KERAMATRIX dressing wound drug

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AMINO ACIDS, HAIR KERATIN (UNII: G46579QK1M) (AMINO ACIDS, HAIR KERATIN - UNII:G46579QK1M)

Available from:

Keraplast Technologies, LLC

INN (International Name):

AMINO ACIDS, HAIR KERATIN

Composition:

AMINO ACIDS, HAIR KERATIN 100 mg

Authorization status:

Exempt device

Summary of Product characteristics

KERAMATRIX- DRESSING, WOUND, DRUG
KERAPLAST TECHNOLOGIES, LLC
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KERAMATRIX
_WOUND MATRIX_
STERILE
R
Rx Prescription Only
Single Use
CAUTION: Federal (U.S.A.) law restricts this device to sale by or on
the order of a physician(or
properly licensed Healthcare practitioner).
INDICATIONS FOR USE
Acute Surgical Wounds, donor sites/grafts, podiatric wounds, wound
dehiscence, Diabetic ulcers,
traumatic wounds, First & Second Degree Burns, chronic vascular
ulcers, venous ulcers, Pressure
ulcers, partial & full thickness wounds.
SUGGESTED DIRECTIONS FOR USE OF KERAMATRIX
_NOTE: ALWAYS HANDLE USING ASEPTIC TECHNIQUE_
_WOUND BED PREPARATION &_
_APPLICATION_
_DRESSING CHANGES AND_
_REAPPLICATIONS_
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®
Prepare wound area using standard
debridement methods to ensure the
wound is free of debris and devitalized
tissue. The wound may be surgically
debrided to ensure the wound edges
contain viable tissue.
Cut the dry keramatrix
sheet into a
piece slightly larger than the outline of
the wound area. If the wound is larger
than a single sheet then multiple sheets
may be used,overlapping edges as
necessary.
®
For a wound with a low-level of exudate
hydrate the matrix by soaking it in sterile
saline solution for 2 minutes prior to
application.
Place the edge of the sheet in contact
with intact tissue and smooth the
dressing so that it contacts the
underlying wound bed. If multiple sheets
are used, overlap adjoining sheets to
provide coverage of the entire wound.
Secure with Physicians preferred
Change keramatrix
dressing as
necessary every 4 to 5 days days or as
determined by the healthcare provider.
Do not remove existing Gel or Matrix
areas. The Matrix will carmelize into a
Gel and have a off white light brown
color.
®
Once cleansed with Sterile Saline
solution keramatrix may be reapplied.
Ensure that there are no bleeding areas
and that the wound edges are clean.
For a wound with a medium to high
level of exudate, place the edge of the
sheet in contact with intact tissue and
smooth the dressing so t