NCT02660541

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 21, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

June 21, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

January 26, 2018

Status Verified

January 1, 2018

Enrollment Period

8 months

First QC Date

January 13, 2016

Last Update Submit

January 25, 2018

Conditions

Acute Burn

Keywords

Dressing for burn wounds

Outcome Measures

Primary Outcomes (1)

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

    28 days

Secondary Outcomes (1)

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

    28 days

Study Arms (2)

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

BetafoamDEVICE

Comparison between 2 medical devices

Betafoam
Allevyn Silver DressingDEVICE

Comparison between 2 medical devices

Allevyn Silver dressing

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults ≥ 19 years
  • Subjects of second-degree burn who have acute partial thickness burn (superficial to deep partial thickness) via investigator's visible assessment
  • Subjects who voluntarily sign the informed consent form

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hallym University Hangang Sacred Heart Hospital

Seoul, 150719, South Korea

Location

Study Officials

  • Dohern Kim, Dr.

    Hangang Sacred Heart Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2016

First Posted

January 21, 2016

Study Start

June 21, 2016

Primary Completion

February 28, 2017

Study Completion

May 1, 2017

Last Updated

January 26, 2018

Record last verified: 2018-01

Locations

KR(1)