Altrazeal™ Versus Aquacel® Ag for Partial Thickness Skin Donor Sites

February 3, 2010 updated by: ULURU Inc.

A Randomized Comparison Study of a Flexible HydrogelNanoparticle Wound Dressing (Altrazeal) Versus a Sodium Carboxymethylcellulose Dressing (Aquacel Ag) as Dressings for Partial Thickness Skin Graft Donor Sites

The primary objective of the study is to evaluate the time to wound healing in skin graft donor sites with a new treatment (Altrazeal dressing) compared to standard of care treatment (Aquacel Ag- Carboxymethylcellulose dressing) in partial thickness skin graft donor sites.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a single center, randomized, therapeutic exploratory study to monitor wound healing with the new AltrazealTM flexible hydrogel nanoparticle dressing compared to the existing treatment standard (Aquacel ® AG sodium carboxymethylcellulose dressing) in patients with at least two skin graft donor sites. 40 patients with at least 2 skin graft donor sites, ranging in age from 3 and 85 years, will be enrolled. Children (age 3 to 16 inclusive) will be included in the patient population if possible, but should not exceed 50% of all patient enrolled. Researchers will first identify the skin donor sites (A and B) for each patient and take baseline digital images and measurements immediately following surgery (Day 1). Trained personnel will apply the dressings provided by the Sponsor for and labeled as A or B by the Sponsor in a random fashion. 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 instructions for use of each dressing. The patients will be monitored daily as part of standard procedure while they are in the in-patient setting. If and when patients move to the out-patient setting, they will continue to be monitored at least every-other-day at the study center. On each day (in-patient) or every-other-day (outpatient), the physician will determine whether each skin graft donor site has healed per standard care guidelines (i.e. > 95% re-epithelization), and pain and adverse events will be monitored. The last study visit will be on Day 24 or on the day when both wounds have been assessed as "healed", whichever comes first.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390-9158
        • University of Texas Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 85 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female patient is between the ages of 3 and 85 Note: In order to maintain a broad representation of ages, no more than 50% of the patients enrolled in the study should be between the ages of 3 and 16, inclusive.
  2. Patient is in general good health
  3. Patient has two independent skin donor sites of approximately the same dimensions.
  4. Patient is willing and able to cooperate with the protocol for duration of study.
  5. Patient is capable of providing informed consent and HIPAA authorization
  6. Ability to read and speak either English or Spanish

Exclusion Criteria:

  1. Male or female patient is less than 3 years of age or more than 85 years of age
  2. Patient has acutely infected wounds
  3. Patient has wounds with surrounding cellulites
  4. Patient has a history of hypersensitivity to any components of either the nanoparticle or sodium carboxymethylcellulose dressing, or any known sensitivities to other hydrogel bandage treatments
  5. Patient has a concurrent clinical condition, which in the judgment of the Investigator could either pose a health risk to the patient while participating in this study, or could potentially influence the outcome of the study;
  6. Patient has history of poor wound healing or any skin/immune system condition that would increase likelihood of wound irritation, infection or increase chance of early termination
  7. Patient is unable to communicate or to cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Time to wound healing (re-epithelialization), in days assessed by the physician according to the study center's Standard of Care, for each wound dressing.
Time Frame: 24 days
24 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Patient's comfort
Time Frame: 24 days
24 days
Patient's pain
Time Frame: 24 days
24 days
Infections
Time Frame: 24 days
24 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ULURU Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 4, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 4, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UC-6U1102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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