Comparison of the perp of the surgical location with betadine 10% versus chlorhexidine gluconate 4% on the incidence rate and the severity of wound infection after upper limb orthopedic elective surgery: a double-blind randomized clinical trial
Comparison of the perp of the surgical location with betadine 10% versus chlorhexidine gluconate 4% on the incidence rate and the severity of wound infection after upper limb orthopedic elective surgery
Design
This is a randomized clinical trial, in which 140 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients who are a candidate for upper limb orthopedic elective surgery and will refer to Kosar Hospital in Sanandaj City during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the drawing of lots. This trial will be double-blinded so that neither patients nor the physician who will examine the patients will be aware of the intervention
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age range18 to 60 years old; candidate for upper limb orthopedic elective surgery; body mass index less than 30; normal white blood cell count.
Exclusion criteria:
open fracture; history of upper limb surgery; presence of scar on the upper limb; affected with infectious diseases; diabetes or vascular disorders; immunodeficiency; taking immunosuppressive drugs; using alcohol or smoking cigarette.
Intervention groups
Intervention group:
perp of the surgical location with chlorhexidine gluconate 4% for 3 minutes. Control group: perp of the surgical location with betadine 10% for 3 minutes.
Main outcome variables
The incidence rate of wound infection; the severity of wound infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N315
Registration date:2019-10-30, 1398/08/08
Registration timing:prospective
Last update:2019-10-30, 1398/08/08
Update count:0
Registration date
2019-10-30, 1398/08/08
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2021-07-03, 1400/04/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the perp of the surgical location with betadine 10% versus chlorhexidine gluconate 4% on the incidence rate and the severity of wound infection after upper limb orthopedic elective surgery: a double-blind randomized clinical trial
Public title
Comparison of the perp of the surgical location with betadine 10% versus chlorhexidine gluconate 4% on the incidence rate and the severity of wound infection after upper limb orthopedic elective surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age:18 to 60 years old
Candidate for upper limb orthopedic elective surgery
Body mass index less than 30
Normal white blood cell count
Exclusion criteria:
Open fracture
History of upper limb surgery
Presence of scar on the upper limb
Affected with infectious diseases
Diabetes or vascular disorders
Immunodeficiency
Taking immunosuppressive drugs
Using alcohol or smoking cigarette
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Sanadaj University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Sanadaj University of Medical Sciences, Pasdaran Ave
City
Sanandaj
Province
Kurdistan
Postal code
6617715175
Approval date
2019-07-01, 1398/04/10
Ethics committee reference number
IR.MUK.REC.1398.069
Health conditions studied
1
Description of health condition studied
Surgical wound infection
ICD-10 code
T81.4
ICD-10 code description
Infection following a procedure
Primary outcomes
1
Description
The incidence rate of wound infection
Timepoint
One week after surgery
Method of measurement
Thorough physical examination
2
Description
The severity of wound infection
Timepoint
One week after surgery
Method of measurement
By Asepsis index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Perp of the surgical location with chlorhexidine gluconate 4% for 3 minutes
Category
Treatment - Surgery
2
Description
Control group:Perp of the surgical location with betadine 10% for 3 minutes
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar Hospital in Sanandaj City
Full name of responsible person
Behzad Gholamveisi
Street address
Kosar Hospital, Bohanedin Hamdi Ave.
City
Sanandaj
Province
Kurdistan
Postal code
66617983476
Phone
+98 87 3361 1231
Email
behzad.gholamveisi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Dr Ebrahim Ghaderi
Street address
Sanadaj University of Medical Sciences, Pasdaran Ave
City
Sanadaj
Province
Kurdistan
Postal code
6617715175
Phone
+98 87 3366 4600
Email
info.research@muk.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Behzad Gholamveisi
Position
Master of Operating Room
Latest degree
Master
Other areas of specialty/work
General Surgery
Street address
School of Paramedicine, Sanadaj University of Medical Sciences, Pasdaran Ave.
City
Sanadaj
Province
Kurdistan
Postal code
6617715175
Phone
+98 87 3366 4600
Email
behzad.gholamveisi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Behzad Gholamveisi
Position
Master of Operating Room
Latest degree
Master
Other areas of specialty/work
General Surgery
Street address
School of Paramedicine, Sanadaj University of Medical Sciences, Pasdaran Ave.
City
Sanadaj
Province
Kurdistan
Postal code
6617715175
Phone
+98 87 3366 4600
Email
behzad.gholamveisi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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
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
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