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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041240137
Enrollment
20
Registered
2024-12-02
Start date
2024-12-02
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Requiring Split-Thickness Skin Grafting

Interventions

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 sk

Sponsors

Ebisawa Katsumi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
The difference in epithelialization rates between the PAL-treated and saline-treated areas on postoperative day 7.

Secondary

MeasureTime frame
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)

Contacts

Public ContactKatsumi Ebisawa

Nagoya University Hospital

ebisawa@med.nagoya-u.ac.jp+81-52-744-2525

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026