Burn Wound Management of Betafoam® and Allevyn® Ag

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.

Study Overview

• Status: Completed
• Conditions: Acute Burn
• Intervention / Treatment: Device: Betafoam; Device: Allevyn Silver Dressing

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 150719
    • Hallym University Hangang Sacred Heart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Betafoam; Brand name: Betafoam® This is a medicated device (dressing) consisting of 3% povidone iodine.	Device: Betafoam; Comparison between 2 medical devices
Active Comparator: Allevyn Silver dressing; Brand name: Allevyn® Silver	Device: Allevyn Silver Dressing; Comparison between 2 medical devices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comparison between Betafoam® and Allevyn® Silver dressing, measured by days needed for complete re-epithelialization in burn wounds	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety assessed by documentation of adverse events, clinical laboratory results and vital signs	28 days

Collaborators and Investigators

• Sponsor: Mundipharma Korea Ltd
• Investigators: Principal Investigator: Dohern Kim, Dr., Hangang Sacred Heart Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2016
• Primary Completion (Actual): February 28, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: January 13, 2016
• First Submitted That Met QC Criteria: January 20, 2016
• First Posted (Estimate): January 21, 2016

Study Record Updates

• Last Update Posted (Actual): January 26, 2018
• Last Update Submitted That Met QC Criteria: January 25, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Dressing for burn wounds
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: BTF15-KR-401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED