PROSILK MEDICAL GRADE SILICONE SCAR PAD-

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Available from:

NATIONAL BIO GREEN SCIENCES LIMITED LIABILITY COMPANY

Therapeutic indications:

For use in the management of closed hyperproliferative (hypertrophic or keloid) scars. ProSilk Medical Grade Silicone Scar Pad is contraindicated in patients with known hypersensitivity to silicone or any of the listed ingredients.

Authorization status:

Exempt device

Summary of Product characteristics

PROSILK MEDICAL GRADE SILICONE SCAR PAD- ELASTOMER, SILICONE, FOR SCAR
MANAGEMENT
NATIONAL BIO GREEN SCIENCES LIMITED LIABILITY COMPANY
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PROSILK PAD
PROSILK MEDICAL GRADE SILICONE SCAR PAD
NATIONAL BIO GREEN SCIENCES LIMITED LIABILITY COMPANY
RX ONLY
FOR EXTERNAL USE ONLY
NOT FOR OPHTHALMIC USE
NBGS PROSILK MEDICAL GRADE SILICONE SCAR PAD DESCRIPTION
PROSILK MEDICAL GRADE SILICONE SCAR PAD is intended for use in the
management of closed
hyperproliferative scars, both old and new hypertrophic or keloid
scars resulting from burns, surgical
procedures or trauma wounds.
Each PAD contains: Medical Grade Silicone
CLINICAL PHARMACOLOGY
The exact mechanism of action in improving the appearance of scar
tissue from using silicone remains
unknown. However, various suggestions have been made to explain the
efficacy of silicone sheets,
including hydration, pressure, temperature, oxygen transmission and
silicone absorption. There is some
evidence that the treatment affects the stratum corneum and, by
reducing evaporation, restores better
homeostasis in the tissue. In keloid and hypertrophic scarring, the
stratum corneum allows more
evaporation of water from the underlying tissue than occurs in normal
skin. Silicone pads may prevent
this, keeping the stratum corneum in optimal hydration and protecting
the skin from environmental
hazards, both of which can reduce abnormal scarring. The gel may also
affect the stratum corneum by
inhibiting mast cell activity, diminishing edema, vasodilatation and
excessive extracellular matrix
formation but the simple changes in temperature, pressure, oxygen
tension and hydration produced by
wound coverage probably constitute the main mechanism of action.
Another hypothesis is that the effect
of static electricity on silicone may influence the alignment of
collagen deposition.
INDICATIONS AND USES
For use in the management of closed hyperproliferative (hypertrophic
or keloid) scars.
CONTRAINDICATIONS
PROSILK MEDICAL GRADE SILICONE SCAR PAD is contraindicated in patients
with known hyper