NCT00847496

Brief Summary

• To determine if AWBAT, used in treating partial-thickness burns, would provide better healing, pain control, control of infection, shorter length of hospital stay, lower costs, and improved scarring and long term recovery when compared to Biobrane®.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

1 active site

Status
withdrawn

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

February 17, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 19, 2009

Completed
10 months until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

December 11, 2012

Status Verified

December 1, 2012

Enrollment Period

2.7 years

First QC Date

February 17, 2009

Last Update Submit

December 10, 2012

Conditions

Burns

Keywords

Partial Thickness burnBiological Dressing

Outcome Measures

Primary Outcomes (1)

  • Time to complete Healing

    5 - 14 days post injury/membrane application

Secondary Outcomes (1)

  • Occurence of Infection

    entire study period

Study Arms (2)

1

EXPERIMENTAL

AWBAT

Device: AWBAT

2

ACTIVE COMPARATOR

BIOBRANE(R)

Device: Biobrane

Interventions

AWBATDEVICE

One-time application of dressing over partial-thickness burns

1
BiobraneDEVICE

One-time application over partial-thickness burns

2

Eligibility Criteria

Age3 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Partial thickness burns between 4% and 40% Total Body Surface Area(TBSA)
  • Full thickness burns not to exceed 10% TBSA,
  • Age as specified

You may not qualify if:

  • Full thickness burns that require immediate excision and grafting
  • Known allergic reaction against Biobrane
  • Chemical and electrical burns

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shriners Hospital for Children

Galveston, Texas, 77550, United States

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • David N Herndon, MD

    Shriners Hospital for Children and University of Texas Medical Branch

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2009

First Posted

February 19, 2009

Study Start

December 1, 2009

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

December 11, 2012

Record last verified: 2012-12

Locations

US(1)