Use of Amnion on Partial Thickness Burns

Verified by: The University of Texas, Galveston, June 2011
First Received: December 26, 2007 | Last Updated: June 21, 2011 | Phase: Phase 2/Phase 3 | Start Date: June 2005
Overall Status: Recruiting | Estimated Enrollment: 90
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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...

Brief Summary

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
  • 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

Outcome Measures for this Clinical Trial

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

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: The University of Texas, Galveston Other

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

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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

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