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

Conditions: Postoperative surgical site infections (deep and superficial) after spinal fusion surgery
MedDRA version: 18.0Level: LLTClassification code 10074392Term: Deep postoperative wound infectionSystem Organ Class: 100000004862
MedDRA version: 18.0Level: LLTClassification code 10074393Term: Superficial postoperative wound infectionSystem Organ Class: 100000004862
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

Registration Number: EUCTR2014-002096-29-AT

Lead Sponsor: Speising Orthopaedic Hospital Vienna

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

•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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): Revision rate, C-reactive protein levels;Timepoint(s) of evaluation of this end point: CRP: closely throughout discharge<br>Revision rate: throughout discharge and 6-weeks postoperatively