Altrazeal Range of Motion Study Comparing With Typical Carboxymethyl (ROM)

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

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.

Study Overview

• Status: Terminated
• Conditions: Burn
• Intervention / Treatment: Device: Altrazeal Flexible Hydrogel Nanoparticle Wound Dressing; Device: Aquacel AG, typical carboxymethylcellulose dressing

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Altrazeal Flexible Hydrogel Nanoparticle Wound Dressing; Nanoflex Powder Dressing applied to joint	Device: Altrazeal Flexible Hydrogel Nanoparticle Wound Dressing; Wound dressing
Active Comparator: Aquacel AG, typical carboxymethylcellulose dressing; Sodium CMC dressing control applied to joint	Device: Aquacel AG, typical carboxymethylcellulose dressing; 4" X 4", Aquacel silver sheet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Range of motion in burned joints with dressing in place as compared to control	Up to 2 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Pain at joint with dressing in place	up to 2 weeks

Collaborators and Investigators

• Sponsor: ULURU Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: February 2, 2010
• First Submitted That Met QC Criteria: February 3, 2010
• First Posted (Estimate): February 4, 2010

Study Record Updates

• Last Update Posted (Estimate): June 8, 2011
• Last Update Submitted That Met QC Criteria: June 7, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: hydrogel; dressing; joint; burn
• Additional Relevant MeSH Terms: Gastrointestinal Agents; Laxatives; Carboxymethylcellulose Sodium
• Other Study ID Numbers: U-C-6U1101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No