Effects of preoperative use of povidone iodine-impregnated dressing on postoperative rate of surgical site infection in patients undergoing posterior lumbar spinal fusion surgery
This study aims to evaluate the effects of preoperative use of povidone iodine-impregnated dressing on postoperative rate of surgical site infection in patients undergoing posterior lumbar spinal fusion surgery.
Design
This study is a two-arm, parallel-group, open-label, randomized controlled trial, including 160 patients undergoing posterior spinal fusion surgery.
Settings and conduct
Given the nature of the study intervention, no blinding will be performed. This study will be performed in neurosurgery department of Shohada Tajrish hospital.
Participants/Inclusion and exclusion criteria
Patients undergoing posterior spinal fusion surgery will be included in this clinical trial. Patients with prior history of hypersensitivity reaction to study drug, active or history of spinal infection, and intradural spinal pathology will be excluded from the study.
Intervention groups
Patients will be randomly divided into two groups, including intervention and control. Patients in the intervention group will receive a sterile gauze soaked in 10% povidone iodine solution 12 hours before the operation, which will be placed over the anticipated incision site. Patients in the control group will receive no placebo and undergo standard perioperative care.
Main outcome variables
The primary outcome measure of the study will be the incidence of surgical site infection during the postoperative 30 days.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200502047277N10
Registration date:2022-10-03, 1401/07/11
Registration timing:registered_while_recruiting
Last update:2022-10-03, 1401/07/11
Update count:0
Registration date
2022-10-03, 1401/07/11
Registrant information
Name
saeed oraee yazdani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 25719
Email address
saeed_o_yazdani@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of preoperative use of povidone iodine-impregnated dressing on postoperative rate of surgical site infection in patients undergoing posterior lumbar spinal fusion surgery
Public title
Povidone iodine-impregnated dressing and surgical site infection in spine surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing posterior lumbar spinal fusion surgery
Written informed consent
Exclusion criteria:
Prior hypersensitivity reaction to study drug
Active or history of spinal infection
Intradural spinal pathology
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization (1:1) with a block size of 4 will be performed using the SPSS 24, and sealed opaque envelopes will be used for allocation concealment. In SPSS, after dividing the study population into blocks, random numbers between 0 and 1 will be generated for each patient using RV.UNIFORM(0,1) and after determining the rank within each block, the two lower ranks will be assigned to treatment group 1, and the two upper ranks will be assigned to treatment group 2. Except for the surgeon performing the study intervention, patients, principal investigator, outcome assessors, and data analyzers will remain blind to the randomization and allocation.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences ,Shahid Arabi St., Yemen St., Shahid Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2022-04-24, 1401/02/04
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.043
Health conditions studied
1
Description of health condition studied
Infection following a procedure
ICD-10 code
T81.4
ICD-10 code description
Infection following a procedure
2
Description of health condition studied
Fusion of spine
ICD-10 code
M43.2
ICD-10 code description
Fusion of spine
Primary outcomes
1
Description
Incidence of surgical site infection
Timepoint
During the first postoperative 30 days, including daily during the hospitalization and weekly after discharge
Method of measurement
Physical examination (during the hospitalization) and telephone call (after discharge)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in the study intervention group will receive a sterile gauze soaked in povidone iodine 10% solution, which will be placed over the anticipated incision site 12 hours before the operation.
Category
Prevention
2
Description
Control group: Patients in the control group will receive the standard preoperative care with no placebo.