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Autograft is a procedure that uses skin from other parts of the body to treat bad burns.
This procedure is very painful.
StrataGraft is an experimental tissue to use instead of the person's own skin.
- The sponsor has already been running clinical trials
- The product seems to be effective and safe enough to be used
- Soon the sponsor will be applying for approval from FDA
The sponsor submitted a treatment protocol to FDA for experienced doctors to keep using StrataGraft before it is marketed (expanded access).
The main purpose of the study is to allow patients to keep receiving StrataGraft prior to approval. The primary outcome measure will be the number of participants with adverse events.
The primary purpose of this trial is to provide expanded access to StrataGraft for thermally induced deep partial-thickness burns that contain intact dermal elements and for which surgical excision and autograft are clinically indicated.
Deep Partial-thickness Burn
StrataGraft skin tissue
University of South Alabama Medical Center
Temporarily not available
Stratatech, a Mallinckrodt Company
Published on BioPortfolio: 2019-10-15T11:10:35-0400
The proposed study is designed as a phase Ib open-label, dose-escalation, multicenter study evaluating the safety, tolerability, and efficacy of StrataGraft skin tissue in promoting the he...
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The proposed registration study is designed as a phase III open-label, controlled, randomized, multicenter study evaluating the efficacy and safety of StrataGraft skin tissue in promoting ...
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Layers of connective tissue of variable thickness. The superficial fascia is found immediately below the skin; the deep fascia invests MUSCLES, nerves, and other organs.
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)
Specialized hospital facilities which provide intensive care for burn patients.
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)
An acute, diffuse, and suppurative inflammation of loose connective tissue, particularly the deep subcutaneous tissues, and sometimes muscle, which is most commonly seen as a result of infection of a wound, ulcer, or other skin lesions.
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Acne Dermatology Eczema Psoriasis Wound Care Dermatology is the medical specialty concerned with the diagnosis and treatment of skin disorders (Oxford Medical Dictionary). As well as studying how the skin works, dermatology covers...
Clinical trials are a set of procedures in medical research conducted to allow safety (or more specifically, information about adverse drug reactions and adverse effects of other treatments) and efficacy data to be collected for health interventions (e.g...