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

Skin Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05792306
• Other study ID #: jia19920107
• Status: Completed
• Phase: N/A
• Start date: January 29, 2023
• Est. completion date: March 10, 2024

Study information

• Verified date: February 2023
• Source: Dove Medical Press Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 10, 2024
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Erythema
• Skin Injury

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Huinuode Biotechnology Co., Ltd.	Qingdao

Sponsors (1)

Lead Sponsor	Collaborator
Dove Medical Press Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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