Use of Amnion on Partial Thickness Burns

The University of Texas System (UT)

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Burn

Treatments: Drug: Polysporin/Bacitracin/Mycostatin; Biological: Amnion

Study type: Interventional

Funder types: Other

Identifiers

NCT00674999

05-040

Details and patient eligibility

About

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.

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Patients not expected to survive

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

1

Experimental group

Description:

Amnion with processing procedures involving the use of trypsin-Edetic Acid(EDTA)

Treatment:

Biological: Amnion

Biological: Amnion

2

Experimental group

Description:

Amnion with processing procedures involving the use of Dispase II

Treatment:

Biological: Amnion

Biological: Amnion

3

Active Comparator group

Description:

Prepared Antibiotic ointment Polysporin, Bacitracin and Mycostatin

Treatment:

Drug: Polysporin/Bacitracin/Mycostatin