Intrawound Vancomycin Powder in Spinal Fusion Surgery

NCT02631408 | Completed Phase 4

• 1 other identifier: iVRCT1_4
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

Brief Summary

Vancomycin powder (for solution for Infusion) will be investigated (off-label usage) in spinal fusion surgery. The powder will be locally administered into to the wound cavity before wound closure. Hypothesis: Locally applied vancomycin powder leads to a reduction in postoperative surgical site infections

Conditions

Spinal Fusion Acquired

Keywords

spinal fusion; topical antibiotics; vancomycin; surgical site infection

Outcome Measures

Primary Outcomes (1)

• SSI rate

  Rate of superficial and deep surgical site infections (according to CDC criteria)

  1 year

Secondary Outcomes (2)

• C-reactive protein

  7 days

• Revision rate

  1 year

Study Arms (2)

Control Group

NO INTERVENTION

No additional treatment. Routine iv. antibiotic prophylaxis only.

Vancomycin Group

EXPERIMENTAL

Vancomycin powder is applied before wound closure. Routine iv. prophylaxis stays unchanged

Drug: Vancomycin

Interventions

Vancomycin DRUG

Locally, intrawound applied vancomycin powder

Also known as: Vancomycin Hydrochloride, Powder for Solution for Infusion

Vancomycin Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned TLIF (transforaminal lumbar interbody fusion) or PLIF (posterolateral lumbar interbody fusion) surgery
• TLIF/PLIF fusion length of one or two motion-segments OR
• One motion-segment TLIF/PLIF in conjunction with one motion-segment decompression surgery or microscopic disc surgery (microdiscectomy)
• Fusions within L1 (first lumbar vertebra) through S1 (sacrum)
• Age of 18-years or older
• Signed informed consent

You may not qualify if:

• Preoperative inflammatory or infectious state (C-reactive protein levels above 10mg/l)
• Allergic to vancomycin, teicoplanin or penicillin
• Preexisting auto-immune disease with an impaired immune system
• Current post-traumatic vertebral injury (e.g. vertebral split fracture)
• Preexisting Renal impairment
• Preexisting cochlea damage
• Pregnancy

Sponsors & Collaborators

• Orthopedic Hospital Vienna Speising: lead

Study Sites (1)

Orhopedic Hospital Speising

Vienna, 1130, Austria

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Vancomycin; Powders; Solutions

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Philipp Becker, MD

  Orthopedic Hospital Speising

  PRINCIPAL INVESTIGATOR

• Lukas Panzenboeck, MD

  Orthopedic Hospital Speising

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Lukas Panzenboeck

Study Record Dates

• First Submitted: December 12, 2015
• First Posted: December 16, 2015
• Study Start: August 1, 2015
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2021
• Last Updated: March 3, 2021

Record last verified: 2021-03

Locations

AU (1)