Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Vancomycin in Spine Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01977989
Recruitment Status : Unknown
Verified October 2013 by University of Tennessee.
Recruitment status was:  Enrolling by invitation
First Posted : November 7, 2013
Last Update Posted : November 7, 2013
Sponsor:
Collaborator:
Semmes-Murphey Foundation
Information provided by (Responsible Party):
University of Tennessee

Brief Summary:

The purpose of this study is to study how well using a powdered form of the antibiotic, vancomycin, inside the surgery wound prevents infection in patients undergoing instrumented spinal surgery for traumatic injury to the back.

Vancomycin is approved by the United States Food and Drug Administration (FDA) for treating certain kinds of bacteria. It is also used to prevent infections of the surgery site.

This will be a study in which the experimental treatment is compared to a standard (control) treatment. It will be prospective in nature, meaning that it will follow patients forward in time, and it will consist of a randomization process to determine who will receive the experimental treatment versus the standard (control) treatment.

The study will take place at Regional Medical Center (The MED). 140 subjects will be participating in this study.

The investigators hypothesize that the topical use of powder vancomycin will decrease the rate of surgical site infection.


Condition or disease Intervention/treatment Phase
Wound Infection Drug: Vancomycin Powder Phase 4

Detailed Description:
  1. Purpose: The purpose of this study is to examine the efficacy of prophylactic, locally applied vancomycin powder against surgical site infection in patients undergoing posterior instrumented spinal surgery for traumatic injury.
  2. Rationale: Surgical site infection (SSI) is a morbid complication with high cost in management of surgical spine patients. In this era of healthcare reforms, adjuvant therapies that not only improve quality, but also decrease cost, are considered of highest value. Despite the use of prophylactic systemic antibiotics and improved surgical technique, surgical site infections remain a serious perioperative concern. In comparison to systemic antibiotics, local delivery of antibiotics is attractive because high concentrations are achieved directly at these sites and systemic toxicity is limited.

    Prior investigations have primarily focused on the treatment of infected wounds with local antibiotics. Only a few studies have analyzed prophylactic use of local antibiotics during spine surgery. To date, there are no prospective, randomized studies on the prophylactic use of local antibiotics. The investigators will introduce local vancomycin powder into their practice of instrumented posterior spinal fusion for traumatic spine injury and determine efficacy in preventing postoperative infections.

  3. Study Population: The study will consist of adult patients undergoing posterior, instrumented spine surgery for traumatic injury.
  4. Research Design: This will be a prospective, randomized, controlled trial. The study will primarily be carried out through the University of Tennessee Health Science Center with all spinal surgery taking place at the Regional Medical Center at Memphis. Once patients with traumatic spine injury have been deemed eligible through several other criteria described later in the application, they will be placed into one of two randomized groups:

1) The control group will consist of patients who are administered systemic prophylactic antibiotic only.

2) The treatment group will consist of patients who are administered systemic prophylactic antibiotic along with vancomycin powder within the surgical site.

5. Study/Project Procedures: Patients who meet the entry criteria and agree to participate in the trial will be randomized to receive intraoperative vancomycin powder within the surgical wound or not. In all patients, vancomycin 1g and cefazolin 2g IV will be given within 60min of skin incision. If an allergy to cefazolin exists, 900mg of clindamycin IV will be used in its place. Cefazolin 1g IV will be given q6hr during surgery and continued q8hr post surgery for 24hrs, regardless of whether a surgical drain is in place. One to three liters of normal saline will be used for irrigation purposes during surgical procedure. Prior to wound closure, vancomycin powder will be topically applied both above (50% of dose) and below (50% of dose) the deep muscular fascia in patients participating in the treatment arm of the study. For surgeries involving 3 contiguous spinal segments or less, 500mg of vancomycin (1/2 vial) will be applied. For surgeries involving greater than 3 contiguous spinal segments, 1gm will be applied.

6. Outcome Measures: All patients will be followed on an inpatient or outpatient basis (as applicable) for a period of 12 months post-operatively. Residents, attendings and study coordinators will perform data collection. All patients with suspected wound infection will undergo MRI with contrast for verification, unless there is gross evidence of infection (ex. purulent drainage from the incision, erythema and swelling). A CT scan with contrast will be obtained in those patients who are unable to undergo MRI for various reasons (pacemaker, metallic foreign bodies, fresh vascular stents, etc.). All wound data will be collected and recorded in specific data forms at each clinical encounter.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Randomized Control Trial of Vancomycin Powder Following Posterior Instrumented Spinal Surgery for Trauma
Study Start Date : October 2013
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: No Vancomycin Powder
Patients who only receive IV Vancomycion prior to surgery. No Vancomycin powder is administered.
Active Comparator: Vancomycin Powder
Patients who receive Vancomycin powder in the surgical site following surgery.
Drug: Vancomycin Powder
For surgeries involving 3 contiguous spinal segments or less, 500mg of vancomycin will be applied topically. For surgeries involving more than 3 contiguous spinal segments, 1gm of vancomycin will be applied topically to the surgical site.




Primary Outcome Measures :
  1. Surgical Site Infection [ Time Frame: 12 Months ]
    All patients with suspected wound infection will undergo MRI with contrast for verification, unless there is gross evidence of infection. A CT scan with contrast will be obtained in those patients who are unable to undergo MRI for various reasons.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Hemodynamically stable
  • 18 years of age or older
  • Undergoing spinal fusion for traumatic cervical, thoracic, or lumbar injury

Exclusion Criteria:

  • Septic patient
  • Open or penetrating spinal injury
  • Active infection
  • Active cancer
  • Known allergy to vancomycin
  • Previous surgery in surgical site
  • History of radiation therapy at surgical site
  • Immunosuppressed (disease or drug-induced)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01977989


Locations
Layout table for location information
United States, Tennessee
Regional Medical Center (The MED)
Memphis, Tennessee, United States, 38103
Sponsors and Collaborators
University of Tennessee
Semmes-Murphey Foundation

Publications:

Layout table for additonal information
Responsible Party: University of Tennessee
ClinicalTrials.gov Identifier: NCT01977989     History of Changes
Other Study ID Numbers: 13-02478-FB
First Posted: November 7, 2013    Key Record Dates
Last Update Posted: November 7, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Layout table for MeSH terms
Wound Infection
Infection
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents