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IRCT2013041513017N1 IRCT 2013-05-22 vice chancellor for researchو Hamadan University of Medical Sciences Antibacterial effectiveness of Betadine- alcohol, Decosept, septicidin and Sterillium on hand bacterial flora Comparison study of antibacterial effectiveness of Betadine-alcohol, Decosept, septicidin and Sterillium for surgical hand anticepcis on hand bacterial flora 2012-06-02 anticipated 20 Complete https://irct.ir/trial/12967 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Prevention. N/A topical agent. Intervention 1: 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). Intervention 2: 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). Intervention 3: 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). Intervention 4: 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). Intervention 5: 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).
public Mitra Zandieh
Department of Operating room, School of Paramedicine, Hamadan university of medical sciences, Shahid Fahmideh Ave. Hamadan
Hamadan Iran (Islamic Republic of) +98 81 1838 1037 zandyeh@umsha.ac.ir; zandiyeh.mitra@yahoo.com Hamadan University of Medical Sciences scientific Mitra Zandieh
Department of Operating room, School of Paramedicine, Hamadan university of medical sciences, Shahid Fahmideh Ave. Hamadan
Hamadan Iran (Islamic Republic of) +98 81 1838 1037 zandyeh@umsha.ac.ir; zandiyeh.mitra@yahoo.com Hamadan University of Medical Sciences Iran (Islamic Republic of) 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. 18 years no limit Both Y56.9 Topical agent, unspecified Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs 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). 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). 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). 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). 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). 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. 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. 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 ). vice chancellor for researchو Hamadan University of Medical Sciences Approved 2012-05-14 local human subject review boardo, vice chancellor of research technology, Hamadan university of med Hamadan university of medical sciences, Shahid Fahmideh Ave Hamadan Iran (Islamic Republic of)