Unique ID issued by UMIN | UMIN000009377 |
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Receipt number | R000010952 |
Scientific Title | To Sprinkle Vancomycin Powder or Ampicillin into Operative Field Decrease Severe Surgical Site Infection in Thoracolumbar Fusions. Double blind prospective RCT |
Date of disclosure of the study information | 2012/11/22 |
Last modified on | 2019/05/28 10:29:59 |
To Sprinkle Vancomycin Powder or Ampicillin into Operative Field Decrease Severe Surgical Site Infection in Thoracolumbar Fusions. Double blind prospective RCT
Sprinkling Vancomycin or Ampicillin Powder into Operative Field.
To Sprinkle Vancomycin Powder or Ampicillin into Operative Field Decrease Severe Surgical Site Infection in Thoracolumbar Fusions. Double blind prospective RCT
Sprinkling Vancomycin or Ampicillin Powder into Operative Field.
Japan |
Patients undergoing thoracolumbar fusion surgery
Orthopedics | Neurosurgery |
Others
NO
Is it possible to decrease severe post surgical site severe infection by using Vancomycin powder?
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Surgical site infection (SSI) within one year after the surgery based on the international SSI definition.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
2
Prevention
Medicine |
Sprinkling Vancomycin Powder into Operative Field and bone tips after Thoracolumbar fusion surgery.
Sprinkling Ampicillin Powder into Operative Field and bone tips after Thoracolumbar fusion surgery.
Not applicable |
Not applicable |
Male and Female
All Patients undergoing thoracolumbar fusion surgery.
1. The patients with putting the drainage more than three days after the fusion surgery.
2. The patients with performing antibiotic DIV more than four days after the fusion surgery.
3. The patients with allergy for Vancomycin and Ampicillin.
200
1st name | Mikinobu |
Middle name | |
Last name | Takeuchi |
Aichi Medical University
Spine Center
480-1195
1-1, Karimata Yazako Nagakute City Aichi
0561-62-3311
neuromicky@gmail.com
1st name | Mikinobu |
Middle name | |
Last name | Takeuchi |
Aichi Medical University
Spine Center
480-1195
1-1, Karimata Yazako Nagakute City Aichi
0561-62-3311
neuromicky@hotmail.com
Aichi Medical University
general incorporation foundation Aikeikai
Non profit foundation
Aichi Medical University
1-1, Karimata, yazako, Nagakute City, Japan
0561-62-3311
syomu@aichi-med-u.ac.jp
NO
愛知医科大学病院
2012 | Year | 11 | Month | 22 | Day |
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000010952&ty
Published
J Neurosurg Spine. 2018 Nov 1;29(5):553-559. doi: 10.3171/2018.3.SPINE171111.
265
The trial was prematurely stopped according to predetermined rules. The results showed one superficial infection (0.9%, Staphylococcus aureus) and one deep infection (0.9%, S. aureus) in the VCM group and two superficial infections (1.8%, Staphylococcus epidermidis and culture negative) and one deep infection (0.9%, methicillin-resistant S. aureus) in the AMP group. No significant differences in infection rates were observed between the groups (p = 0.8).
2019 | Year | 05 | Month | 28 | Day |
The two groups did not significantly differ with respect to age, blood loss, operative time, number of fusion levels, dia- betes status, smoking habits, BMI, previous thoracic and/ or lumbar surgery, steroid use, presence of trauma, or pre- operative JOABPEQ scores, although they did differ in terms of patient sex (p = 0.04).
The criteria for inclusion were subjects undergoing tho- racic and/or lumbar fusion surgery. The exclusion criteria were allergies to VCM or AMP.
None
The primary endpoint was the observation of deep or superficial SSI within 1 year of surgery.
Main results already published
2012 | Year | 10 | Month | 15 | Day |
2012 | Year | 11 | Month | 22 | Day |
2012 | Year | 11 | Month | 22 | Day |
2015 | Year | 12 | Month | 31 | Day |
2015 | Year | 12 | Month | 31 | Day |
2012 | Year | 11 | Month | 21 | Day |
2019 | Year | 05 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010952
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