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

NCT05792306 | Completed DMC

• 1 other identifier: jia19920107
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Injury

Keywords

Electrolyzed water device; Hydroxyl radical; Tap water; Spray; Laser surgery wound; Discomfort of the skin; Redness of the skin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• A skin signs scale made by modifying the Numeric Pain Rating Scale (NPRS).

  3 hour

Study Arms (2)

The electrolyzed water spray group

EXPERIMENTAL

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

Control group of water spray

PLACEBO COMPARATOR

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

Interventions

The novel electrolyzed water spray DEVICE

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 electrolyzed water spray group

The saline spray DEVICE

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.

Control group of water spray

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mild discomfort, redness and swelling of the skin surrounding the wound created by skin laser surgery
• Patient \> 18 years old.

You may not qualify if:

• Severe discomfort, redness and swelling of the skin surrounding the wound created by skin laser surgery.
• years or older.
• Pregnant or breastfeeding women
• Systemically healthy individuals.

Sponsors & Collaborators

• Dove Medical Press Ltd: lead

Study Sites (1)

Huinuode Biotechnology Co., Ltd.

Qingdao, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: An open label, two arm clinical study

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 31, 2023
• Study Start: January 29, 2023
• Primary Completion: July 15, 2023
• Study Completion: March 10, 2024
• Last Updated: April 25, 2024

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: until publication of this clinical study and international patent granted

Locations

CN (1)