Acute BurnNCT02660541
Burn Wound Management of Betafoam® and Allevyn® Ag
A study testing Betafoam and Allevyn Silver Dressing in people with Acute Burn, run by Mundipharma Korea Ltd at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Burn
- What is being tested?
- Betafoam and Allevyn Silver Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Jun 2016to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Hallym University Hangang Sacred Heart Hospital
Seoul, 150719
About this study
Official title: A Pilot Study to Compare Efficacy of Allevyn® Silver Dressing and Betafoam® in Patients With Wound of Acute Burn Injury
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.
- Conditions
- Acute Burn
- Being tested
- Betafoam, Allevyn Silver Dressing
- Keywords
- Dressing for burn wounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BetafoamDevice
Comparison between 2 medical devices
Allevyn Silver DressingDevice
Comparison between 2 medical devices
| Study group | Role | What they receive |
|---|---|---|
| Betafoam | Active comparator | Brand name: Betafoam® This is a medicated device (dressing) consisting of 3% povidone iodine. Receives: Device: Betafoam |
| Allevyn Silver dressing | Active comparator | Brand name: Allevyn® Silver Receives: Device: Allevyn Silver Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between Betafoam® and Allevyn® Silver dressing, measured by days needed for complete re-epithelialization in burn wounds
Measured: 28 days
Secondary outcomes (1)
Safety assessed by documentation of adverse events, clinical laboratory results and vital signs
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2016 (estimated)
- Study start21 Jun 2016
- Primary completion28 Feb 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute BurnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mundipharma Korea Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dohern Kim, Dr., Principal investigator, Hangang Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02660541
- Sponsor's protocol ID
- BTF15-KR-401
- Status last verified
- Jan 2018
- First submitted
- 13 Jan 2016
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Compare Efficacy of Allevyn® Silver Dressing and Betafoam® in Patients With Wound of Acute Burn Injury
- ClinicalTrials.gov ID
- NCT02660541
- Acronym / sponsor ID
- BTF15-KR-401
- Conditions
- Acute Burn
- Keywords
- Dressing for burn wounds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Mundipharma Korea LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2016 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 21 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Betafoam | Active comparator | Device: BetafoamBrand name: Betafoam® This is a medicated device (dressing) consisting of 3% povidone iodine. |
| Allevyn Silver dressing | Active comparator | Device: Allevyn Silver DressingBrand name: Allevyn® Silver |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BetafoamComparison between 2 medical devices | Device | Betafoam |
| Allevyn Silver DressingComparison between 2 medical devices | Device | Allevyn Silver dressing |
Primary outcome
Comparison between Betafoam® and Allevyn® Silver dressing, measured by days needed for complete re-epithelialization in burn wounds
Time frame: 28 days
1 secondary outcome
Safety assessed by documentation of adverse events, clinical laboratory results and vital signs
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dohern Kim, Dr. principal investigator
Hangang Sacred Heart Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Betafoam and Allevyn Silver Dressing in people with Acute Burn, run by Mundipharma Korea Ltd at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between Betafoam® and Allevyn® Silver dressing, measured by days needed for complete re-epithelialization in burn wounds (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2018.