NCT01062191

Altrazeal Range of Motion Study Comparing With Typical Carboxymethyl

Flexible Hydrogel Nanoparticle Wound Dressing Allows Greater Joint Range of Motion Compared to Typical Sodium Carboxymethylcellulose Dressing

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: ULURU Inc. · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a single center, randomized, single blind therapeutic exploratory study to monitor the range of motion of wounds treated with the new nanoparticle hydrogel dressing compared to the range of motion of wounds treated with existing treatment standard (sodium carboxymethylcellulose dressing) in patients with partial thickness burns. A total of 50 joints will be studied. The patients will be at least 7 years of age.. The Department of Physical Medicine and Rehabilitation at Parkland Hospital and Health System, UT Southwestern, will be asked to enroll enough patients to meet the proposed 50 joint study sites (approximately 3-5 afflicted joints per patient). Children will be included in the patient population if possible. Inclusion criteria for the medical condition will be at least one partial thickness burn that crosses at least one peripheral joint axial to the proximal interphalangeal joints. As a control, the patients will also need to have an unburned contralateral joint without major internal or external joint derangement. The Primary Investigator will first identify the study site and control site for each patient and take the initial measurements. Trained personnel will apply the bandage to the study site. No secondary bandage will be applied. Typical meticulous wound care and adequate analgesic medical coverage will be provided for the duration of the study. Both the patient and medical staff will be trained on patient use instructions for the dressing. The patients will be monitored for a short time after application of the bandage as part of standard procedure, and the patient is then allowed to go home with instructions for care. Within 2-8 days after application, the dressing will be inspected and range of motion will be measured for both the study site and the control site. Any concomitant treatment (medications, wound care) will be thoroughly documented for the duration of the study. Both dressings are designed to remain on the wound until the bandage falls off, which indicates re-epithelialization of the wound. The dressings should not be removed by the patient or medical staff unless there are signs of infection, deterioration of bandage, or other adverse event. If the bandage falls off, the patient is instructed to immediately call the medical staff.

Conditions

• Burn

Interventions

Type	Name	Description
DEVICE	Aquacel AG, typical carboxymethylcellulose dressing	4" X 4", Aquacel silver sheet
DEVICE	Altrazeal Flexible Hydrogel Nanoparticle Wound Dressing	Wound dressing

Timeline

• Start date: 2007-05-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2010-02-04
• Last updated: 2011-06-08

Locations

1 site across 1 country: United States