Environmental Exposure, Exposure to Pollution
Conditions
Keywords
Diethylhexyl Phthalate, Hand hygiene, Soaps, N-of-1 design, Cross-Over Studies
Brief summary
The aim of the study is to evaluate the effectiveness in removing chemical exposure on hand, the investigators compare removal efficiency of Di-(2-ethylhexyl)phthalate (DEHP) on hands by hand washing with soap and water vs. water only. In two three-day N-of-1 trials, residual DEHP was measured in a single female adult who washed exposed hands with soap-and-water or water-only. Subsequently, a crossover study was performed by randomly assigning another 28 subjects equally to wash with soap-and-water or with water-only, and then each one received the other treatment 24 hrs later.
Detailed description
Three studies, consisting of two N-of-1 trials and one crossover study, were used to compare the effect of handwashing with soap and water (intervention) and handwashing with water only (placebo) on phthalate removal from hands. The soap was plain soap, consisting of vegetable oil and sodium hydroxide. First, the investigators recruited one healthy female aged 25 yrs to participate in two N-of-1 trials. In each trial, her hands would be exposed to DEHP and then be treated with either soap intervention or placebo for three times over the course of three days. The first trial started on 15 May 2013. On day one, after the subject prewashed her hands, she allowed her hands to be exposed to a designated amount of DEHP. She then washed them with water only and rinsed them sequentially in three separate polyethylene (PE) bags, each containing 200 mL water to collect DEHP residue. One hour later, the same protocol was followed, except the exposed hands were treated with soap and water instead of water only (Figure 1a). The water rinsing in three separate bags remained the same. The pairs of studies were repeated on two subsequent days (16 and 17 May). In the second N-of-1 trial, which was also performed over three days (22-24 May), the protocol using the same subject remained the same for all three days, except that the subject underwent intervention first then placebo. The water rinsing remained the same. A randomized 2 × 2 crossover study was subsequently conducted between June and September 2013. The investigators assigned one group of 7 females and 7 males to perform handwashing with soap and water (intervention) and another group of 7 females and 7 males to perform handwashing with water only (placebo). Briefly, on the first day, the two groups washed their DEHP exposed hands using either soap and water or water only and then rinsed them in a PE bag with 200 mL water to collect DEHP. After 24 hrs, the experiment was crossed-over with the same two groups receiving the opposite treatments.
Interventions
handwashing with soap by a standardized 6-step handwashing technique
handwashing with water by a standardized 6-step handwashing technique
Sponsors
Study design
Eligibility
Inclusion criteria
* healthy adult over age of 18 years * BMI\>18
Exclusion criteria
* diagnosis of any type of cancers, dermatitis, asthma * cut, abrasion, and trauma on hands * BMI \<18
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of Diethylhexyl Phthalate Removed From Hand | immediately right after hand-washing | Water rinse were performed immediately after hand-washing, and the concentration of diethylhexyl phthalate in the soiled water is measured. |
Countries
Taiwan
Participant flow
Recruitment details
Participants were recruited from Kaohsiung Medical university in Kaohsiung City, Taiwan from May, 2013 to September, 2013.
Participants by arm
| Arm | Count |
|---|---|
| All 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. | 28 |
| Total | 28 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants |
| Age, Continuous | 21.9 years STANDARD_DEVIATION 1.6 |
| Region of Enrollment Taiwan | 28 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 28 |
| other Total, other adverse events | 0 / 28 | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 | 0 / 28 |
Outcome results
Amount of Diethylhexyl Phthalate Removed From Hand
Water rinse were performed immediately after hand-washing, and the concentration of diethylhexyl phthalate in the soiled water is measured.
Time frame: immediately right after hand-washing
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Amount of Diethylhexyl Phthalate Removed From Hand | Intervention | 94.64 percentage of DEHP removed | Standard Deviation 6.49 |
| All Participants | Amount of Diethylhexyl Phthalate Removed From Hand | Placebo | 8.74 percentage of DEHP removed | Standard Deviation 5.69 |