Skin Injury
Conditions
Keywords
Electrolyzed water device, Hydroxyl radical, Tap water, Spray, Laser surgery wound, Discomfort of the skin, Redness of the skin
Brief summary
The purpose of this study is to test whether the reduction of the sense of discomfort and redness and swelling of the skin surrounding the wound of patients by use of the novel electrolyzed water spray will relieve the inflammation of the skin.
Detailed description
In this study, water inculding tap water,pure water and salt water, and an apparatus for producing electrolyzed water (https://www.deposon.com.cn; https://www.deposon.com）were used to generate an electrolyzed water mist spray or spray. This instantly generated electrolyzed water mist spray or spray has oxidation-reduction potential (ORP) ≥1200mv,and contains non-specific total oxidation capacity which equals to 0.28±0.10ppm,0.06±0.04ppm and 3.92±0.39ppm of desolved ozone. This instantly generated electrolyzed water mist spray or spray does not release detectable ≥0.1mg/m3 of gaseous ozone. This instantly generated electrolyzed water mist spray or spray has pH 8.4±0.4 and releases negative air ion.The apparatus for producing electrolyzed water has a positive electrode which is covered by a conductive diamond material (Patent# CN215308550U). In this study, this novel electrolyzed water device and the water spray are used to treat wounds created by skin laser surgery.
Interventions
The researcher use electrolyzed water to treat the diseased area, two times a day, for 5 days. The trial consists of 5 study visits (day 1-day 5). The reduction in the disease area of discomfort, redness and swelling evaluation and adverse event assessments will be performed at each visit. Safety analysis will be assessed based on the reports of adverse events during the study.
DEVICEThe saline spray
The researcher use saline to treat the diseased area, two times a day, for 5 days. The trial consists of 5 study visits (day 1-day 5). The reduction in the disease area of discomfort, redness and swelling evaluation and adverse event assessments will be performed at each visit. Safety analysis will be assessed based on the reports of adverse events during the study.
Sponsors
Dove Medical Press Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
An open label, two arm clinical study
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Mild discomfort, redness and swelling of the skin surrounding the wound created by skin laser surgery * Patient \> 18 years old.
Exclusion criteria
* Severe discomfort, redness and swelling of the skin surrounding the wound created by skin laser surgery. * 80 years or older. * Pregnant or breastfeeding women * Systemically healthy individuals.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The sense of discomfort scale made by the Numeric Pain Rating Scale (NPRS). | 1 hour | This score is based on descriptions of the discomfort of the skin surrounding the wound that patients rate 0-10 to assess the condition of their skin. A higher score means a worse outcome. 0 means no discomfort and 10 means the most discomfort . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| A skin signs scale made by modifying the Numeric Pain Rating Scale (NPRS). | 3 hour | The skin signs scale evaluations the signs of skin wound inflammation including redness and swelling of the skin immediately surrounding the wound. This score is based on descriptions of the redness and swelling of the skin surrounding the wound that patients rate 0-10 to assess the condition of their skin. A higher score means a worse outcome. 0 means no redness and swelling of the skin surrounding the wound and 10 means the most redness and swelling surrounding the wound. |
Countries
China
Outcome results
None listed