DERM-SILK: Silicone Gel Pad (Keloid and Hypertrophic scars)

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Available from:

NEOMED PHARMACEUTICAL

Administration route:

TOPICAL

Therapeutic indications:

DERM-SILK : ideally dimensioned for medium to large scars from burns, road rash, or keloid and old and new hypertrophic scars from surgery or trauma. Clinically proven to reduce, flatten, fade and smooth scars -- both old and new Helps prevent the formation of new scars Each DERM-SILK contains: Dimethyl methyl hydrogen, methylvinyl silicone gel Organopolysiloxane For non-invasive management of old and new hypertrophic or keloid scars resulting from burns, general surgical procedures, injuries or trauma wounds. reduce, flatten, fade and smooth scars -- both old and new Helps prevent the formation of new scars. DERM-SILK is contraindicated in patients with known hypersensitivity to silicone or any of the listed ingredients.

Authorization status:

Premarket Notification

Summary of Product characteristics

DERM-SILK- ELASTOMER, SILICONE, FOR SCAR MANAGEMENT PATCH
NEOMED PHARMACEUTICAL
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DERM-SILK: SILICONE GEL PAD (KELOID AND HYPERTROPHIC SCARS)
DERM -SILK
(SILICONE GEL SHEETING)
RX ONLY
FOR EXTERNAL USE ONLY
NOT FOR OPHTHALMIC USE
DERM-SILK: ideally dimensioned for medium to large scars from burns,
road rash, or keloid and old
and new hypertrophic scars from surgery or trauma. Clinically proven
to reduce, flatten, fade and
smooth scars -- both old and new Helps prevent the formation of new
scars
Each DERM-SILK contains: Dimethyl methyl hydrogen, methylvinyl
silicone gel Organopolysiloxane
DERM-SILK - CLINICAL PHARMACOLOGY
The exact mechanism of silicone gel in improving the appearance of
scar tissue remains unknown.
However, numerous mechanisms have been suggested to explain the
efcacy of silicone gel, 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 inuence the alignment of collagen deposition.
INDICATIONS AND USES
For non-invasive management of old and new hypertrophic or keloid
scars resulting from burns, general
surgical procedures, injuries or trauma wounds. reduce, flatten, fade
and smooth scars -- both old and
new He