Wound Infection Clinical Trial
Official title:
Randomized Control Trial of Vancomycin Powder Following Posterior Instrumented Spinal Surgery for Trauma
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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