The site of infection is one of the most commonly reported postoperative cases. The purpose of this study was to evaluate the effect of topical vancomycin powder on the prevention of local infection site infection in spinal surgery.
Design
This is a blind double blind clinical trial performed in Imam Khomeini hospital in Sari. Considering the 95% confidence level and 90% probability of testing, 100 patients were assigned to each group. Eligible patients are assigned to two groups using random numbers and based on their sample size
Settings and conduct
This is a double blind clinical trial that will be conducted to evaluate the effect of topical venecomycin powder on the prevention of site infections in posterior posterior spinal surgery in Imam Khomeini Hospital, Sari.After selecting the samples, the patients were randomly assigned to the two groups by randomization. One group received vancomycin and the control group who received only prophylaxis (intravenous only intravenous cesophageal) and another evaluated the surgical site.
Participants/Inclusion and exclusion criteria
Inclusion :Patients admitted to the neurological surgery department due to lumbar spinal cord stenosis, vertebral instability, DJD changes, and spinal trauma are candidates for surgical decompression of the spinal cord channel or spinal fusion.
Exit : Dora rupture during surgery - Revision action- Age under 18 and over 85 years - Chronic renal failure- Use of cortico steroids and immuno suppressive drugs --Diabetes mellitus
Intervention groups
Prevention and control of infection site by using vancomycin powder in the surgical site.
Main outcome variables
Infection of the site of surgery, including the secretion of the ulcer and the secretion of the site of surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180826040869N1
Registration date:2018-09-25, 1397/07/03
Registration timing:retrospective
Last update:2018-09-25, 1397/07/03
Update count:0
Registration date
2018-09-25, 1397/07/03
Registrant information
Name
Misagh Shafizad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 1700
Email address
mi.shafizad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-06-08, 1395/03/19
Expected recruitment end date
2017-06-09, 1396/03/19
Actual recruitment start date
2016-06-13, 1395/03/24
Actual recruitment end date
2017-07-08, 1396/04/17
Trial completion date
2017-07-08, 1396/04/17
Scientific title
The effectiveness of local vancomycin powder in the prevention of surgical site infections in posterior spinal surgeries
Public title
The effectiveness of local vancomycin powder in the prevention of surgical site infections in posterior spinal surgeries
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Spinal cord stenosis
Vertical instability
DJD changes
Spinal trauma
Age between 18 and 85 years
Exclusion criteria:
Dora tear during surgery
Revision operation
Age under 18 and over 85 years
Chronic renal failure
Taking corticosteroids and immunosuppressive drugs
Diabetes mellitus
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
200
Actual sample size reached:
200
Randomization (investigator's opinion)
Randomized
Randomization description
The referral who will be admitted to the study will be selected based on Comorbid conditions, including the presence or absence of diabetes, and the timing of the matching procedure. Each person is given a code and using the table. Random numbers are divided into two groups of 100 on the conditions of comorbid conditions including the presence or absence of diabetes and the time of matching surgery ) Takes place
Blinding (investigator's opinion)
Double blinded
Blinding description
After selecting the samples, the patients were randomly assigned to the two groups by randomization. One group received vancomycin and the control group who received only prophylaxis (intravenous only intravenous cesophageal) and another evaluated the surgical site.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Amir mazandrani Blvd sari Town
City
Sari
Province
Mazandaran
Postal code
4816633131
Approval date
2016-10-06, 1395/07/15
Ethics committee reference number
IR.MAZUMS.REC.1395.2175
Health conditions studied
1
Description of health condition studied
Lumbar spinal cord stenosis- vertebral instability- DJD changes- -spinal trauma candidates candidate- surgery for decompression of the spinal cord - spinal fusion
ICD-10 code
M99.3
ICD-10 code description
Osseous stenosis of neural canal
Primary outcomes
1
Description
Percentage of people who have a surgical wound infection
Timepoint
Patients will be screened for infection two weeks, one month and two months after surgery.
Method of measurement
An infection site of the surgery, including the secretion and opening of the wound, from the cultures of the site of the operation to confirm the presence of the infection will be used. The ESR test also has a positive CRP.wound, will be used to determine the presence of the infection.
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, on the day of preoperative surgery, one gram of intravenous cefazolin is used at the end of the surgery before closing the wound with 1 g of vancomycin powder locally in the wounds below 10 cm and 5.1 g for wounds greater than 10 cm. All Patients will be screened again for two weeks, one month and two months after the operation, and the condition of the wound will be investigated for infection. In cases of suspected surgery site infection, including the secretion and opening of the wound, the cultures of the site will be used to confirm the presence of the infection. ESR and CRP are also checked.
Category
Treatment - Drugs
2
Description
Control group: In the control group, only the patient will receive an antibiotic prophylaxis (1 g of venous cefazolin) before surgery, and as an interventional surgical wound for two weeks, one and two months later, the infection will be monitored.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hospital
Full name of responsible person
Misagh Shafizad
Street address
Amir Mazandarani Blvd ,Sari Town
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
mi.shafizad@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeidi
Street address
Moalem Blvd., Sari Town
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷-۳۳۹۷۱
Phone
+98 11 3448 4854
Fax
+98 11 3335 2725
Email
saedi@domian.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Misagh Shafizad
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Amir Mazandrani Blvd, Sari Town
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
mi.shafizad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Misagh Shafizad
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Amir Mazandarani Blvd ,Sari Town
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
mi.shafizad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Misagh Shafizad
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Amir Mazandarani Blvd ,Sari Town
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
mi.shafizad@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
-
When the data will become available and for how long
-
To whom data/document is available
-
Under which criteria data/document could be used
-
From where data/document is obtainable
--
What processes are involved for a request to access data/document