Use of Amnion on Partial Thickness Burns

Phase 2

Withdrawn

• Conditions: Burn
• Interventions: Biological: Amnion; Drug: Polysporin/Bacitracin/Mycostatin

• Registration Number: NCT00674999
• Lead Sponsor: The University of Texas Medical Branch, Galveston

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2007-12-26
• Study First Submitted QC: 2008-05-06
• Study First Posted: 2008-05-08
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-13
• Last Update Posted: 2012-11-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

• Patients not expected to survive

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Amnion	Amnion with processing procedures involving the use of trypsin-Edetic Acid(EDTA)
2	Amnion	Amnion with processing procedures involving the use of Dispase II
3	Polysporin/Bacitracin/Mycostatin	Prepared Antibiotic ointment Polysporin, Bacitracin and Mycostatin

Primary Outcome Measures

Name	Time	Method
Length of time to 95% healing of treated burn wounds	Assessment daily until 95 % healed

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	Measured at hospital discharge
Incidence of infection	Measure daily until complete wound healing
Amount of daily pain until wound is healed with different treatments.	Daily until wound is completely healed.
Amount of scaring with different treatments	From injury to 2 years post burn