Altrazeal Range of Motion Study Comparing With Typical Carboxymethyl

Stopped early · Not applicable

Conditions studied: Burn

In brief

The objective of this study is to evaluate the difference in joint range of motion of a new flexible hydrogel nanoparticle wound dressing compared to typical sodium carboxymethylcellulose dressing Aquacel AG for treatment of partial thickness burns.

Key facts

Study ID

NCT01062191

Run by

ULURU Inc.

People needed

3

Starts

2007-05-01

Expected to finish

2008-10-01

Last updated by the study team

2011-06-08

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female patient is at least 2 years of age;
• Patient is in general good health;
• Patient has partial thickness burn that crosses at least one peripheral joint axial to the proximal interphalangeal joints;
• Patient has one unburned contralateral joint without major internal or external joint derangement to be used as control
• Patient is willing and able to cooperate with the protocol for 30 days
• Patient is capable of provided informed consent
• Patient provides authorization for use and disclosure of protected health information

You may not qualify if…

• Age less than 2 years;
• Patient has superficial or full thickness burn wounds;
• 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 hydrocellulose dressing, or any know sensitivities to other hydrogel bandage treatments
• Patient has a concurrent clinical condition, which in the judgment of the Investigator cold either pose a health risk to the patient while participating in this study, or could potentially influence the outcome of the study;
• Patient is wearing any type of orthopedic device that may come in contact with the dressing;
• Patient has history of poor wound healing, history of smoking, history of drug/alcohol abuse, any other skin/immune system condition that would increase likelihood of wound irritation, infection or increase chance of early termination
• Patient has wound originating from chronic condition
• Patients with history of any immunodeficiency syndrome or condition
• Patients who have applied any dressing or medication (OTC or prescription) to the wound (within 48 hours of study? )
• Patient has participated in a clinical research study within the last 30 days prior to enrollment;
• 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

• UT Southwestern — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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