A Postmarket Randomized Study of the Treatment of Superfi... | NCT01067729

Studies
A Postmarket Randomized Study of the Treatment of Superficial Partial-Thickness Burns Using Two Dressings

NCT01067729

Sponsor

Aubrey Inc.

Status

Terminated

Last Update Posted

Jan 26, 2015Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Burns

Interventions

AWBAT Wound Dressing
AWBAT™, Biobrane®

Countries

United States

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

Feb 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Jun 2011Actual

Completion Date

Not provided

First Submitted Date

Feb 10, 2010

First Submission Date that Met QC Criteria

Feb 11, 2010

First Posted Date

Feb 12, 2010Estimated

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 23, 2015

Last Update Posted Date

Jan 26, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Description Module

Brief Summary

The purpose of this research study is to compare the rate of healing, the infection or complication rate, pain perception and scarring from burn injuries using two types of burn dressings.

Detailed Description

The purpose of this study is to evaluate AWBAT™ compared to Biobrane® for the treatment of superficial partial-thickness burns using the patient as their own control.

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

Not provided

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AWBAT Wound Dressing	Device			Biobrane
AWBAT™, Biobrane®	Device	Comparison of burn dressings on randomized body sites using patient as own control

Measure	Description	Time Frame
Rate of healing		Day 14

Measure	Description	Time Frame
Scarring		6 months, 1 year, 18 months and 2 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Superficial partial thickness burns
Two non-contiguous burn sites or the same approximate size/depth for comparison, OR
One burn site large enough to accommodate both a 6" square AWBAT™ dressing and a 6 " square Biobrane® dressing
Burn wounds measuring >2% - <40% TBSA
Patient age: >1 - 70 years

Exclusion Criteria:

Ventilator dependence
Pregnancy/Lactation
Mechanism of injury was electrical, chemical or frostbite
Co-morbidity which may compromise healing
Known allergy to porcine or porcine products

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UC Irvine Burn Center		Irvine	California	92868	United States
University of Missouri Health Care

Condition Browse Module

MeSH Terms

ID	Term
D002056	Burns
D002921	Cicatrix

Ancestor Terms

ID	Term
D014947	Wounds and Injuries
D005355	Fibrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided