Altrazeal™ Versus Aquacel® Ag for Partial Thickness Skin Donor Sites
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.
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 Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Partial-thickness Skin Donor Sites
Intervention
Altrazeal, Aquacel Ag
Location
University of Texas Southwestern Medical Center
Dallas
Texas
United States
75390-9158
Status
Completed
Source
ULURU
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01062204
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Skinfold Thickness
The measurement of subcutaneous fat located directly beneath the skin by grasping a fold of skin and subcutaneous fat between the thumb and forefinger and pulling it away from the underlying muscle tissue. The thickness of the double layer of skin and subcutaneous tissue is then read with a caliper. The five most frequently measured sites are the upper arm, below the scapula, above the hip bone, the abdomen, and the thigh. Its application is the determination of relative fatness, of changes in physical conditioning programs, and of the percentage of body fat in desirable body weight. (From McArdle, et al., Exercise Physiology, 2d ed, p496-8)
Nuchal Translucency Measurement
A prenatal ultrasonic measurement of the thickness or translucent area below the SKIN in the back of the fetal NECK, or nape of the neck, during the first 11-14 weeks of gestation (PREGNANCY TRIMESTER, FIRST). Abnormal thickness or nuchal translucent measurements resulting from fluid collection, is associated with increased risks of CHROMOSOME ABNORMALITIES. (Nicolaides et al., 1992)
Epilepsy, Partial, Sensory
A disorder characterized by recurrent focal onset seizures which have sensory (i.e., olfactory, visual, tactile, gustatory, or auditory) manifestations. Partial seizures that feature alterations of consciousness are referred to as complex partial seizures (EPILEPSY, COMPLEX PARTIAL).
Epilepsies, Partial
Conditions characterized by recurrent paroxysmal neuronal discharges which arise from a focal region of the brain. Partial seizures are divided into simple and complex, depending on whether consciousness is unaltered (simple partial seizure) or disturbed (complex partial seizure). Both types may feature a wide variety of motor, sensory, and autonomic symptoms. Partial seizures may be classified by associated clinical features or anatomic location of the seizure focus. A secondary generalized seizure refers to a partial seizure that spreads to involve the brain diffusely. (From Adams et al., Principles of Neurology, 6th ed, pp317)
Celiprolol
A cardioselective beta-1-adrenergic antagonist that may act as a partial agonist at some adrenergic sites.
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