Ajou University Hospital
Gyeonggi-do, South Korea
NCT Number: NCT05994781
This clinical study is conducted prospectively for 3 months after medical device treatment.
It is a comparative clinical study of the leading control group.
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Notify Me19 year and older
All sexes
Interventional
Not applicable
Gyeonggi-do, South Korea
Subjects need tissue transplantation to repair skin defects, so partial layer skin transplantation is performed. After proceeding, the patient is no longer subject to exudation. Subjects (and/or legal representatives) have agreed in writing to participate in the clinical study Perform a post-screening test.
Evaluating the screening test results, meeting the selection criteria, and meeting the exclusion criteria those who do not are registered for clinical research.
In the case of the study group among the subjects of the clinical study, whether partial layer skin transplantation was performed or not, Apply an appropriate amount of EasyDew MD Regen Cream twice a day (morning and evening) and can be absorbed well.
The control group is a non-treatment group, and for 3 months after the procedure. General moisturizers that have been used or will be used are available. The control group's Moisturizer is recommended twice a day (morning and evening) on whether skin grafts are collected or not Apply and allow good absorption. After applying medical devices and moisturizers for clinical research, the progress will be observed for 3 months, Subjects are a screening visit (Visit1), the day of medical device application (Visit2), and after medical device application.
Visit the research institution regularly for one month (Visit3) and three months after application (Visit4) for validity and it will be evaluated for safety.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
No intervention
Other names: No treatment
Time frame: Before, after one month after application, 3 month after application
Transepidermal water loss score/ No range of upper and lower score, the lower is best
Time frame: Before, after one month after application, 3 month after application
Assess the patient's overall condition /lowest 0 score ( best score) to highest 30 score( worst score)
Time frame: Before, after one month after application, 3 month after application
Assess patient quality of life / lowest 0 score ( best score) to highest 4 score( worst score)
Time frame: Before, after one month after application, 3 month after application
Evaluate the Itching scale / lowest 1 score ( best score) to highest 5 score( worst score)
Time frame: Before, after one month after application, 3 month after application
Vancouver Scar Scale/ No range of upper and lower score, the lower is best
Eun-ji Kim
Industry
A Prospective Researcher-led Clinical Study to Evaluate the Effectiveness and Safety of the Application of Neopep-S-based Easy Dew MD Regen Cream in Partial Layer Skin Transplantation
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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