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

NCT ID: NCT01062204

Last Updated: 2010-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2009-12-31

Brief Summary

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.

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.

Conditions

Partial-thickness Skin Donor Sites

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Altrazeal

Sterile, odorless, crystalline white powder consisting of flakes of freeze dried HEMA and HPMA polymers. For application, the powder is distributed to the surface of the wound or burn where it forms a moist, flexible film and adheres to the surface of the wound.

Intervention Type: DEVICE

Aquacel Ag

Textile fiber made from sodium carboxy-methylcellulose containing 1.2% silver in ionic form.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ULURU Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

UTSW Medical Center, Department of Surgery

Locations

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

UC-6U1102

Identifier Type: -

Identifier Source: org_study_id