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Use of Amnion on Partial Thickness Burns

Information source: The University of Texas, Galveston
Information obtained from ClinicalTrials.gov on October 19, 2009
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: Recruiting

Sponsored by: The University of Texas, Galveston

Official(s) and/or principal investigator(s):
David N Herndon, MD, Principal Investigator, Affiliation: University of Texas

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

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

Primary outcome: Length of time to 95% healing of treated burn wounds

Secondary outcome:

Length of hospital stay

Incidence 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

David N Herndon, MD, Phone: 409-770-6731, Email: dherndon@utmb.edu

University of Texas Medical Branch, Galveston, Texas 77550, United States; Recruiting
Deb A Benjamin, RN, MSN, Phone: 409-770-6731, Email: dbenjami@utmb.edu
Carole J Miller, Phone: 409-770-6728, Email: cmiller@utmb.edu
David N Herndon, MD, Principal Investigator
Additional Information

Starting date: June 2005
Ending date: December 2014
Last updated: February 17, 2009

Page last updated: October 19, 2009

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