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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

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.

Condition or disease Intervention/treatment Phase
Spinal Degeneration Spinal Deformity Trauma Spinal Tumor Surgical Site Infection Drug: Vancomycin powder Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
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
Official Title: Does Local Vancomycin Application Reduce Surgical Site Infections in Patients Undergoing Open Posterior Spinal Surgery
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Intervention - Vancomycin
Intervention: 1g vancomycin powder locally applied to the deep wound and subcutaneous layer prior to closure.
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.

No Intervention: Control - No vancomycin application
No intervention, control group All other wound closure procedure and wound care and monitoring are the same



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Serum vancomycin level [ Time Frame: Three days postoperatively ]
    3 days postoperative serum assessment of vancomycin levels to identify any vancomycin toxicity in serum

  3. Renal function test [ Time Frame: Three days postoperatively ]
    3 days postoperative serum assessment of renal function tests to identify any renal impairment



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03839914


Contacts
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Contact: Jason PY Cheung (852) 22554581 cheungjp@hku.hk

Locations
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Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong

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Responsible Party: Dr. Jason Pui Yin Cheung, Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03839914     History of Changes
Other Study ID Numbers: Study protocol 1.0
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Jason Pui Yin Cheung, The University of Hong Kong:
vancomycin powder
surgical site infection
open posterior spinal surgery
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents