NCT00674999

Brief Summary

To determine if Amnion, used on partial thickness burn injuries would provide an improvement in rate of healing, pain control and scarring as compared to standard medical treatments.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2005

Typical duration for phase_2

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withdrawn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

Study Start

First participant enrolled

June 1, 2005

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 8, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

November 15, 2012

Status Verified

November 1, 2012

Enrollment Period

3.3 years

First QC Date

December 26, 2007

Last Update Submit

November 13, 2012

Conditions

Burn

Keywords

BurnPartial thickness burn

Outcome Measures

Primary Outcomes (1)

  • Length of time to 95% healing of treated burn wounds

    Assessment daily until 95 % healed

Secondary Outcomes (4)

  • Length of hospital stay

    Measured at hospital discharge

  • Incidence of infection

    Measure daily until complete wound healing

  • Amount of daily pain until wound is healed with different treatments.

    Daily until wound is completely healed.

  • Amount of scaring with different treatments

    From injury to 2 years post burn

Study Arms (3)

1

EXPERIMENTAL

Amnion with processing procedures involving the use of trypsin-Edetic Acid(EDTA)

Biological: Amnion

2

EXPERIMENTAL

Amnion with processing procedures involving the use of Dispase II

Biological: Amnion

3

ACTIVE COMPARATOR

Prepared Antibiotic ointment Polysporin, Bacitracin and Mycostatin

Drug: Polysporin/Bacitracin/Mycostatin

Interventions

AmnionBIOLOGICAL

Application of Amnion with processing procedures involving the use of trypsin-EDTA

1
Polysporin/Bacitracin/MycostatinDRUG

Application of Prepared antibiotic ointment: Polysporin, Bacitracin and Mycostatin combined

3

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Partial thickness burn injury.
  • \>2% burn injury.
  • Ages 0-100 years.

You may not qualify if:

  • Patients not expected to survive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Burns

Interventions

cancer procoagulantbacitracin, polymyxin B drug combination

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • David N Herndon, MD

    University of Texas

    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

December 26, 2007

First Posted

May 8, 2008

Study Start

June 1, 2005

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

November 15, 2012

Record last verified: 2012-11