Based on Twenty-Seven Studies.

The current meta-analysis was conducted to explore and identify the risk factors of surgical site infection after spinal surgery based on qualified studies, and to gain insight into the management of ...

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.

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

Quick Search


Relevant Topics

Surgical treatments
Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...

Health care (or healthcare) is the diagnosis, treatment, and prevention of disease, illness, injury, and other physical and mental impairments in humans. Health care is delivered by practitioners in medicine, chiropractic, dentistry, nursing, pharmacy, a...

BioPortfolio - life science, medical devices and pharmaceutical conference
BioPortfolio is a leading news, information and knowledge resource covering the global life science industries impacted on by biotechnology. The site aims to provide the lay person, the researcher and the management executive with a single location to so...

Searches Linking to this Trial