Burn Clinical Trial
— ROMOfficial title:
Flexible Hydrogel Nanoparticle Wound Dressing Allows Greater Joint Range of Motion Compared to Typical Sodium Carboxymethylcellulose Dressing
Verified date | June 2011 |
Source | ULURU |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 3 |
Est. completion date | October 2008 |
Est. primary completion date | October 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 2 Years and older |
Eligibility |
Inclusion Criteria: 1. Male or female patient is at least 2 years of age; 2. Patient is in general good health; 3. Patient has partial thickness burn that crosses at least one peripheral joint axial to the proximal interphalangeal joints; 4. Patient has one unburned contralateral joint without major internal or external joint derangement to be used as control 5. Patient is willing and able to cooperate with the protocol for 30 days 6. Patient is capable of provided informed consent 7. Patient provides authorization for use and disclosure of protected health information Exclusion Criteria: 1. Age less than 2 years; 2. Patient has superficial or full thickness burn wounds; 3. Patient has acutely infected wounds; 4. Patient has wounds with surrounding cellulites; 5. 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 6. 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; 7. Patient is wearing any type of orthopedic device that may come in contact with the dressing; 8. 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 9. Patient has wound originating from chronic condition 10. Patients with history of any immunodeficiency syndrome or condition 11. Patients who have applied any dressing or medication (OTC or prescription) to the wound (within 48 hours of study? ) 12. Patient has participated in a clinical research study within the last 30 days prior to enrollment; 13. Patient is unable to communicate or to cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | UT Southwestern | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
ULURU |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Range of motion in burned joints with dressing in place as compared to control | Up to 2 weeks | No | |
Secondary | Pain at joint with dressing in place | up to 2 weeks | Yes |
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