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Evaluating the Efficacy and Safety of Intra-wound Vancomycin Powder in High Risk Patients

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03839914
Recruitment Status : Not yet recruiting
First Posted : February 15, 2019
Last Update Posted : October 30, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Jason Pui Yin Cheung, The University of Hong Kong

Brief Summary:
Surgical site infections (SSI) 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 Deformity Trauma Spinal Tumor Surgical Site Infection Drug: Vancomycin powder Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 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: Randomized, Controlled, Single-blinded Trial to Evaluate the Efficacy and Safety of Intra-wound Administration of Vancomycin Powder as Add-on Prophylactic Intraoperative Antibiotic in Patients at High Risk for Surgical Site Infections After Receiving 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. Incidence of superficial incisional SSI [ Time Frame: one year ]

    CDC Surgical Site Infection Criteria (Centers for Disease Control, Procedure-associated Module SSI, January 2019)

    The definition of SSSI is:

    1. an infection occurs within 30 days after operation (where day 1= operation day);

      AND

    2. Involves only skin/subcutaneous tissue of the incision;

    AND

    3) Patient has at least one of the following: a)purulent drainage from the superficial incision; b)organism(s) identified from an aseptically-obtained specimen from the superficial incision or subcutaneous tissue by a culture/non-culture based microbiologic testing method; c)superficial incision being deliberately opened by a surgeon, attending doctor/other designee and culture/non-culture based testing of the superficial incision or subcutaneous tissue is not performed AND Patient has at least one of the following: localized pain/tenderness, localized swelling, erythema, or heat; d) SSSI diagnosed by a surgeon, attending doctor/other designee.


  2. Incidence of deep incisional SSI [ Time Frame: one year ]

    Deep Incisional SSI (DSSI)

    1. For deep incisional SSI, the definition is an infection occurring within 90 days after the operation (where day 1 = the procedure day); AND
    2. Involves deep soft tissues of the incision (e.g. fascial and muscle layers); AND
    3. Patient has at least one of the following:

      1. purulent drainage from the deep incision;
      2. a deep incision spontaneously dehisces, or is deliberately opened or aspirated by the surgeon, attending doctor or other designee;

        AND

        Organism(s) identified from the deep soft tissues of the incision by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment;

        AND

        Patient has at least one of the following signs and symptoms: fever (>38 °C); localized pain or tenderness;

      3. An abscess or other evidence of infection involving the deep incision that is detected on gross anatomical or histopathologic exam, or imaging test.

  3. Number of participants with adverse event (AE) to vancomycin [ Time Frame: one year ]

    An AE is any untoward medical occurrence to a patient which does not necessarily has a causal relationship with the study intervention, and it can also occur outside of the time period. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), new or exacerbated symptoms/diseases temporally associated with the study intervention, whether or not the event is considered causally related to the use of intervention. Medical conditions/diseases present before the study intervention are only considered as AEs if they worsen after intervention. Signs and symptoms that are clearly due to natural process of underlying disease/disease progression should not be reported. SSSI/DSSI is not regarded as an AE in the study. Secondary infection of a SSSI/DSSI or other infection shall be regarded as an AE.

    The term AE is used to include both serious and non-serious AE.



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. Incremental cost-effectiveness ratio [ Time Frame: one year ]
    It is the incremental cost divided by the difference in the number of SSI cases between treatment group and control group over a 1-year post-operative period.

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

  4. 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:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female or male adult with age ≥18 years
  2. Undergoing open posterior spinal surgery with instrumentation indicated for spinal deformity, trauma and tumor
  3. Able to understand the nature, scope and possible consequences of participation in the study
  4. Appropriate voluntary written informed consent have been provided by patients

Exclusion Criteria:

  1. Has been treated with antibiotics due to primary spinal infection (i.e. spondylodiscitis) within 1 year prior to surgery
  2. Ongoing treatment with antibiotics for other infections
  3. Undergoing minimally invasive surgery or anterior-only surgical approaches or deformity correction surgery for adolescent idiopathic scoliosis (inherent low-risk for surgical site infections18)
  4. Undergoing decompression-only surgery for cervical spine, spinal deformity, trauma and tumors
  5. Has known history of allergy to vancomycin, penicillin and other glycopeptides (teicoplanin)
  6. Has history of vancomycin resistance
  7. Pregnancy

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    
Other Study ID Numbers: Study protocol 1.4
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: October 30, 2019
Last Verified: October 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
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents