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
32 participants
INTERVENTIONAL
2016-06-21
2017-05-31
Brief Summary
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A total of 40 patients will be enrolled in this study. Patients will be randomly assigned to Betafoam® or Allevyn® Silver dressing for burn wounds after acute burn injury.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Betafoam
Brand name: Betafoam® This is a medicated device (dressing) consisting of 3% povidone iodine.
Betafoam
Comparison between 2 medical devices
Allevyn Silver dressing
Brand name: Allevyn® Silver
Allevyn Silver Dressing
Comparison between 2 medical devices
Interventions
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Betafoam
Comparison between 2 medical devices
Allevyn Silver Dressing
Comparison between 2 medical devices
Eligibility Criteria
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Inclusion Criteria
2. Subjects of second-degree burn who have acute partial thickness burn (superficial to deep partial thickness) via investigator's visible assessment
3. Burn total body surface area of \<15% range based on Lund and Browder chart presenting at the emergency room within the first 3\~5 days post-injury will be considered for inclusion in this study.
4. Subjects who voluntarily sign the informed consent form
Exclusion Criteria
2. Known allergy to the dressing product including PVP-I
3. Known hyperthyroidism or other acute thyroid diseases
4. Subject with clinical infection who should be administered antibiotics continuously after enrolment
5. Subject has any condition(s) that seriously compromises the patient's ability to complete this study.
6. Subject has participated in interventional study utilizing an investigational drug within the previous 30 days
7. Subject has one or more medical condition(s), diabetes, including renal, hepatic, hematologic, neurologic, or immune disease that presumably to hinder the wound healing processes by the physician's judgement.
8. Subjects who are immune suppressed states, under chemo- or radiotherapy.
9. The surgeon decides that surgery is necessary or requiring skin grafting.
10. Burn injury sites at the ends of extremities and genitalia
11. Burn injury caused of electronic burn
12. Subjects who have inhaled damage, severe head injury or fracture on burn wound
13. Scintillation scan for the diagnosis of thyroid takes at intervals of 1 to 2 weeks when using this dressing
14. Vulnerable subjects.
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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Dohern Kim, Dr.
Role: PRINCIPAL_INVESTIGATOR
Hangang Sacred Heart Hospital
Locations
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Hallym University Hangang Sacred Heart Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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BTF15-KR-401
Identifier Type: -
Identifier Source: org_study_id
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