Biomedical Engineering Reference
In-Depth Information
Preclinical data
Animal wound models: the choice of an animal model should be based upon valid
scientific evidence. A literature search should be conducted and an appropriate
animal model chosen that can address the desired treatment outcome. For example,
contraction and re-epithelialization can be evaluated on a full-thickness excisional
wound in a pig model for burns or chronic wounds. Multiple animal model studies
may be needed to support the use in human clinical trials.
Study population in clinical trials for biomaterials for skin loss
In clinical trials for biomaterials for skin loss, various factors must be taken into
consideration. The patient population must be appropriate for the indication for use
for the type of wounds/skin loss. The patient population must also be adequate to
detect a treatment effect. It is important to include the patient population, espe-
cially the age range for which the product will be indicated for use. It will be
important to establish the risk analysis for the product to determine if the product
can be safely evaluated in high risk patient groups, especially pediatric or pregnant
women.
In burn patients, the depth, surface area, location of the burn wound, percent
body surface area, type of burn (thermal, electrical, chemical), demographic
information (age, gender), concomitant injuries, especially inhalation injuries as
well as trauma scores of the overall severity of the illness should be included such
as the trauma - injury severity score (TRISS)
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and the acute physiology and
chronic health evaluation (APACHE) Score.
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Chronic cutaneous ulcers
The major categories of chronic cutaneous ulcers are diabetic ulcers, venous stasis
ulcers and pressure ulcers. These types of chronic ulcers have very different
underlying medical etiologies and treatment regimes. Usually products for treat-
ment of these ulcers must be conducted in separate clinical trials specific to the
ulcer type.
Standard of care
Standard of care refers to accepted wound care procedures that will be used in the
clinical trial. Most burn centers and wound care centers have standard treatment
protocols. These standard protocols may vary between treatment centers. It is
important for the purposes of the clinical trial that the standard of care and
treatment protocols are standardized between investigators and investigational
site.
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Standard of care for chronic cutaneous ulcers includes the following:
