Trial Outcomes & Findings for Residual Effect of Chlorhexidine-alcohol Compared to Triclosan-alcohol (NCT NCT01762904)
NCT ID: NCT01762904
Last Updated: 2014-07-02
Results Overview
135 determinations to evaluate residual effect of 2% chlorhexidine in 70% isopropyl alcohol. All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 2% chlorhexidine in 70% isopropyl alcohol was tested. Were prepared the skin area of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h, everyone on different days. Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h.
COMPLETED
PHASE3
135 participants
24 hours
2014-07-02
Participant Flow
Participant milestones
| Measure |
Whole Group of 135 Units of Measurement
The arm is composed of 135 units of measurement, it means, 540 determinations to test 2% chlorhexidine gluconate in 70% isopropyl alcohol and 1% triclosan in 70% isopropyl alcohol and two controls.
The principal unit of measurement it will be four determinations of bacterial counts in a subject for antiseptics and controls to test each of the application sites, and determination as to each separately sampling for each area for each antiseptic forearm. The same subject may be assessed up to three separate occasions provided only after a minimum period of two weeks between each determination.
Interventions:
* Biological: Bacterial culture of the prepared skin's areas with two antiseptics and two controls
* Other: Preparing skin's areas to be tested with two antiseptics and two controls
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|---|---|
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Overall Study
STARTED
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135
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Overall Study
COMPLETED
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135
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Residual Effect of Chlorhexidine-alcohol Compared to Triclosan-alcohol
Baseline characteristics by cohort
| Measure |
Whole Group of 135 Units of Measurement
n=119 Participants
The arm is composed of 135 units of measurement, it means, 540 determinations to test 2% chlorhexidine gluconate in 70% isopropyl alcohol and 1% triclosan in 70% isopropyl alcohol and two controls.
The principal unit of measurement it will be four determinations of bacterial counts in a subject for antiseptics and controls to test each of the application sites, and determination as to each separately sampling for each area for each antiseptic forearm. The same subject may be assessed up to three separate occasions provided only after a minimum period of two weeks between each determination.
Interventions:
* Biological: Bacterial culture of the prepared skin's areas with two antiseptics and two controls
* Other: Preparing skin's areas to be tested with two antiseptics and two controls
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Age, Continuous
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22 years
n=99 Participants
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Sex: Female, Male
Female
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59 Participants
n=99 Participants
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Sex: Female, Male
Male
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60 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: 24 hours135 determinations to evaluate residual effect of 2% chlorhexidine in 70% isopropyl alcohol. All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 2% chlorhexidine in 70% isopropyl alcohol was tested. Were prepared the skin area of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h, everyone on different days. Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h.
Outcome measures
| Measure |
Whole Group of 135 Units of Measurement
n=119 Participants
135 determinations to test 2% chlorhexidine in 70% isopropyl alcohol.
All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 2% chlorhexidine in 70% isopropyl alcohol was tested. Were prepared the skin area of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h, everyone on different days.
Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h.
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|---|---|
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Evaluate the Residual Effect of Chlorhexidine 2% / Isopropyl Alcohol 70% Administered Topically
3 h
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48 (CFU/cm2)
Interval 12.0 to 96.0
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Evaluate the Residual Effect of Chlorhexidine 2% / Isopropyl Alcohol 70% Administered Topically
24 h
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24 (CFU/cm2)
Interval 0.0 to 84.0
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Evaluate the Residual Effect of Chlorhexidine 2% / Isopropyl Alcohol 70% Administered Topically
0 h
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24 (CFU/cm2)
Interval 0.0 to 120.0
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PRIMARY outcome
Timeframe: 24 hours135 determinations to test 1% triclosan in 70% isopropyl alcohol. All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 1% triclosan in 70% isopropyl alcohol was tested. Were prepared the skin area of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h, everyone on different days. Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h.
Outcome measures
| Measure |
Whole Group of 135 Units of Measurement
n=119 Participants
135 determinations to test 2% chlorhexidine in 70% isopropyl alcohol.
