Burn Wound Management of Betafoam® and Allevyn® Ag
Primary Purpose
Acute Burn
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Betafoam
Allevyn Silver Dressing
Sponsored by
About this trial
This is an interventional treatment trial for Acute Burn focused on measuring Dressing for burn wounds
Eligibility Criteria
Inclusion Criteria:
- Adults ≥ 19 years
- Subjects of second-degree burn who have acute partial thickness burn (superficial to deep partial thickness) via investigator's visible assessment
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.)
- Subjects who voluntarily sign the informed consent form
Exclusion Criteria:
- Pregnant & lactating females
- Known allergy to the dressing product including PVP-I
- Known hyperthyroidism or other acute thyroid diseases
- Subject with clinical infection who should be administered antibiotics continuously after enrolment
- Subject has any condition(s) that seriously compromises the patient's ability to complete this study.
- Subject has participated in interventional study utilizing an investigational drug within the previous 30 days
- 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.
- Subjects who are immune suppressed states, under chemo- or radiotherapy.
- The surgeon decides that surgery is necessary or requiring skin grafting.
- Burn injury sites at the ends of extremities and genitalia
- Burn injury caused of electronic burn
- Subjects who have inhaled damage, severe head injury or fracture on burn wound
- Scintillation scan for the diagnosis of thyroid takes at intervals of 1 to 2 weeks when using this dressing
- Vulnerable subjects.
Sites / Locations
- Hallym University Hangang Sacred Heart Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Betafoam
Allevyn Silver dressing
Arm Description
Brand name: Betafoam® This is a medicated device (dressing) consisting of 3% povidone iodine.
Brand name: Allevyn® Silver
Outcomes
Primary Outcome Measures
Comparison between Betafoam® and Allevyn® Silver dressing, measured by days needed for complete re-epithelialization in burn wounds
Secondary Outcome Measures
Safety assessed by documentation of adverse events, clinical laboratory results and vital signs
Full Information
NCT ID
NCT02660541
First Posted
January 13, 2016
Last Updated
January 25, 2018
Sponsor
Mundipharma Korea Ltd
1. Study Identification
Unique Protocol Identification Number
NCT02660541
Brief Title
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
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
June 21, 2016 (Actual)
Primary Completion Date
February 28, 2017 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mundipharma Korea Ltd
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Burn
Keywords
Dressing for burn wounds
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Betafoam
Arm Type
Active Comparator
Arm Description
Brand name: Betafoam® This is a medicated device (dressing) consisting of 3% povidone iodine.
Arm Title
Allevyn Silver dressing
Arm Type
Active Comparator
Arm Description
Brand name: Allevyn® Silver
Intervention Type
Device
Intervention Name(s)
Betafoam
Intervention Description
Comparison between 2 medical devices
Intervention Type
Device
Intervention Name(s)
Allevyn Silver Dressing
Intervention Description
Comparison between 2 medical devices
Primary Outcome Measure Information:
Title
Comparison between Betafoam® and Allevyn® Silver dressing, measured by days needed for complete re-epithelialization in burn wounds
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Safety assessed by documentation of adverse events, clinical laboratory results and vital signs
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults ≥ 19 years
Subjects of second-degree burn who have acute partial thickness burn (superficial to deep partial thickness) via investigator's visible assessment
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.)
Subjects who voluntarily sign the informed consent form
Exclusion Criteria:
Pregnant & lactating females
Known allergy to the dressing product including PVP-I
Known hyperthyroidism or other acute thyroid diseases
Subject with clinical infection who should be administered antibiotics continuously after enrolment
Subject has any condition(s) that seriously compromises the patient's ability to complete this study.
Subject has participated in interventional study utilizing an investigational drug within the previous 30 days
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.
Subjects who are immune suppressed states, under chemo- or radiotherapy.
The surgeon decides that surgery is necessary or requiring skin grafting.
Burn injury sites at the ends of extremities and genitalia
Burn injury caused of electronic burn
Subjects who have inhaled damage, severe head injury or fracture on burn wound
Scintillation scan for the diagnosis of thyroid takes at intervals of 1 to 2 weeks when using this dressing
Vulnerable subjects.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dohern Kim, Dr.
Organizational Affiliation
Hangang Sacred Heart Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hallym University Hangang Sacred Heart Hospital
City
Seoul
ZIP/Postal Code
150719
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Burn Wound Management of Betafoam® and Allevyn® Ag
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