Contraindications - COOK Medical OASIS Mode D'emploi

OASIS® EXTRACELLULAR MATRIX
DEVICE DESCRIPTION
OASIS® EXTRACELLULAR MATRIX (ECM) is a dried sheet of small
intestinal submucosa (SIS) used to manage partial-thickness
wounds (comprising only epidermal and/or dermal layers) and
full-thickness wounds (reaching subcutaneous tissue). Once
applied, the natural composition of SIS allows for the patient's
healing mechanisms to deposit cells and collagen during
cellular and extracellular matrix metabolism. Typically within
one week, the patient's tissues incorporate the SIS, resulting
in new, remodeled tissue.1-3 Results from a randomized
controlled study showed that the mean frequency of OASIS
reapplication was 6.4 ± 1.4 days and demonstrated clinical
efficacy with no adverse events at that frequency.3
INTENDED USE
OASIS ECM is intended for the management of partial and full-
thickness wounds. It is indicated to treat the following types of
chronic and acute wounds:
• Abrasions
• Burns (second-degree only)
• Chronic vascular ulcers
• Diabetic ulcers
• Donor sites
• Lacerations
• Pressure ulcers
• Post-surgical dermal wounds
• Skin tears
• Venous ulcers
This symbol means the following:
CAUTION: This product is intended for use by trained
medical professionals.
This symbol means the following: Magnetic Resonance
Safe
OASIS ECM is supplied sterile in peel-open packages and is
intended for one-time use.
COMPOSITION
OASIS ECM is derived using a process that retains the natural
composition of matrix molecules such as collagen (Types I,
III, IV, VI), glycosaminoglycans (hyaluronic acid, chondroitin
sulfate A and B, heparin, and heparan sulfate), glycoproteins
(fibronectin) and growth factors (FGF-2, TGF-β).

CONTRAINDICATIONS

OASIS ECM is derived from a porcine source and should not
be used in patients with known sensitivity to porcine material.
OASIS ECM is not indicated for use in third degree burns.
PRECAUTIONS
• Do not re-sterilize. Discard all open and unused portions
of the OASIS ECM.
4,5
3
ENGLISH