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

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

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.

Study Overview

• Status: Completed
• Conditions: Skin Injury
• Intervention / Treatment: Device: The novel electrolyzed water spray; Device: The saline spray

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Qingdao, China
    • Huinuode Biotechnology Co., Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The electrolyzed water spray group; 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; 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.
Placebo Comparator: Control group of water spray; 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; 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.

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

Collaborators and Investigators

• Sponsor: Dove Medical Press Ltd
• Collaborators: The Affiliated Hospital of Qingdao University

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2023
• Primary Completion (Actual): July 15, 2023
• Study Completion (Actual): March 10, 2024

Study Registration Dates

• First Submitted: February 27, 2023
• First Submitted That Met QC Criteria: March 18, 2023
• First Posted (Actual): March 31, 2023

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Spray; Electrolyzed water device; Hydroxyl radical; Tap water; Laser surgery wound; Discomfort of the skin; Redness of the skin
• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Erythema
• Other Study ID Numbers: jia19920107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: until publication of this clinical study and international patent granted
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No