The effect of applying local vancomycin in reducing the rate of postoperative infection in spinal surgeries
Design
Clinical trial with control group, with parallel groups, one-way blind, randomized, phase 3 on 360 patients. The web was used for randomization.
Settings and conduct
In the control group, sutures were routinely applied in 3 layers of fascia, subcutaneous and cutaneous skin. After washing the wound site in the treatment group, in cases up to 2 levels of spine surgery, 1 gram, and in cases more than 2 levels, 2 grams of vancomycin were used. The antibiotic powder was poured on muscles, bones, and subcutaneous tissue, but not on the dura and fusion site.
Participants/Inclusion and exclusion criteria
Inclusion criteria included all patients over 18 years of age who underwent open spinal surgery in the cervical, thoracic and lumbosacral regions
Exclusion criteria included the following: 1.Previous history of spine infection 2. History of immunodeficiency or ongoing chemotherapy 3. History of kidney or liver failure 4. Allergy to vancomycin or cephalosporin 5. Inability to follow up to 3 months after surgery 6.primary or metastatic spinal cord or spine tumors 7. Dissatisfaction with the study.
Intervention groups
Application of topical vancomycin powder at the site of surgical incision on fascia, muscles and subcutaneous tissue after surgery and before closing the surgical site in the intervention group,No drug or placebo is used in the control group
Main outcome variables
Surgical site infections
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210712051848N1
Registration date:2021-08-13, 1400/05/22
Registration timing:retrospective
Last update:2021-08-13, 1400/05/22
Update count:0
Registration date
2021-08-13, 1400/05/22
Registrant information
Name
Hamid Reza Khayat Kashani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7343 0000
Email address
khayatkashani@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-01, 1398/06/10
Expected recruitment end date
2020-09-10, 1399/06/20
Actual recruitment start date
2019-09-09, 1398/06/18
Actual recruitment end date
2020-08-01, 1399/05/11
Trial completion date
2020-11-20, 1399/08/30
Scientific title
Local Vancomycin Therapy to Reduce Surgical Site Infection in Spine Surgery: A Randomized Prospective Study
Public title
The efficacy of local vancomycin on postoperative infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients over 18 years of age who underwent open spinal surgery in the cervical, thoracic and lumbosacral regions
Exclusion criteria:
Previous history of spine infection
History of immunodeficiency or ongoing chemotherapy
History of kidney or liver failure
Allergy to vancomycin or cephalosporin
Inability to follow up to 3 months after surgery
Primary or metastatic spinal cord or spine tumors
Dissatisfaction with the study.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
360
Actual sample size reached:
370
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, the web-based randomization method is used. The individual randomization unit is a sealed envelope randomization tool, and the samples are randomly divided into 2 groups with equal numbers. www.Randomization.com is used to random allocation. The method of Sequentially numbered, sealed, opaque envelopes is used for allocation concealment
Blinding (investigator's opinion)
Single blinded
Blinding description
The patient participating in the study is not aware of her/his group and due to the fact that vancomycin powder is used under anesthesia, there is no need to use a placebo.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Medical School, Shahid Beheshti University of Medical Sciences
Street address
School of Medicine, Shahid Beheshti University of Medical Sciences, Koodkiar St., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-08-27, 1398/06/05
Ethics committee reference number
IR.SBMU.MSP.REC.1398.494
Health conditions studied
1
Description of health condition studied
Surgical site infections
ICD-10 code
T84.6
ICD-10 code description
Infection and inflammatory reaction due to internal fixation device [any site]
Primary outcomes
1
Description
Discharge from the wound
Timepoint
The wound site is examined at the time of discharge, two weeks after surgery, and 3 months after surgery
Method of measurement
Physical examination and history
2
Description
Swelling of the operation site
Timepoint
The wound site is examined at the time of discharge, two weeks after surgery, and 3 months after surgery
Method of measurement
Physical examination and history
3
Description
Redness of the operation site
Timepoint
The wound site is examined at the time of discharge, two weeks after surgery, and 3 months after surgery
Method of measurement
Physical examination and history
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: after surgery and irrigation with normal saline, vancomycin powder is used locally in the intervention group. If the level to be operated is one level, one gram is used and if it is more than one level, two grams of vancomycin are used. The vancomycin used is made by Exir Pharmaceutical Company and it is used on muscles, subcutaneous tissue and fascia. The skin and fascia are then repaired.
Category
Treatment - Drugs
2
Description
Local drug or placebo is not used. After surgery, the operation site is irrigated with normal saline and the fascia, muscles and skin are closed in several layers.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hosein Hospital
Full name of responsible person
Hamid Reza Khayat Kashani
Street address
Madani Street
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Fax
+98 21 7755 7069
Email
hrkhka@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zargi
Street address
Shahid Beheshti University of Medical Sciences, Shahid Arabi St., Next to Ayatollah Taleghani Hospital, Yemen St., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 2233
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Yes - There is 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
The study data is shared at the request of researchers after deleting personal details and identifying individuals
When the data will become available and for how long
Access to data starts from the time the results are published.
To whom data/document is available
Data will be sent to all researchers who request it
Under which criteria data/document could be used
The use of the requested data for meta-analysis is permitted in systematic review studies
From where data/document is obtainable
Researchers can contact Dr. Hamid Reza Khayat Kashani for the data in the following ways:Email: hrkhka@gmail.com
Tel: 00989131625625
Address: Neurosurgery Department,Imam Hosein Hospital, Madani Street, Tehran, Iran
What processes are involved for a request to access data/document
After the researcher's request to receive the data, it is referred to the research deputy of the neurosurgery department, and after reviewing the researcher's profile and his request on how to use the data, if agreed, the data will be sent to him or her. Otherwise, he/she will be informed of the reason for not sending the data, and this process will take less than a month.