Compare of Petrolatum Gauze, Allevyn, and New Dressing, Betafoam® in the Management of Split-Thickness Skin Graft Donor Site

Study Overview
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Brief Summary
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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.

Official Title
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Randomized, Controlled, Phase IV Study of Petrolatum Gauze, Allevyn, and New Dressing, Betafoam® in the Management of Split-Thickness Skin Graft Donor Site

Conditions
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Skin Graft

Intervention / Treatment
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* Device: Betafoam Wound Dressing
* Device: Petrolatum Gauze
* Device: Allevyn Wound Dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who is same as or more than 19 years old Patients who will receive elective skin harvest operation Patients who is in lateral thigh or buttock with donor site area from 50 to 150 cm2 Female patients who use method of contraception for the study Patients who voluntarily sign the informed consent Exclusion Criteria: Patients who are pregnant Patients who are known to have allergy to the dressing product including PVPI Known hyperthyroidism or other thyroid dysfunction such as nodular thyroid goiter, endemic goiter and Hashimoto's thyroiditis or patients who receive radioiodine therapy 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 Patients who receive anticoagulants, steroids or immunosuppressants Patients who have signs and symptoms of infection on enrollment and adversely affect wound healing Patients who have skin lesion such as Herpes zoster on donor site Burn of >20% total body surface area If the donor site had been harvested on a previous occasion Patients who is limited cognitive ability Patients who are participating in or will plan to participate in other clinical trials Other various conditions that the investigators judge inappropriate for enrolment

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Betafoam Wound Dressing<br>This contains 3% povidone iodine. Dressing will be routinely changed on day 3 and day 7, and can be replaced anytime due to various factors such as exudate control, dislodgement, or by investigators' clinical decision. | Device: Betafoam Wound Dressing<br>* Foam dressing including Betadine iodine<br>* Other names: Betafoam;|
| Active Comparator: Petrolatum Gauze<br>Dressing will be routinely changed on day 3 and day 7 and can be replaced anytime due to various factors such as exudate control, dislodgement, or by investigators' clinical decision. | Device: Petrolatum Gauze<br>* Gauze dressing<br>|
| Active Comparator: Allevyn Wound Dressing<br>Allevyn adhesive wound dressing will be routinely changed on day 3 and day 7 and can be replaced anytime due to various factors such as exudate control, dislodgement, or by investigators' clinical decision. | Device: Allevyn Wound Dressing<br>* Foam dressing<br>* Other names: Allevyn;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy as measured by speed of wound healing | Days needed for complete skin epithelialization in donor site wounds through routine swab culture (1 and 3 days) and visual assessment of wounds | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy as measured by adverse event collection |  | 6 months |