Official Title: “Project Title The Treatment of Partial Thickness Burns: Treated Amnion Versus Currently in Use Topical Medications”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2012

Intervention(s) in this Clinical Trial

• Biological: Amnion
  • Application of Amnion with processing procedures involving the use of trypsin-EDTA
• Biological: Amnion
  • Application of Amnion with processing procedures involving the use of Dispase II
• Drug: Polysporin/Bacitracin/Mycostatin
  • Application of Prepared antibiotic ointment: Polysporin, Bacitracin and Mycostatin combined

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Amnion with processing procedures involving the use of trypsin-EDTA
• Experimental: 2
  • Amnion with processing procedures involving the use of Dispase II
• Active Comparator: 3
  • Prepared Antibiotic ointment Polysporin, Bacitracin and Mycostatin

Primary Measures

• Length of time to 95% healing of treated burn wounds
  • Time Frame: Assessment daily until 95 % healed
    Safety Issue?: No

Secondary Measures

• Length of hospital stay
  • Time Frame: Measured at hospital discharge
    Safety Issue?: No
• Incidence of infection
  • Time Frame: Measure daily until complete wound healing
    Safety Issue?: Yes
• Amount of daily pain until wound is healed with different treatments.
  • Time Frame: Daily until wound is completely healed.
    Safety Issue?: No
• Amount of scaring with different treatments
  • Time Frame: From injury to 2 years post burn
    Safety Issue?: No

Inclusion Criteria:

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

Exclusion Criteria:

• Patients not expected to survive

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: The University of Texas, Galveston

Overall Clinical Trial Officials and Contacts

David N Herndon, MD Principal Investigator University of Texas  

Overall Contact: David N Herndon, MD 409-770-6731 dherndon@utmb.edu

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00674999

Study ID Number: 05-040

ClinicalTrials.gov Identifier: NCT00674999

Health Authority: United States: Institutional Review Board