Skin Graft
Conditions
Brief summary
This study is a randomized, controlled, multi-centre, open-label, phase IV study. Total 81 patients will be enrolled in this study. Patients will be randomly assigned to Betafoam®, petrolatum gauze or Allevyn for donor site wounds after skin graft operation.
Interventions
DEVICEBetafoam Wound Dressing
Foam dressing including Betadine iodine
DEVICEPetrolatum Gauze
Gauze dressing
DEVICEAllevyn Wound Dressing
Foam dressing
Sponsors
Mundipharma Korea Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy as measured by speed of wound healing | 6 months | Days needed for complete skin epithelialization in donor site wounds through routine swab culture (1 and 3 days) and visual assessment of wounds |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy as measured by adverse event collection | 6 months |
Countries
South Korea
Outcome results
None listed