Contraindications - Integra Flowable Wound Matrix Gebrauchsanleitung

Description
Integra® Flowable Wound Matrix is an advanced wound care device comprised of a granulated
form of the Integra Dermal Regeneration Template-Single Layer. The product is manufactured
from cross-linked bovine tendon collagen and glycosaminoglycan. The granulated collagen-
glycosaminoglycan is hydrated with saline and applied in difficult to access wound sites and
tunneled wounds. It provides a scaffold for cellular invasion and capillary growth.
Integra Flowable Wound Matrix is supplied sterile, in single use kits containing one syringe with
granular collagen, one empty sterile syringe, one luer lock connector, and one flexible injector.
Indications
Integra Flowable Wound Matrix is indicated for the treatment of tunneling and/or undermined
wounds including surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery,
podiatric, wound dehiscence) and diabetic ulcers of both partial and full-thickness varieties. The
device is intended for one-time use.

Contraindications

• This device should not be used in patients with known sensitivity to bovine collagen or
chondroitin sulfate derived from shark cartilage.
• The device is not indicated for use in third degree burns.
Precautions
• Do not resterilize. Discard all opened and unused portions of Integra Flowable Wound Matrix.
• Device is sterile if the package is unopened and undamaged. Do not use if the package seal
is broken.
• Discard device if mishandling has caused possible damage or contamination.
• Integra Flowable Wound Matrix should not be applied until excessive exudate, bleeding, acute
swelling and infection are controlled.
• Debridement or excision must be done thoroughly to remove any remaining necrotic tissue that
may cause infection.
• The following complications are possible with the use of wound management products:
infection, chronic inflammation (initial application of wound dressings may be associated with
transient, mild, localized inflammation), allergic reaction, excessive redness, pain, or swelling.
If any of these conditions occur, the device should be removed.
3