Acute Burn
Conditions
Keywords
Dressing for burn wounds
Brief summary
This is a randomized, controlled, multi-centre, open-label study. 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.
Interventions
DEVICEBetafoam
Comparison between 2 medical devices
DEVICEAllevyn Silver Dressing
Comparison between 2 medical devices
Sponsors
Mundipharma Korea Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults ≥ 19 years 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. (If more than one burn wound is present that meets the inclusion criteria, the largest one among wounds that size are between 10x10 ㎝ and 20x20㎝ will be preferred to select as the Target wound.) 4. Subjects who voluntarily sign the informed consent form
Exclusion criteria
1. Pregnant & lactating females 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison between Betafoam® and Allevyn® Silver dressing, measured by days needed for complete re-epithelialization in burn wounds | 28 days |
Secondary
| Measure | Time frame |
|---|---|
| Safety assessed by documentation of adverse events, clinical laboratory results and vital signs | 28 days |
Countries
South Korea
Outcome results
None listed