All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 2% chlorhexidine in 70% isopropyl alcohol was tested. Were prepared the skin area of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h, everyone on different days.
Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h.
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Evaluate the Residual Effect of Triclosan 1% / Isopropyl Alcohol 70% Administered Topically.
0 h
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48 (CFU/cm2)
Interval 0.0 to 180.0
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Evaluate the Residual Effect of Triclosan 1% / Isopropyl Alcohol 70% Administered Topically.
3 h
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48 (CFU/cm2)
Interval 0.0 to 120.0
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Evaluate the Residual Effect of Triclosan 1% / Isopropyl Alcohol 70% Administered Topically.
24 h
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96 (CFU/cm2)
Interval 24.0 to 192.0
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PRIMARY outcome
Timeframe: 24 hrs135 units of measurement to test two controls. Principal unit of measurement: four determinations of bacterial counts in a subject for antiseptics and controls to test each of the application sites. All volunteers was provided with a neutral soap without antiseptics for use of two weeks. Deionized water redistilled (Control 2: Control with scrub) and Scrub the skin without prior application of any substance (Control1: Control without scrub) was tested. Were prepared two skin's areas of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h. Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h.
Outcome measures
| Measure |
Whole Group of 135 Units of Measurement
n=119 Participants
135 determinations to test 2% chlorhexidine in 70% isopropyl alcohol.
All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 2% chlorhexidine in 70% isopropyl alcohol was tested. Were prepared the skin area of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h, everyone on different days.
Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h.
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|---|---|
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Evaluate the Effect on the Skin Flora Application Process of Antiseptics by Sterile Swab
Control 1: without scrub 0 h
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480 (CFU/cm2)
Interval 288.0 to 1020.0
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Evaluate the Effect on the Skin Flora Application Process of Antiseptics by Sterile Swab
Control 2: scrub with Deionized water redisti 0 h
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216 (CFU/cm2)
Interval 96.0 to 348.0
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Evaluate the Effect on the Skin Flora Application Process of Antiseptics by Sterile Swab
Control 1: without scrub 3 h
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288 (CFU/cm2)
Interval 144.0 to 924.0
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Evaluate the Effect on the Skin Flora Application Process of Antiseptics by Sterile Swab
Control 2: scrub with Deionized water redisti 3 h
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96 (CFU/cm2)
Interval 48.0 to 372.0
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Evaluate the Effect on the Skin Flora Application Process of Antiseptics by Sterile Swab
Control 1: without scrub 24 h
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288 (CFU/cm2)
Interval 192.0 to 576.0
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Evaluate the Effect on the Skin Flora Application Process of Antiseptics by Sterile Swab
Control 2: scrub with Deionized water redisti 24 h
|
96 (CFU/cm2)
Interval 48.0 to 384.0
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SECONDARY outcome
Timeframe: 24 hours135 units of measurement to test two antiseptics and two controls. Principal unit of measurement: four determinations of bacterial counts in a subject for antiseptics and controls to test each of the application sites. All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 2% chlorhexidine in 70% isopropyl alcohol and 1% triclosan in 70% isopropyl alcohol, Deionized water redistilled and Scrub the skin without prior application of any substance was tested. We prepared four skin's areas of 25 cm2, two in each forearm. The solution remained on the skin for 60s, 3h and 24h. Presence of allergy or any skin reaction at 24 hours after the antiseptic application.
Outcome measures
| Measure |
Whole Group of 135 Units of Measurement
n=119 Participants
135 determinations to test 2% chlorhexidine in 70% isopropyl alcohol.
All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 2% chlorhexidine in 70% isopropyl alcohol was tested. Were prepared the skin area of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h, everyone on different days.
Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h.
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|---|---|
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Detect Presence of Allergy or Skin Reaction by the Antiseptic Application
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0 participants
Interval 0.0 to 3.0
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Adverse Events
Whole Group of 135 Units of Measurement
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place