Altrazeal™ Versus Aquacel® Ag for Partial Thickness Skin Donor Sites

Completed · Not applicable

Conditions studied: Partial-thickness Skin Donor Sites

In brief

The primary objective of the study is to evaluate the time to wound healing in skin graft donor sites with a new treatment (Altrazeal dressing) compared to standard of care treatment (Aquacel Ag- Carboxymethylcellulose dressing) in partial thickness skin graft donor sites.

Key facts

Study ID

NCT01062204

Run by

ULURU Inc.

People needed

40

Starts

2008-05-01

Expected to finish

2009-12-01

Last updated by the study team

2010-02-04

Who can join

Age: 3 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patient is between the ages of 3 and 85 Note: In order to maintain a broad representation of ages, no more than 50% of the patients enrolled in the study should be between the ages of 3 and 16, inclusive.
• Patient is in general good health
• Patient has two independent skin donor sites of approximately the same dimensions.
• Patient is willing and able to cooperate with the protocol for duration of study.
• Patient is capable of providing informed consent and HIPAA authorization
• Ability to read and speak either English or Spanish

You may not qualify if…

• Male or female patient is less than 3 years of age or more than 85 years of age
• Patient has acutely infected wounds
• Patient has wounds with surrounding cellulites
• Patient has a history of hypersensitivity to any components of either the nanoparticle or sodium carboxymethylcellulose dressing, or any known sensitivities to other hydrogel bandage treatments
• Patient has a concurrent clinical condition, which in the judgment of the Investigator could either pose a health risk to the patient while participating in this study, or could potentially influence the outcome of the study;
• Patient has history of poor wound healing or any skin/immune system condition that would increase likelihood of wound irritation, infection or increase chance of early termination
• Patient is unable to communicate or to cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.

Where it is running

• University of Texas Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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