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

Primary Purpose

Skin Injury

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
The novel electrolyzed water spray
The saline spray
Sponsored by
Dove Medical Press Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Injury focused on measuring Electrolyzed water device, Hydroxyl radical, Tap water, Spray, Laser surgery wound, Discomfort of the skin, Redness of the skin

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Huinuode Biotechnology Co., Ltd.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

The electrolyzed water spray group

Control group of water spray

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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 ".

Secondary Outcome Measures

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".

Full Information

First Posted
February 27, 2023
Last Updated
August 13, 2023
Sponsor
Dove Medical Press Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05792306
Brief Title
The Novel Electrolyzed Water Spray Treatment Discomfort, Redness and Swelling of the Skin Surrounding the Wound
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 29, 2023 (Actual)
Primary Completion Date
July 15, 2023 (Actual)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dove Medical Press Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Injury
Keywords
Electrolyzed water device, Hydroxyl radical, Tap water, Spray, Laser surgery wound, Discomfort of the skin, Redness of the skin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
An open label, two arm clinical study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The electrolyzed water spray group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group of water spray
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
The novel electrolyzed water spray
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
The saline spray
Intervention Description
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.
Primary Outcome Measure Information:
Title
The sense of discomfort scale made by the Numeric Pain Rating Scale (NPRS).
Description
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 ".
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
A skin signs scale made by modifying the Numeric Pain Rating Scale (NPRS).
Description
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".
Time Frame
3 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Huinuode Biotechnology Co., Ltd.
City
Qingdao
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
until publication of this clinical study and international patent granted

Learn more about this trial

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

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