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

Not Applicable

Completed

• Conditions: Skin Injury
• Interventions: Device: The novel electrolyzed water spray; Device: The saline spray

• Registration Number: NCT05792306
• Lead Sponsor: Dove Medical Press Ltd

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.

Study Timeline

• Study Start: 2023-01-29
• Status Verified: 2023-02
• Study First Submitted: 2023-02-27
• Study First Submitted QC: 2023-03-18
• Study First Posted: 2023-03-31
• Primary Completion: 2023-07-15
• Study Completion: 2024-03-10
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The electrolyzed water spray group	The novel electrolyzed water spray	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.
Control group of water spray	The saline 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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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".

Trial Locations

Locations (1)

Huinuode Biotechnology Co., Ltd.; 🇨🇳 Qingdao, China