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
|Condition or disease||Intervention/treatment||Phase|
|Spinal Degeneration Spinal Deformity Trauma Spinal Tumor Surgical Site Infection||Drug: Vancomycin powder||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||170 participants|
|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.|
|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|
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
- 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
- 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
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
|Contact: Jason PY Cheung||(852) firstname.lastname@example.org|
|Queen Mary Hospital|
|Hong Kong, Hong Kong|