Trial Outcomes & Findings for Removal of Dermal Exposure to Phthalate Ester by Hand Washing (NCT NCT02707172)
NCT ID: NCT02707172
Last Updated: 2018-10-23
Results Overview
Water rinse were performed immediately after hand-washing, and the concentration of diethylhexyl phthalate in the soiled water is measured.
COMPLETED
NA
28 participants
immediately right after hand-washing
2018-10-23
Participant Flow
Participants were recruited from Kaohsiung Medical university in Kaohsiung City, Taiwan from May, 2013 to September, 2013.
Participant milestones
| Measure |
All Participants
All participants underwent two experiments, one with placebo (handwashing with water) and one with intervention (handwashing with soap), but in different order.
28 participants underwent placebo first and crossed-over to received intervention; while the other 28 participants underwent intervention first and then placebo. There was one day wash-out period between the two sets of experiment.
In each set of the experiment, each participant was exposed to 1000 microgram of diethylhexyl phthalate on both hands, and was asked to perform the placebo or intervention by a standardized hand washing technique depending on the sequence assignment.
A total of 56 placebo experiments were performed and a total of 56 intervention experiments were performed in the study.
|
|---|---|
|
1st Set of Experiment
STARTED
|
28
|
|
1st Set of Experiment
COMPLETED
|
28
|
|
1st Set of Experiment
NOT COMPLETED
|
0
|
|
Wash Out
STARTED
|
28
|
|
Wash Out
COMPLETED
|
28
|
|
Wash Out
NOT COMPLETED
|
0
|
|
2nd Set of Experiment
STARTED
|
28
|
|
2nd Set of Experiment
COMPLETED
|
28
|
|
2nd Set of Experiment
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Removal of Dermal Exposure to Phthalate Ester by Hand Washing
Baseline characteristics by cohort
| Measure |
All Participants
n=28 Participants
A total of 28 participants were recruited and were divided into two groups, one group receiving placebo first and then intervention, the other group receiving intervention first and then placebo.
The placebo is handwashing with water using the 6-step standardized handwashing technique.
The intervention is handwasahing with soap using the 6-step standardized handwashing technique.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
21.9 years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: immediately right after hand-washingPopulation: Each participant underwent two sets of experiments, one with placebo and one with intervention. 14 participants received placebo first and were crossed-over to received intervention. The other 14 participants received intervention first and were crossed-over to received placebo.
Water rinse were performed immediately after hand-washing, and the concentration of diethylhexyl phthalate in the soiled water is measured.
Outcome measures
| Measure |
All Participants
n=28 Participants
A total of 28 participants were recruited and were divided into two groups, one group receiving placebo first and then intervention, the other group receiving intervention first and then placebo.
The placebo is handwashing with water using the 6-step standardized handwashing technique.
The intervention is handwasahing with soap using the 6-step standardized handwashing technique.
|
|---|---|
|
Amount of Diethylhexyl Phthalate Removed From Hand
Intervention
|
94.64 percentage of DEHP removed
Standard Deviation 6.49
|
|
Amount of Diethylhexyl Phthalate Removed From Hand
Placebo
|
8.74 percentage of DEHP removed
Standard Deviation 5.69
|
Adverse Events
Intervention
Placebo
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