Burn Wound Management of Betafoam® and Allevyn® Ag | NCT02660541

Studies
Burn Wound Management of Betafoam® and Allevyn® Ag

NCT02660541

Sponsor

Mundipharma Korea Ltd

Status

Completed

Last Update Posted

Jan 26, 2018Actual

Enrollment

32Actual

Phase

Not Applicable

Conditions

Acute Burn

Interventions

Betafoam
Allevyn Silver Dressing

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 21, 2016Actual

Primary Completion Date

Feb 28, 2017Actual

Completion Date

May 2017Actual

First Submitted Date

Jan 13, 2016

First Submission Date that Met QC Criteria

Jan 20, 2016

First Posted Date

Jan 21, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2018

Last Update Posted Date

Jan 26, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Betafoam	Active Comparator	Brand name: Betafoam® This is a medicated device (dressing) consisting of 3% povidone iodine.	Device: Betafoam
Allevyn Silver dressing	Active Comparator	Brand name: Allevyn® Silver	Device: Allevyn Silver Dressing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Betafoam	Device	Comparison between 2 medical devices	Betafoam
Allevyn Silver Dressing

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

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

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided