Use of Amnion on Partial Thickness Burns

This study has been withdrawn prior to enrollment.
(Hurricane- terminated study due to skin bank being destroyed)
Sponsor:
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT00674999
First received: December 26, 2007
Last updated: November 13, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Burn
Biological: Amnion
Drug: Polysporin/Bacitracin/Mycostatin
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Project Title The Treatment of Partial Thickness Burns: Treated Amnion Versus Currently in Use Topical Medications

Resource links provided by NLM:


Further study details as provided by The University of Texas, Galveston:

Primary Outcome Measures:
  • Length of time to 95% healing of treated burn wounds [ Time Frame: Assessment daily until 95 % healed ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Length of hospital stay [ Time Frame: Measured at hospital discharge ] [ Designated as safety issue: No ]
  • Incidence of infection [ Time Frame: Measure daily until complete wound healing ] [ Designated as safety issue: Yes ]
  • Amount of daily pain until wound is healed with different treatments. [ Time Frame: Daily until wound is completely healed. ] [ Designated as safety issue: No ]
  • Amount of scaring with different treatments [ Time Frame: From injury to 2 years post burn ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: June 2005
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Amnion with processing procedures involving the use of trypsin-Edetic Acid(EDTA)
Biological: Amnion
Application of Amnion with processing procedures involving the use of trypsin-EDTA
Experimental: 2
Amnion with processing procedures involving the use of Dispase II
Biological: Amnion
Application of Amnion with processing procedures involving the use of Dispase II
Active Comparator: 3
Prepared Antibiotic ointment Polysporin, Bacitracin and Mycostatin
Drug: Polysporin/Bacitracin/Mycostatin
Application of Prepared antibiotic ointment: Polysporin, Bacitracin and Mycostatin combined

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients not expected to survive
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00674999

Sponsors and Collaborators
The University of Texas, Galveston
Investigators
Principal Investigator: David N Herndon, MD University of Texas
  More Information

No publications provided

Responsible Party: The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT00674999     History of Changes
Other Study ID Numbers: 05-040
Study First Received: December 26, 2007
Last Updated: November 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas, Galveston:
Burn
Partial thickness burn

Additional relevant MeSH terms:
Burns
Wounds and Injuries
Bacitracin
Nystatin
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Bacterial Agents
Antifungal Agents
Ionophores
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014