NCT01067729

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.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

3 active sites

Status
terminated

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

Study Start

First participant enrolled

November 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Last Updated

January 26, 2015

Status Verified

February 1, 2010

Enrollment Period

1.6 years

First QC Date

February 10, 2010

Last Update Submit

January 23, 2015

Conditions

Burns

Keywords

BurnSuperficial burnsPartial thickness burnsRate of healingInfection ratePain perceptionNon adherenceScarring

Outcome Measures

Primary Outcomes (1)

  • Rate of healing

    Day 14

Secondary Outcomes (1)

  • Scarring

    6 months, 1 year, 18 months and 2 years

Interventions

AWBAT Wound DressingDEVICE
Also known as: Biobrane
AWBAT™, Biobrane®DEVICE

Comparison of burn dressings on randomized body sites using patient as own control

Eligibility Criteria

Age1 Year - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

UC Irvine Burn Center

Irvine, California, 92868, United States

Location

University of Missouri Health Care

Columbia, Missouri, 65212, United States

Location

Shriners Hospitals for Children

Galveston, Texas, 77550, United States

Location

MeSH Terms

Conditions

BurnsCicatrix

Condition Hierarchy (Ancestors)

Wounds and InjuriesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 10, 2010

First Posted

February 12, 2010

Study Start

November 1, 2009

Primary Completion

June 1, 2011

Last Updated

January 26, 2015

Record last verified: 2010-02

Locations

US(3)