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OpenTrials
Completed

NCT Number: NCT02660541

Burn Wound Management of Betafoam® and Allevyn® Ag

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.

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Key information

Conditions

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hallym University Hangang Sacred Heart Hospital

Seoul, 150719, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Betafoam

Device

Comparison between 2 medical devices

Allevyn Silver Dressing

Device

Comparison between 2 medical devices

Primary outcomes

  1. Comparison between Betafoam® and Allevyn® Silver dressing, measured by days needed for complete re-epithelialization in burn wounds

    Time frame: 28 days

Secondary outcomes

  1. Safety assessed by documentation of adverse events, clinical laboratory results and vital signs

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Mundipharma Korea Ltd

Industry

Registry information

Official study title

A Pilot Study to Compare Efficacy of Allevyn® Silver Dressing and Betafoam® in Patients With Wound of Acute Burn Injury

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 21, 2016
Registry last updated
Jan 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.