Comparison study of antibacterial effectiveness of Betadine-alcohol, Decosept, septicidin and Sterillium for surgical hand anticepcis on hand bacterial flora
Objective: to compare antibacterial effect of 4 surgical hand antiseptics (Betadine- ethyl alcohol 70%, Decosept, Septicidin and Sterillium) on hand bacterial flora
Design: before and after clinical trial.
Setting: 20 healthy volunteers aged>18 years old.
Inclusion criteria: healthy volunteers whose nails were short and clean, and didn’t use any substances or soap with antimicrobial activity for one week before testing.
Exclusion criteria: pregnant women; presence of any cuts or abrasion on hand skin; any skin disorders.
Interventions and primary and secondary outcome: before treatment volunteers washed their hand with 10 ml of a soft soap for 1 minute. After rinsing and drying bacterial culture samples of both hands were taken according to EN12791. In each intervention immediately after sampling for prevalues, subjects rubbed their hand with one of 4 products under test (Betadine- ethyl alcohol 70%, Decosept, Septicidin and Sterillium ). For evaluating efficacy of any disinfecting agent, according to EN1279, has to compare with that of reference disinfectant (propan-1-ol 60%), that is applied for 3 min; therefore volunteers rubbed their hands with reference alcohol too. After disinfecting to assess the immediate antimicrobial effect a sample as well as pervalue was taken from one random selected hand, unsampled hand was gloved for 3 hours. For the assessment of sustained effect after removing of glove sampling was done as the immediate effect. All bacterial samples were incubated for 24-48h at 37℃∓1℃ . Between each treatment at least one week had to elapse to allow regrowth of normal skin flora.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013041513017N1
Registration date:2013-05-22, 1392/03/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-05-22, 1392/03/01
Registrant information
Name
Mitra Zandiyeh
Name of organization / entity
Hamadan medical Sciences university, Paramedical schol
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 1037
Email address
zandyeh@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor of research, Hamadan University of Medical Sciences
Expected recruitment start date
2012-06-02, 1391/03/13
Expected recruitment end date
2012-10-01, 1391/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison study of antibacterial effectiveness of Betadine-alcohol, Decosept, septicidin and Sterillium for surgical hand anticepcis on hand bacterial flora
Public title
Antibacterial effectiveness of Betadine- alcohol, Decosept, septicidin and Sterillium on hand bacterial flora
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: healthy volunteers whose nails were short and clean, and didn’t use any substances with antibacterial activity or antibacterial soap for one week before testing
Exclusion criteria: pregnant women; presence of any cuts or abrasion on hand skin; any skin disorders.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
local human subject review boardo, vice chancellor of research technology, Hamadan university of med
Street address
Hamadan university of medical sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838736
Approval date
2012-05-14, 1391/02/25
Ethics committee reference number
3046/9/35/16/د/پ
Health conditions studied
1
Description of health condition studied
topical agent
ICD-10 code
Y56.9
ICD-10 code description
Topical agent, unspecified
Primary outcomes
1
Description
Prevalue of microbial culture count
Timepoint
After hand washing with soft soap ( befor treatment with each product under test)
Method of measurement
Fingertrips of each hand for min rub on the base of a petri dish containing 10ml of TSB. dilution of 10-1 and 10-2 of these sampling fluids preapered in TSB . for each dilution 0,1 ml is spread over the surface of a TSA plate. the plates were incubated at 37℃∓1℃ for 24-48h. Finally the cfu/ml were reported
2
Description
Immediate postvalue microbial culture count
Timepoint
Immediately after treatment with products under test
Method of measurement
As well as prevalue microbial culture count , from one hand that was selected randomly
Secondary outcomes
1
Description
Three hours post value microbial culture count
Timepoint
Three hours after disinfection by product under test
Method of measurement
As well as immediate post value microbial culture count , but sample was obtained from another hand( was gloved )
Intervention groups
1
Description
Intervention1( treatment with Betadin scrub 7.5%- ethyl alcohol 70%): In accordance with EN12791 before each intervention with every surgical hand disinfectant product under test, volunteers must wash both hands with 10ml soft soap( soap kalinus ) for 1min, then rinsed with running tap water, subsequently hands were dried with paper towels. After providing prevalue bacterial culture samples, at first subjects wet their hands with tap water, then hands were washed up to wrist in 2, 1.5 min steps as same as EN12791 hand rub technique. In each step 2-3ml betadin was applied. After surgical hand antisepsis, hands were rinsed with tap water for 15 seconds and dried with sterile gauze. Immediately after that, hands were rubbed with 2-3ml ethyl alcohol 70% as hands were kept wet for 1min.
Thereupon ; a microbial culture count sample was taken from one randomly selected hand, next another hand was put on sterile glove for 3 hour. From this hand after 3 h, a microbial culture count sample was taken (3 h).
