Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2025-12-25 @ 2:35 AM
NCT ID:
NCT02543034
Eligibility Criteria:
Inclusion Criteria:
1. Patients who is same as or more than 19 years old
2. Patients who will receive elective skin harvest operation
3. Patients who is in lateral thigh or buttock with donor site area from 50 to 150 cm2
4. Female patients who use method of contraception for the study
5. Patients who voluntarily sign the informed consent
Exclusion Criteria:
1. Patients who are pregnant
2. Patients who are known to have allergy to the dressing product including PVPI
3. Known hyperthyroidism or other thyroid dysfunction such as nodular thyroid goiter, endemic goiter and Hashimoto's thyroiditis or patients who receive radioiodine therapy
4. Co-morbidities which may adversely affect wound healing for example a patient with uncontrolled diabetes (HbA1c \> 8%), chronic renal failure, autoimmune disease, or immunocompromised patient
5. Patients who receive anticoagulants, steroids or immunosuppressants
6. Patients who have signs and symptoms of infection on enrollment and adversely affect wound healing
7. Patients who have skin lesion such as Herpes zoster on donor site
8. Burn of \>20% total body surface area
9. If the donor site had been harvested on a previous occasion
10. Patients who is limited cognitive ability
11. Patients who are participating in or will plan to participate in other clinical trials
12. Other various conditions that the investigators judge inappropriate for enrolment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT02543034
Study Brief:
Protocol Section:
NCT02543034