NCT02299882

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
700

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2013

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

November 24, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

November 24, 2014

Status Verified

February 1, 2013

Enrollment Period

3 years

First QC Date

February 20, 2013

Last Update Submit

November 21, 2014

Conditions

Lumbar Pain

Keywords

Posterior spine surgeryinfectionvancomycinsurgical wound infection

Outcome Measures

Primary Outcomes (1)

  • Surgical wound infection rate, both deep and superficial infections

    12 weeks post surgery

Secondary Outcomes (1)

  • Post-operative rate of MRSA infections.

    12 weeks post surgery

Study Arms (2)

Vancomycin

EXPERIMENTAL

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

Drug: Vancomycin

no vancomycin

NO INTERVENTION

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

VancomycinDRUG

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.

Vancomycin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spectrum Health Hospitals

Grand Rapids, Michigan, 49503, United States

RECRUITING

MeSH Terms

Conditions

Low Back PainInfectionsSurgical Wound Infection

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsWound InfectionPostoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

GlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Jason Squires, DO

    Corewell Health West

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

February 20, 2013

First Posted

November 24, 2014

Study Start

August 1, 2012

Primary Completion

August 1, 2015

Study Completion

January 1, 2016

Last Updated

November 24, 2014

Record last verified: 2013-02

Locations

US(1)