Use of Amnion on Partial Thickness Burns
Information source: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Burn
Intervention: Amnion (Biological); Amnion (Biological); Polysporin/Bacitracin/Mycostatin (Drug)
Phase: Phase 2/Phase 3
Status: Withdrawn
Sponsored by: The University of Texas Medical Branch, Galveston Official(s) and/or principal investigator(s):
David N Herndon, MD, Principal Investigator, Affiliation: University of Texas
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.
Clinical Details
Official title: Project Title The Treatment of Partial Thickness Burns: Treated Amnion Versus Currently in Use Topical Medications
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Length of time to 95% healing of treated burn wounds
Secondary outcome: Length of hospital stayIncidence of infection Amount of daily pain until wound is healed with different treatments. Amount of scaring with different treatments
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Partial thickness burn injury.
- >2% burn injury.
- Ages 0-100 years.
Exclusion Criteria:
- Patients not expected to survive
Locations and Contacts
Additional Information
Starting date: June 2005
Last updated: November 13, 2012
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