INTENDED USE:
OASIS is indicated for the management of wounds including:
• Partial and full-thickness wounds
• Pressure ulcers
• Venous ulcers
• Chronic vascular ulcers
• Diabetic ulcers
• Trauma wounds (abrasions, lacerations, second-degree burns, skin tears)
• Drainage wounds
• Surgical wounds (donor sites/grafts, post-Mohs surgery,
post-laser surgery,
podiatric, wound dehiscence)
OASIS is supplied sterile in peel-open packages and is
intended for one-time use.
CAUTION: Federal (U.S.A.) law restricts this device to sale by
or on the order of a physician (or properly licensed practitioner).
CONTRAINDICATIONS:
This device is derived from a porcine
source and should not be used in patients with known
sensitivity to porcine material. This device is not indicated for
use in third degree burns.
PRECAUTIONS:
• Do not re-sterilize. Discard all open and unused portions of OASIS.
• Device is sterile if the package is dry, unopened and undamaged.
Do not use if the package seal is broken.
• The device must be used prior to the expiration date.
• Discard device if mishandling has caused possible damage or contamination.
• OASIS should not be applied until excessive exudate, bleeding, acute
swelling, and infection is controlled.
POTENTIAL COMPLICATIONS:
The following complications
are possible. If any of these conditions occur, the device
should be removed.
• Infection
• Chronic inflammation (Initial application of wound dressings may
be associated with transient, mild, localized inflammation.)
• Allergic reaction
• Excessive redness, pain, swelling, or blistering
STORAGE:
This device should be stored in a clean, dry location at room temperature.
STERILIZATION:
This device has been sterilized with ethylene oxide.
SUGGESTED INSTRUCTIONS FOR USING OASIS
These recommendations are designed to serve only as a
general guideline. They are not intended to supersede
institutional protocols or professional clinical judgment
concerning patient care.
NOTE: Always handle OASIS using aseptic technique.
- Prepare wound area using standard methods to ensure
wound is free of debris and necrotic tissue. An initial surgical
debridement of the wound may be necessary to ensure the
wound edges contain viable tissue.
- To apply, cut the dry sheet to a size slightly larger than
the
outline of the wound area. If the wound is larger than a single
sheet, then multiple sheets may be used. Overlap adjoining
sheets to provide coverage of the entire wound. For ease of
handling, apply OASIS by placing it in a dry state over the
wound and rehydrating the sheet using sterile saline or other
isotonic solution. Alternatively, rehydrate the sheet by placing
it in a bowl of sterile saline or other isotonic solution for at
least
one (1) minute prior to use.
- Place the edge of the sheet in contact with the intact tissue.
Smooth OASIS into place to ensure the sheet is in contact with
the underlying wound bed.
NOTE: If excess exudate collects under the sheet, small
openings can be cut in the sheet to allow the exudate to
drain.
IMPORTANT: After application, use an appropriate, nonadherent,
secondary dressing to maintain a moist wound
environment. The optimum secondary dressing is determined
by wound location, size, depth, and user preference. Change
the secondary dressing as needed to maintain a moist, clean
wound area. Frequency of secondary dressing change will be
dependent upon volume of exudate produced and type of
dressing used. As healing occurs, sections of OASIS may
gradually peel and may be removed during dressing changes.
Do not forcibly remove sections of OASIS that may adhere to
the wound. Alternatively, OASIS may form a caramel-colored
gel, which can be rinsed away with gentle irrigation. On
inspection, if OASIS is no longer covering the wound, place an
additional piece of OASIS over the wound.
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