Survey and comparison the effect of skin preparation with povidone-iodine, chlorhexidine and alcohol antiseptics on microbial counts of surgical site in abdominal surgery patients referring to selected hospitals of Iran University of Medical Sciences
Survey and comparison the effect of skin preparation with povidone-iodine, chlorhexidine and alcohol antiseptics on microbial counts of surgical site in abdominal surgery patients referring to selected hospitals of Iran University of Medical Sciences
Design
Three parallel groups with 40 patient in each group, double blind and randomized by lottery with proportional allocation
Settings and conduct
This study is a clinical trial study performed on abdominal surgery patients referred to selected hospitals of Iran University of Medical Sciences (Hazrat Rasoul and Firoozgar). The sample consisted of 120 patients with abdominal surgery who were randomly divided into three groups of 40 patients (3 subjects in each group and 360 subjects in total). For blinding, each sample was assigned a code and only the researcher knew that patient where in which group and the rest of the research team were not aware of this.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients undergoing elective abdominal surgery were at least 18 years of age. Exclusion criteria: Patients with a history of the following diseases: Inflammatory skin diseases - A history of allergies to alcohol, povidone iodine and chlorhexidine - Wounds or any visible skin lesions in the abdominal area - Prohibition on the use of disinfectants for perforation - Immune deficiency - Patients who use immunosuppressants.
Intervention groups
patients with elective abdominal surgery divided into three groups: Group I: Skin preparation with Povidone iodine 7/5% and Povidone iodine 10%; Group 2: Skin preparation with povidone iodine 7/5%, alcohol 70% and povidone iodine 10%; Group 3: Skin preparation with chlorhexidine in alcohol and povidone iodine 10%
Main outcome variables
Microbial counts of surgical site
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190821044575N1
Registration date:2019-11-07, 1398/08/16
Registration timing:retrospective
Last update:2019-11-07, 1398/08/16
Update count:0
Registration date
2019-11-07, 1398/08/16
Registrant information
Name
Hamed Taghiloo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3354 7131
Email address
taghiloo.h@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-14, 1397/11/25
Expected recruitment end date
2019-07-06, 1398/04/15
Actual recruitment start date
2019-03-16, 1397/12/25
Actual recruitment end date
2019-07-21, 1398/04/30
Trial completion date
2019-07-21, 1398/04/30
Scientific title
Survey and comparison the effect of skin preparation with povidone-iodine, chlorhexidine and alcohol antiseptics on microbial counts of surgical site in abdominal surgery patients referring to selected hospitals of Iran University of Medical Sciences
Public title
Evaluation and comparison of Povidone iodine, Chlorhexidine and alcohol on microbial count
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing elective abdominal surgery
Being at least 18 years old
Exclusion criteria:
Inflammatory skin diseases
Having a history of alcohol , povidone iodine and chlorhexidine allergies
Wounds or any visible skin lesions in the abdominal area
Prohibition on the use of disinfectants for skin prep
Patients with Immune Deficiency
Patients taking immunosuppressive drugs.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
120
Actual sample size reached:
120
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
For blinding, each of the samples taken from the patients was coded for blindness, and only the researcher knew in which group the individual was located and the rest of the research team was unaware of this.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences,Next to Milad Tower; Hemmat Highway,Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2019-02-14, 1397/11/25
Ethics committee reference number
IR.IUMS.REC.1397.1125
Health conditions studied
1
Description of health condition studied
Selective abdominal surgery patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Microbial count rate
Timepoint
Cultures were taken before skin preparation, after primary skin preparation and after secondary skin preparation.
Method of measurement
Data collection tools included demographic data form and number and type of colonies of microorganisms
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group 1: Before the intervention, a microbial culture was harvested from the skin of the surgical site then Primary skin preparation with povidone-iodine7.5% antiseptic was carried out for 5 minutes. After antiseptic drying, microbial culture was harvested. Secondary skin preparation was performed with povidone-iodine 10% antiseptic for 2 minutes and after drying this antiseptic the third culture sample was taken.
Category
Prevention
2
Description
Intervention Group 2: Before the intervention, a microbial culture was harvested from the skin of surgical site then Primary skin preparation with povidone-iodine7.5% antiseptic was carried out for five minutes and then After drying it skin prep with alcohol performed for one minute and after antiseptic drying, microbial culture was harvested. Secondary skin preparation was performed with povidone-iodine 10% antiseptic for two minutes and after drying this antiseptic the third culture sample was taken.
Category
Prevention
3
Description
Intervention Group 3: Before the intervention, a microbial culture was harvested from the skin of the surgical site then Primary skin preparation with chlorhexidine2% in alcohol70% antiseptic was carried out for two minutes then after antiseptic drying, microbial culture was harvested. Secondary skin preparation was performed with povidone-iodine 10% antiseptic for two minutes and after drying this antiseptic the third culture sample was taken
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Rasoul Akram hospital and Firouzgar hospital