Compare of Petrolatum Gauze, Allevyn, and New Dressing, Betafoam® in the Management of Split-Thickness Skin Graft Donor Site
NCT ID: NCT02543034
Last Updated: 2017-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
105 participants
INTERVENTIONAL
2016-03-16
2017-05-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Betafoam Wound Dressing
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.
Betafoam Wound Dressing
Foam dressing including Betadine iodine
Petrolatum Gauze
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.
Petrolatum Gauze
Gauze dressing
Allevyn Wound Dressing
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.
Allevyn Wound Dressing
Foam dressing
Interventions
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Betafoam Wound Dressing
Foam dressing including Betadine iodine
Petrolatum Gauze
Gauze dressing
Allevyn Wound Dressing
Foam dressing
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
ALL
No
Sponsors
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Mundipharma Korea Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Jongwon Lee, Dr.
Role: PRINCIPAL_INVESTIGATOR
Seoul St. Mary's Hospital, The Catholic University of Korea
Locations
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Seoul St. Mary's Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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BTF14-KR-401
Identifier Type: -
Identifier Source: org_study_id