Evaluating the Efficacy and Safety of Intra-wound Vancomycin Powder in High Risk Patients
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|ClinicalTrials.gov Identifier: NCT03839914|
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : November 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Spinal Deformity Trauma Spinal Tumor Surgical Site Infection||Drug: Vancomycin powder||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||76 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:||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|
|Actual Study Start Date :||August 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
- 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:
an infection occurs within 30 days after operation (where day 1= operation day);
- Involves only skin/subcutaneous tissue of the incision;
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.
- Incidence of deep incisional SSI [ Time Frame: one year ]
Deep Incisional SSI (DSSI)
- For deep incisional SSI, the definition is an infection occurring within 90 days after the operation (where day 1 = the procedure day); AND
- Involves deep soft tissues of the incision (e.g. fascial and muscle layers); AND
Patient has at least one of the following:
- purulent drainage from the deep incision;
a deep incision spontaneously dehisces, or is deliberately opened or aspirated by the surgeon, attending doctor or other designee;
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;
Patient has at least one of the following signs and symptoms: fever (>38 °C); localized pain or tenderness;
- An abscess or other evidence of infection involving the deep incision that is detected on gross anatomical or histopathologic exam, or imaging test.
- 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.
- 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
- 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.
- 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) email@example.com|
|Queen Mary Hospital||Recruiting|
|Hong Kong, Hong Kong|
|Contact: Prudence Cheung firstname.lastname@example.org|