A Clinical Study for plasma-activated Lactate Ringer's SolutionL(PAL) Topical Application on the Donor Site of Split-thickness Skin Grafts

JRCT ID: jRCTs041240137

Registered date:02/12/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Patients Requiring Split-Thickness Skin Grafting
• Date of first enrollment: 02/12/2024
• Target sample size: 20
• Study type: Interventional

Intervention(s)

This is a blinded study evaluating the effects of PAL administration on epithelialization, using normal saline administration as the control. Participants are patients scheduled for split-thickness skin grafting with split-thickness donor site wounds. A hydrocolloid dressing will be applied to the donor site wound's peripheral and central areas. Gauze soaked with PAL will be applied to one side, and soaked with normal saline will be applied to the other. After 5 minutes, the gauze will be removed, and the area will be covered with a waterproof film dressing. Wound observation and photography will be conducted on postoperative days 7, 10, 14, 17, and 21, as well as at 1, 3, and 6 months. Additional wound observation and photography will be performed on days other than those mentioned to confirm complete epithelialization if full epithelialization is expected. In the event of abnormal findings, monitoring will continue until normalization is observed.
Additionally, on postoperative days 1-2, exudate from within the film dressing will be collected for protein analysis.

Outcome(s)

• Primary Outcome: The difference in epithelialization rates between the PAL-treated and saline-treated areas on postoperative day 7.

Secondary Outcome

1. The difference in epithelialization rates between the PAL-treated area and the saline-treated area on postoperative days 10, 14, 17, and 21
2. The number of days required for complete epithelialization in the PAL-treated area and the saline-treated area
3. Protein analysis of wound exudate (PAL-treated area vs. saline-treated area)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Ages 18 and over
2. Patients undergoing split-thickness skin grafting
3. Subjects who received a sufficient explanation of the purpose and contents of this study voluntarily apply for participation after fully understanding, agreeing in writing

Exclude criteria

1. Subjects who cannot keep the affected area rest
2. Subjects with cognitive problems
3. Subjects with decision-making problems
4. Subjects in the department to which the principal investigator and co-investigator belong
5. In addition, subjects judged unsuitable for doctors to carry out this study safely

Related Information

• Primary Sponsor: Ebisawa Katsumi
• Source(s) of Monetary Support: FUJI CORPORATION