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

Lumbar Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02299882
• Other study ID #: 2012-166
• Status: Recruiting
• Phase: N/A
• First received: February 20, 2013
• Last updated: November 21, 2014
• Start date: August 2012
• Est. completion date: January 2016

Study information

• Verified date: February 2013
• Source: Spectrum Health Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: January 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Lumbar Pain

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Spectrum Health Hospitals	Grand Rapids	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Spectrum Health Hospitals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical wound infection rate, both deep and superficial infections		12 weeks post surgery	No
Secondary	Post-operative rate of MRSA infections.		12 weeks post surgery	No