Altrazeal Range of Motion Study Comparing With Typical Carboxymethyl

NCT01062191 | Terminated DMC

• 1 other identifier: U-C-6U1101
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Burn

Keywords

hydrogel; dressing; burn; joint

Outcome Measures

Primary Outcomes (1)

• Range of motion in burned joints with dressing in place as compared to control

  Up to 2 weeks

Secondary Outcomes (1)

• Pain at joint with dressing in place

  up to 2 weeks

Study Arms (2)

Altrazeal Flexible Hydrogel Nanoparticle Wound Dressing

EXPERIMENTAL

Nanoflex Powder Dressing applied to joint

Device: Altrazeal Flexible Hydrogel Nanoparticle Wound Dressing

Aquacel AG, typical carboxymethylcellulose dressing

ACTIVE COMPARATOR

Sodium CMC dressing control applied to joint

Device: Aquacel AG, typical carboxymethylcellulose dressing

Interventions

Aquacel AG, typical carboxymethylcellulose dressing DEVICE

4" X 4", Aquacel silver sheet

Aquacel AG, typical carboxymethylcellulose dressing

Altrazeal Flexible Hydrogel Nanoparticle Wound Dressing DEVICE

Wound dressing

Altrazeal Flexible Hydrogel Nanoparticle Wound Dressing

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• ULURU Inc.: lead

Study Sites (1)

UT Southwestern

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 2, 2010
• First Posted: February 4, 2010
• Study Start: May 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: June 8, 2011

Record last verified: 2011-06

Locations

US (1)