The Novel Electrolyzed Water Spray Treatment Discomfort, Redness and Swelling of the Skin Surrounding the Wound

Study Overview
=================
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.

Official Title
-----------------
A Novel Electrolyzed Water Spray Reduces Discomfort, Redness and Swelling of the Skin Surrounding the Wound Created by Skin Lasar Surgery: A Clinical Study

Conditions
-----------------
Skin Injury

Intervention / Treatment
-----------------
* Device: The novel electrolyzed water spray
* Device: The saline spray


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: An open label, two arm clinical study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The electrolyzed water spray group<br>Study staff will use the novel electrolyzed water spray device and spray for approximately 2-4 minutes on the participant's diseased area until half a bottle (20-40ml) of water is used. | Device: The novel electrolyzed water spray<br>* 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.<br>|
| Placebo Comparator: Control group of water spray<br>Study staff will use the saline and spray for approximately 2-4 minutes on the participant's diseased area until half a bottle (20-40ml) of water is used. | Device: The saline spray<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sense of discomfort scale made by the Numeric Pain Rating Scale (NPRS). | 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 . | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A skin signs scale made by modifying the Numeric Pain Rating Scale (NPRS). | 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. | 3 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Electrolyzed water device, Hydroxyl radical, Tap water, Spray, Laser surgery wound, Discomfort of the skin, Redness of the skin