Recruiting

VancomycinSurgical Infection Rates With Adjunct Vancomycin Compared to Standard Peri-Operative IV Antibiotics

Sponsor:

Spectrum Health Hospitals

Code:

NCT02299882

Conditions

Lumbar Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Vancomycin

Study Details

Brief summary:

Determine the effect of Vancomycin Powder added to the surgical wound at closure on surgical infection rates.

Conditions

Lumbar Pain

Study ID

NCT02299882

Start date

Aug, 2012

Status verified date

Feb, 2013

Completion date

Jan, 2016

Anticipated

Primary completion date

Aug, 2015

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

All adult, 18 years or greater undergoing posterior approach spinal surgery

Exclusion Criteria:

Prisoner, pregnant women, patient under the age of 18, those of diminished decision making capacity.
patients with known reaction to Vancomycin.
patients having surgery specifically for spine infection
patients having ADCF or ALIF

Study Design

Enrollment

700 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Vancomycin

Patient will receive Vancomycin powder to the incision just before skin closure

no intervention: no vancomycin

Patient will be randomized to either vancomycin powder or no vancomycin powder. This arm the patient will not have the powder placed in the incision before skin closure.

Interventions

Vancomycin

Patient will be randomized to either vancomycin or no vancomycin. This treatment will take place prior to the closure of the incision from back surgery.

Primary outcome measure

Surgical wound infection rate, both deep and superficial infections [ Time Frame: 12 weeks post surgery ]

Central Contacts and Locations

Locations

Spectrum Health Hospitals

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Nichole Rodrique

616-258-3886 Nichole.Rodrique@spectrumhealth.org

Principal Investigator:

Jason Squires, DO

More Information

Sponsor

Spectrum Health Hospitals

Last update posted

Nov 24, 2014

Last verified

Feb, 2013

Keywords

Posterior spine surgery
infection
vancomycin
surgical wound infection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Spectrum Health Hospitals on 2014-11-24.