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

Spectrum Health Hospitals

Status: Unknown

Conditions: Lumbar Pain

Treatments: Drug: Vancomycin

Study type: Interventional

Funder types: Other

Identifiers

NCT02299882

2012-166

Details and patient eligibility

About

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

Full description

Study will be blinded and randomized 1:1 to either Vancomycin Powder at closure or no vancomycin powder at closure.

Enrollment: 700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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700 participants in 2 patient groups

Vancomycin

Experimental group

Description:

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

Treatment:

Drug: Vancomycin

no vancomycin

No Intervention group

Description:

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.