Use of Amnion on Partial Thickness Burns

Burn Clinical Trial

— Amnion  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00674999
• Other study ID #: 05-040
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: December 26, 2007
• Last updated: November 13, 2012
• Start date: June 2005
• Est. completion date: September 2008

Study information

• Verified date: November 2012
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Partial thickness burn injury.

• >2% burn injury.

• Ages 0-100 years.

Exclusion Criteria:

• Patients not expected to survive

Study Design

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

Related Conditions & MeSH terms

• Burn
• Burns

Intervention

Biological:
• Amnion
Application of Amnion with processing procedures involving the use of trypsin-EDTA
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of time to 95% healing of treated burn wounds		Assessment daily until 95 % healed	No
Secondary	Length of hospital stay		Measured at hospital discharge	No
Secondary	Incidence of infection		Measure daily until complete wound healing	Yes
Secondary	Amount of daily pain until wound is healed with different treatments.		Daily until wound is completely healed.	No
Secondary	Amount of scaring with different treatments		From injury to 2 years post burn	No