Comparative Evaluation of Two AQUACEL Ag Protocols of Care for the Management of Donor Sites
Summary
This phase IIIb, randomized, comparative, multi-center study is designed to evaluate two AQUACEL Ag protocols of care for the management of split-thickness donor sites. Both protocols of care will utilize AQUACEL Ag as the primary dressing. As per the randomization assignment, one protocol of care will have the AQUACEL Ag initially covered with a gauze dressing to create an adherent state and in the other protocol of care the AQUACEL Ag will be covered with a transparent film to maintain a gelled state.
The primary objective of the study will be to quantify the proportion of subjects healed at 14 days. Secondary objectives will include: time to healing, degree of pain at dressing change and while wearing the dressing, simplicity of use, resources used in treatment and safety. Approximately 68 subjects will be enrolled from 10 centers from within the US and Canada.
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Split-Thickness Donor Sites.
Intervention
Aquacel Ag Gelled, Aquacel Ag Adherent
Location
Maricopa Medical Center
Phoenix
Arizona
United States
85008
Status
Completed
Source
ConvaTec Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00731367
- 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)
Microscopy, Interference
The science and application of a double-beam transmission interference microscope in which the illuminating light beam is split into two paths. One beam passes through the specimen while the other beam reflects off a reference mirror before joining and interfering with the other. The observed optical path difference between the two beams can be measured and used to discriminate minute differences in thickness and refraction of non-stained transparent specimens, such as living cells in culture.
Split-brain Procedure
Complete severing of the CORPUS CALLOSUM. In humans it is usually performed to treat medically intractable, multifocal EPILEPSY. EXPERIMENTAL ANIMAL MODELS of split brain preparations are used in research.
Syndecan-4
A ubiquitously expressed syndecan that is found in all stages of embryonic development and in most adult tissues. Syndecan-4 is found localized to focal adhesion sites in fibronectin-adherent cells and may play a role the process of CELL MIGRATION and CELL PROLIFERATION.
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)
Clinical Trials
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Split-Thickness Skin Graft Donor Site Wound Healing Study
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PubMed Articles
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Simultaneous Very-Thick Split-Thickness and Split-Thickness Skin Grafting for Treating Burned Limbs.
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In vivo comparison of microcirculation and histomorphology of two different flap donor sites.
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The aim of this study was to determine if split-thickness skin grafts could be successfully used for closure of foot and ankle wounds in diabetic patients. The authors retrospectively reviewed the cha...
