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

NCT01062204 | Completed DMC

• 1 other identifier: UC-6U1102
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Partial-thickness Skin Donor Sites

Keywords

Skin Graft donor sites

Outcome Measures

Primary Outcomes (1)

• Time to wound healing (re-epithelialization), in days assessed by the physician according to the study center's Standard of Care, for each wound dressing.

  24 days

Secondary Outcomes (3)

• Patient's comfort

  24 days

• Patient's pain

  24 days

• Infections

  24 days

Interventions

Altrazeal DEVICE

Sterile, odorless, crystalline white powder consisting of flakes of freeze dried HEMA and HPMA polymers. For application, the powder is distributed to the surface of the wound or burn where it forms a moist, flexible film and adheres to the surface of the wound.

Aquacel Ag DEVICE

Textile fiber made from sodium carboxy-methylcellulose containing 1.2% silver in ionic form.

Eligibility Criteria

• Age: 3 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• ULURU Inc.: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-9158, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 2, 2010
• First Posted: February 4, 2010
• Study Start: May 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: February 4, 2010

Record last verified: 2010-02

Locations

US (1)