Clinical trial NCT02660541: Burn Wound Management of Betafoam® and Allevyn® Ag
Official title: A Pilot Study to Compare Efficacy of Allevyn® Silver Dressing and Betafoam® in Patients With Wound of Acute Burn Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Burn
Keywords: Dressing for burn wounds
Lead sponsor: Mundipharma Korea Ltd
Sponsor class: INDUSTRY
First posted: 2016-01-21
Enrollment: 32
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Comparison between Betafoam® and Allevyn® Silver dressing, measured by days needed for complete re-epithelialization in burn wounds
timeFrame: 28 days
Secondary outcomes:
measure: Safety assessed by documentation of adverse events, clinical laboratory results and vital signs
timeFrame: 28 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hallym University Hangang Sacred Heart Hospital
Study officials:
affiliation: Hangang Sacred Heart Hospital
name: Dohern Kim, Dr.
role: PRINCIPAL_INVESTIGATOR
References: