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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
Mundipharma Korea Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Burn focused on measuring Dressing for burn wounds

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

First Posted
January 13, 2016
Last Updated
January 25, 2018
Sponsor
Mundipharma Korea Ltd
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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

Learn more about this trial

Burn Wound Management of Betafoam® and Allevyn® Ag

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