Comparison of the rate of infection at the surgical site in case of using the sterile drape and not using it in spinal surgeries
Design
A randomized controlled clinical trial with parallel groups, double-blind, phase 2-3, was conducted on 184 patients, using block randomization for randomization."
Settings and conduct
This controlled clinical trial is being conducted at Besat Hospital in Hamadan in the year 2024. The occurrence of surgical wound infection is compared between two study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Non-traumatic patients needing spine surgery
Exclusion criteria: Loss of patients during follow-up; Previous history of spine infection; History of immunodeficiency or ongoing chemotherapy
Intervention groups
In the intervention group, after a two-stage preparation process involving one application of 7.5% povidone-iodine followed by a subsequent application of 10% povidone-iodine, the surgical site is sterilized. Then, a sterile cloth drape is fixed over the surgical site after it has dried, and the surgery is performed. However, in the control group, a plastic drape is not used for covering the surgical site.
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:IRCT20160523028008N32
Registration date:2024-07-10, 1403/04/20
Registration timing:prospective
Last update:2024-07-10, 1403/04/20
Update count:0
Registration date
2024-07-10, 1403/04/20
Registrant information
Name
Mohammad Faryadras
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3428 9706
Email address
m.faryadras@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-21, 1403/04/31
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the rate of infection at the surgical site in case of using the sterile drape and not using it in spinal surgeries
Public title
The rate of infection at the surgical site in case of using the sterile drape and not using it in spinal surgeries
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Non-traumatic patients needing spine surgery
Exclusion criteria:
Loss of patients during follow-up
Previous history of spine infection
History of immunodeficiency or ongoing chemotherapy
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
184
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached
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
Research Ethic Committee of Hamadan University of Medical Science
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2023-08-02, 1402/05/11
Ethics committee reference number
IR.UMSHA.REC.1402.726
Health conditions studied
1
Description of health condition studied
Infection and inflammatory reaction due to internal fixation device [any site]
ICD-10 code
T84.60
ICD-10 code description
Infection and inflammatory reaction due to internal fixation device of unspecified site
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: After prepping in two stages, once with 7.5% povidone-iodine and again with 10% povidone-iodine, the area is sterilized. Then, a sterile cloth drape is placed, followed by securing a plastic drape over the surgical site before performing the surgery.
Category
Prevention
2
Description
Control group: After prepping in two stages, once with 7.5% povidone-iodine and again with 10% povidone-iodine, the area is sterilized. A cloth drape is fixed over the surgical site, and the surgery is performed.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Mohammad Reza Saatian
Street address
Hamedan-Fatemi Blvd.
City
Hamadan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3265 0030
Email
mrsaatian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokohei
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh street
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
vc_research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Ghaleeie
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Hamedan-Fatemi Blvd.
City
Hamadan
Province
Hamadan
Postal code
6517838677
Phone
+98 918 852 9290
Email
M_ghaleie@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
mohammad
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Hamedan-Fatemi Blvd.
City
Hamadan
Province
Hamadan
Postal code
6517838677
Phone
+98 918 852 9290
Email
M_ghaleie@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
mohammad
Position
Assistant Professor of Neurosurgery
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Hamedan-Fatemi Blvd.
City
Hamadan
Province
Hormozgan
Postal code
6517838677
Phone
+98 81 3265 0030
Email
mrsaatian@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD