Using Locally Applied Antibiotic Powder in Spine Surgery to Reduce Postoperative Wound Infections

Application of Intrawound Vancomycin Powder in Spinal Fusion Surgery to Reduce Postoperative Surgical Site Infections - A Prospective Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002096-29-AT

Enrollment

440

Registered

2015-06-18

Start date

2015-07-20

Completion date

Unknown

Last updated

2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative surgical site infections (deep and superficial) after spinal fusion surgery MedDRA version: 18.0 Level: LLT Classification code 10074392 Term: Deep postoperative wound infection System Organ Class: 100000004862 MedDRA version: 18.0 Level: LLT Classification code 10074393 Term: Superficial postoperative wound infection System Organ Class: 100000004862

Interventions

Trade Name: Vancomycin Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: VANCOMYCIN CAS Number: 1404-90-6 Concentration unit: mg milligram(s) Concentration type: equal Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 240

Exclusion criteria

Exclusion criteria: • Preoperative inflammatory or infectious state (C-reactive protein levels above 5mg/l) • Diabetes mellitus type I or II • Allergic to vancomycin, teicoplanin or penicillin • Preexisting malignant disease • 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 • The surgery cannot be undertaken for any other reasons

Design outcomes

Primary

Measure	Time frame
Main Objective: Rate of surgical site infections (deep and superficial) according to CDC criteria;Secondary Objective: Evaluating the revision rate and c-reactive protein levels after vancomycin usage;Primary end point(s): Rate of surgical site infections according to CDC definitions;Timepoint(s) of evaluation of this end point: Throughout discharge and 6-weeks postoperatively	—

Secondary

Measure	Time frame
Secondary end point(s): Revision rate, C-reactive protein levels;Timepoint(s) of evaluation of this end point: CRP: closely throughout discharge Revision rate: throughout discharge and 6-weeks postoperatively	—

Countries

Austria

Contacts

Public ContactDept. for Spine Surgery

Speising Orthopaedic Hospital Vienna

lukas.panzenboeck@oss.at

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: May 10, 2026