Category
Treatment - Drugs
2
Description
Intervention2(treatment with Decosept): In accordance with EN12791 before each intervention with every surgical hand disinfectant product under test, volunteers must wash both hands with 10ml soft soap( soap kalinus ) for 1min, then rinsed with running tap water, subsequently hands were dried with paper towels. After providing prevalue bacterial culture samples, all volunteers disinfected their both hands up to wrist in accordance with EN12791 and standard hand rub procedure with 8-12ml Decosept for 3min. if hands nearly dried, additional volume of product were applied so hands were being kept wet during disinfection period.
Thereupon a microbial culture count sample was taken from one randomly selected hand, next another hand was put on sterile glove for 3 hour. From this hand after 3 h, a microbial culture count sample was taken (3 h).
Category
Treatment - Drugs
3
Description
Intervention3(treatment with Septicidin): In accordance with EN12791 before each intervention with every surgical hand disinfectant product under test, volunteers must wash both hands with 10ml soft soap( soap kalinus ) for 1min, then rinsed with running tap water, subsequently hands were dried with paper towels. After providing prevalue bacterial culture samples, all volunteers rubbed their both hands up to wrist in accordance with EN12791 and standard hand rub procedure with 10-14ml Septicidin for 6min. as soon as the hands were dried, additional volume of product was used to keep the hands moist while allocate time finished. Thereupon a microbial culture count sample was taken from one randomly selected hand, next another hand was put on sterile glove for 3 hour. From this hand after 3 h, a microbial culture count sample was taken (3 h).
Category
Treatment - Drugs
4
Description
Intervention4(treatment with Sterillium): In accordance with EN12791 before each intervention with every surgical hand disinfectant product under test, volunteers must wash both hands with 10ml soft soap( soap kalinus ) for 1min, then rinsed with running tap water, subsequently hands were dried with paper towels. After providing prevalue bacterial culture samples, all volunteers disinfected their both hands up to wrist in accordance with EN12791 and standard hand rub procedure with 4-7ml Sterillium for 3min. if hands nearly dried, additional volume of product were applied so hands were being kept wet during disinfection period. Thereupon a microbial culture count sample was taken from one randomly selected hand, next another hand was put on sterile glove for 3 hour. From this hand after 3 h, a microbial culture count sample was taken (3 h).
Category
Treatment - Drugs
5
Description
Intervention5(treatment with reference surgical hand disinfection: Propan- 1- ol 60%): In accordance with EN12791 before each intervention with every surgical hand disinfectant product under test, volunteers must wash both hands with 10ml soft soap( soap kalinus ) for 1min, then rinsed with running tap water, subsequently hands were dried with paper towels. After providing prevalue bacterial culture samples, all volunteers disinfected their both hands up to wrist in accordance with EN12791 and standard hand rub procedure with 6-12ml propan-1-ol 60% for 3min. If hands nearly dried, additional volume of product was applied so hands were being kept wet during disinfection period.Thereupon a microbial culture count sample was taken from one randomly selected hand, next another hand was put on sterile glove for 3 hour. From this hand after 3 h, a microbial culture count sample was taken (3 h).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Microbiological laboratory of Hamadan university of medical sciences
Full name of responsible person
Mitra Zandiyeh
Street address
Shahid Fahmideh Paramedical faculty - Hamadan university of medical sciences
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice chancellor for researchو Hamadan University of Medical Sciences
Full name of responsible person
Dr Heidar Tavilani
Street address
vice chancellor for research the Technology, Hamadan university of medical sciences,Shahid Fahmideh Ave, Hamadan
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice chancellor for researchو Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Mitra Zandieh
Position
Faculty member of Operating room Department for Paramedical school of Hamadan medical sciences un
Other areas of specialty/work
Street address
Department of Operating room, School of Paramedicine, Hamadan university of medical sciences, Shahid Fahmideh Ave. Hamadan
City
Hamadan
Postal code
Phone
+98 81 1838 1037
Fax
+98 81 1838 1017
Email
zandyeh@umsha.ac.ir; zandiyeh.mitra@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Mitra Zandieh
Position
Faculty member of Operatin room Department for Paramedical school of Hamadan medical sciences unive
Other areas of specialty/work
Street address
Department of Operating room, School of Paramedicine, Hamadan university of medical sciences, Shahid Fahmideh Ave. Hamadan
City
Hamadan
Postal code
Phone
+98 81 1838 1037
Fax
+98 81 1838 1017
Email
zandyeh@umsha.ac.ir; zandiyeh.mitra@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Mitra Zandieh
Position
Faculty member of Operating room Department for Paramedical school of Hamadan medical sciences un
Other areas of specialty/work
Street address
Department of Operating room , School of Paramedicine, Hamadan university of medical sciences , Shahid Fahmideh Ave. Hamadan
City
Hamadan
Postal code
Phone
+98 81 1838 1037
Fax
+98 81 1838 1017
Email
zandyeh@umsha.ac.ir; zandiyeh.mitra@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)