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

Launched by ULURU INC. · Feb 3, 2010

Keywords

ClinConnect Summary

This is a single center, randomized, therapeutic exploratory study to monitor wound healing with the new AltrazealTM flexible hydrogel nanoparticle dressing compared to the existing treatment standard (Aquacel ® AG sodium carboxymethylcellulose dressing) in patients with at least two skin graft donor sites. 40 patients with at least 2 skin graft donor sites, ranging in age from 3 and 85 years, will be enrolled. Children (age 3 to 16 inclusive) will be included in the patient population if possible, but should not exceed 50% of all patient enrolled. Researchers will first identify the skin d...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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.
• • 2. Patient is in general good health
• • 3. Patient has two independent skin donor sites of approximately the same dimensions.
• • 4. Patient is willing and able to cooperate with the protocol for duration of study.
• • 5. Patient is capable of providing informed consent and HIPAA authorization
• • 6. Ability to read and speak either English or Spanish
• Exclusion Criteria:
• • 1. Male or female patient is less than 3 years of age or more than 85 years of age
• • 2. Patient has acutely infected wounds
• • 3. Patient has wounds with surrounding cellulites
• • 4. 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
• • 5. 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;
• • 6. 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
• • 7. Patient is unable to communicate or to cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.