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Does Vancomycin Reduce Surgical Site Infections in Spine Surgery

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ClinicalTrials.gov Identifier: NCT03839914
Recruitment Status : Not yet recruiting
First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Jason Pui Yin Cheung, The University of Hong Kong

Tracking Information
First Submitted Date  ICMJE February 9, 2019
First Posted Date  ICMJE February 15, 2019
Last Update Posted Date February 15, 2019
Estimated Study Start Date  ICMJE April 1, 2020
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2019)
Surgical site infection rate [ Time Frame: one year ]
To determine whether the difference in surgical site infection rate between the intervention (vancomycin use) and control groups. Our criteria for a surgical site infection is as defined by the Centers for Disease Control and Prevention. The definition includes an infection occurring within 1 year postoperatively with at least one of the following: a) Purulent drainage; b) Organisms isolated from an aseptically obtained culture of fluid or tissue c) At least one sign of symptom of infection: pain or tenderness, localized swelling, redness, or heat or fever d) Diagnosis of surgical site infection by the surgeon
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2019)
  • Cost-effectiveness of vancomycin use [ Time Frame: one year ]
    Determination of which disease group is most cost-effective in terms of cost per surgical site infection episode reduced. Will identify the highest risk group (i.e. deformity or tumor surgery) and see whether the risk of infection is significantly different between intervention and control groups as compared to perceived less risk groups (i.e. simple decompression surgery, no implants). Cost items include cost of vancomycin drug, hospitalization days, prolonged antibiotic use, repeated operations for debridement
  • Serum vancomycin level [ Time Frame: Three days postoperatively ]
    3 days postoperative serum assessment of vancomycin levels to identify any vancomycin toxicity in serum
  • Renal function test [ Time Frame: Three days postoperatively ]
    3 days postoperative serum assessment of renal function tests to identify any renal impairment
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Does Vancomycin Reduce Surgical Site Infections in Spine Surgery
Official Title  ICMJE Does Local Vancomycin Application Reduce Surgical Site Infections in Patients Undergoing Open Posterior Spinal Surgery
Brief Summary Surgical site infections are not uncommon, especially in specific high-risk groups including spinal deformity and tumor (i.e. metastatic spine surgery) surgery. Well-recognized measures have been adopted to reduce surgical site infection, and the use of topical vancomycin powder has gained popularity in recent years. Given the lack of high-quality evidence for the use of topical vancomycin to reduce surgical site infections in open posterior spine surgery, which is currently the most common approach to spine surgery, it is crucial to study the use of vancomycin powder in reducing surgical site infections. This study is a prospective, single-blinded open label randomized controlled trial, with one arm of patients having local administration of 1g vancomycin powder which will be placed in the deep wound and subcutaneous layer prior to closure of surgical site by the orthopaedic surgeon, whereas the control arm will be without such application of vancomycin. Both arms of patients will still be undergoing the same operation procedures, as well as postoperative local wound drainage and wound care. This study will provide insights on the reduction rate in superficial and/or deep surgical site infection, and also assess the cost-effectiveness of using topical vancomycin in reducing surgical site infection between different disease groups, as well as any postoperative serum vancomycin toxicity and renal impairment. These proposed findings will provide valuable information for clinicians and institutions on future measures for surgical site infection of open posterior spine surgery.
Detailed Description

Objectives: To determine whether local application of vancomycin powder reduces the rate of surgical site infections in open posterior spinal surgery, any risks with its use and to determine which type of disease profile is most cost-effective.

Hypothesis to be tested: Local application of vancomycin powder reduces surgical site infection rates, is not toxic to humans and is most cost-effective in high-risk disease groups including deformity correction and tumor surgery.

Design and subjects: Randomized controlled trial of all patients undergoing open posterior spinal surgery.

Instruments: Parameters include age, gender, smoking and drinking history, pathology (deformity, tumor, trauma, degenerative), location and spinal levels of surgery, if instrumentation is used, operative time, blood loss, need for transfusion, significant co-morbidities including diabetes mellitus, renal failure, immunocompromised state, and dural tear events.

Interventions: Patients are randomized into the treatment group where 1g of vancomycin powder is administered to the deep and superficial spinal wound, and the control group without vancomycin powder use.

Main outcome measures: Primary outcome is the rate of surgical site infection. Secondary outcomes include vancomycin toxicity measured by vancomycin levels and renal function for three consecutive postoperative days, and cost-effectiveness calculation for each disease group. Additionally for those undergoing fusion surgery, 1-year follow-up assessment for fusion rates.

Data analysis: Evaluation by independent sample t-test and chi-square test according to intention-to-treat and per-protocol principles.

Expected results: Local administration of vancomycin powder reduces surgical site infections, is not toxic, and the most cost-effective disease groups are deformity correction and tumor surgery.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Single-blinded open-label randomized controlled trial
Masking: Double (Investigator, Outcomes Assessor)
Masking Description:
This will be a single blinded trial as patients will not know their treatment allocation until the termination of study. Operating surgeons cannot be blinded to allocation. However, all clinical and radiological outcomes will be evaluated by an independent researcher who is blinded to the allocation. This researcher will be blinded to the study treatment throughout the study period.
Primary Purpose: Treatment
Condition  ICMJE
  • Spinal Degeneration
  • Spinal Deformity
  • Trauma
  • Spinal Tumor
  • Surgical Site Infection
Intervention  ICMJE Drug: Vancomycin powder
For the intervention group, the use of 1g vancomycin powder to be placed in the deep wound and subcutaneous layer prior to closure.
Study Arms  ICMJE
  • Active Comparator: Intervention - Vancomycin
    Intervention: 1g vancomycin powder locally applied to the deep wound and subcutaneous layer prior to closure.
    Intervention: Drug: Vancomycin powder
  • No Intervention: Control - No vancomycin application
    No intervention, control group All other wound closure procedure and wound care and monitoring are the same
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 12, 2019)
170
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2022
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • all pediatric (<18 years) and adult (≥18 years) patients undergoing open posterior spinal surgery. Disease groups studied include degenerative, deformity, trauma, and tumor surgery

Exclusion Criteria:

  • patients treated with primary spine infection (i.e. spondylodiscitis), minimally invasive surgery, anterior-only surgical approaches, and pediatric patients with adolescent idiopathic scoliosis undergoing deformity correction surgery
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jason PY Cheung (852) 22554581 cheungjp@hku.hk
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03839914
Other Study ID Numbers  ICMJE Study protocol 1.0
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr. Jason Pui Yin Cheung, The University of Hong Kong
Study Sponsor  ICMJE The University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The University of Hong Kong
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP