Product Description - KCI MANUAL DE UTILIZÓ Instrucciones De Uso

ABTHERA ADVANCE™
OPEN ABDOMEN DRESSING
INSTRUCTIONS FOR USE
Only for use with Negative Pressure Therapy provided by INFOV.A.C.™ or
V.A.C.ULTA™ Therapy Units

PRODUCT DESCRIPTION

The ABTHERA ADVANCE™ Open Abdomen Dressing, when used with Negative Pressure Therapy
provided by the INFOV.A.C.™ and V.A.C.ULTA™ Therapy Units provides an active temporary
abdominal closure system, designed to remove fluids from the abdominal cavity and draw wound
edges together, helping to achieve primary fascial closure while protecting abdominal contents
from external contaminates.
SAFETY INFORMATION
IMPORTANT: As with any prescription medical device, failure to consult a physician and carefully
read and follow all therapy unit and dressing instructions and safety information prior to each use
may lead to improper product performance and the potential for serious or fatal injury. Do not
adjust therapy unit settings or perform therapy application without directions from / or supervision
by the clinical caregiver.
All disposable components of the ABTHERA ADVANCE™ Open Abdomen Dressing are for single
use only. Re-use of disposable components may result in wound contamination, infection and / or
failure of the wound to heal.
INDICATIONS FOR USE
The ABTHERA ADVANCE™ Open Abdomen Dressing is indicated for temporary bridging of
abdominal wall openings where primary closure is not possible and / or repeat abdominal entries
are necessary. The intended use of this dressing is in open abdominal wounds with exposed viscera
including, but not limited to, abdominal compartment syndrome. The intended care setting is a
closely monitored area within the acute care hospital, such as the ICU. The abdominal dressing will
most often be applied in the operating theater.
CONTRAINDICATIONS
• Never place exposed foam material directly in contact with exposed bowel, organs, blood
vessels or nerves. Protect vital structures with the Visceral Protective Layer at all times during
therapy.
• Patients with open abdominal wounds containing non-enteric unexplored fistulas should not be
treated with the ABTHERA ADVANCE™ Open Abdomen Dressing.
Management of the open abdomen has been documented in case reports and consensus panel
literature. Please refer to the References List section of this document.
WARNINGS
Not for use with Instillation Therapy: Although it is accepted medical practice to flush
a contaminated open abdominal cavity with saline or other medical solutions, the ABTHERA
ADVANCE™ Open Abdomen Dressing was not designed for this purpose, and KCI has no studies to
support its safe and effective use with instillation therapy. Potential risks of instillation into the open
abdomen include:
•
Instillation of fluid in the abdomen without sufficient fluid recovery may lead to abdominal
compartment syndrome.
• Instillation of fluids in the abdomen that are untested for safety and efficacy with this application
could lead to severe hollow viscus and solid organ damage.
•
Instillation of unwarmed fluid in large quantities may lead to hypothermia.
Only Use the SENSAT.R.A.C.™ Pad: Substitution with any other tubing, alteration of the
SENSAT.R.A.C.™ Pad or breach of the prescribed SENSAT.R.A.C.™ Pad application for the purpose of
instilling fluids into the open abdomen is not recommended under any circumstance. This may
lead to loss of system efficacy or harm to the patient.
Bleeding: Patients with abdominal wounds must be closely monitored for bleeding as
these wounds may contain hidden blood vessels which may not be readily apparent. If
sudden or increased bleeding is observed in the dressing, tubing or canister, immediately
discontinue Negative Pressure Therapy, take appropriate measures to stop bleeding, and
contact the physician. Negative Pressure Therapy is not designed to prevent, minimize or
stop bleeding.
Hemostasis must be achieved prior to dressing placement.
The following conditions may increase the risk of potentially fatal bleeding.
•
Suturing and / or anastomoses
•
Trauma
•
Radiation
• Inadequate wound hemostasis
•
Non-sutured hemostatic agents (for example, bone wax, absorbable gelatin sponge or spray
wound sealant) applied in the abdomen may, if disrupted, increase the risk of bleeding. Protect
against dislodging such agents.
•
Infection in the abdominal wound may weaken visceral organs and associated vasculature,
which may increase susceptibility to bleeding.
•
Use of anticoagulants or platelet aggregation inhibitors.
• Bone fragments or sharp edges could puncture vessels or abdominal organs. Beware of possible
shifting in the relative position of tissues, vessels or organs within the abdominal wound that
might increase the possibility of contact with sharp edges.
Intra-abdominal Pressure Monitoring: Laparotomy with the placement of any temporary
abdominal closure does not eliminate the possibility of elevation in intra-abdominal pressure
(IAP). When using Negative Pressure Therapy, IAP monitoring (for clinical or diagnostic signs and
symptoms of elevated IAP) should continue as indicated by patient condition and in accordance
with institutional clinical practice or guidelines. If intra-abdominal hypertension (IAH) or abdominal
compartment syndrome (ACS) is observed or suspected, note intra-abdominal pressures and
turn off power to the Negative Pressure Therapy Unit, discontinuing negative pressure. After full
expansion of the perforated foam, obtain a new intra-abdominal pressure measurement. If IAH
/ ACS persists without negative pressure, discontinue the use of Negative Pressure Therapy and
address the underlying condition as medically indicated.
Use of Visceral Protective Layer: When using Negative Pressure Therapy, ensure that the Visceral
Protective Layer completely covers all exposed viscera and completely separates the viscera from
contact with the abdominal wall. Place the Visceral Protective Layer over the omentum or exposed
internal organs, and carefully tuck it between the abdominal wall and internal organs, making sure
the Visceral Protective Layer completely separates the abdominal wall from the internal organs.
Adhesions and Fistula Development: Formation of adhesions of the viscera to the abdominal
wall may reduce the likelihood of fascial reapproximation and increase the risk of fistula
development which is a common complication in patients with exposed viscera.
Infection: Infected abdominal wounds should be monitored closely and may require more
frequent dressing changes than non-infected wounds, dependent upon factors such as patient
condition, wound condition and treatment goals. Refer to dressing application instructions for
details regarding dressing change frequency.
Dressing Placement: Always use a dressing from a sterile package that has not been opened or
damaged. Do not force any dressing component into the wound, as this may damage underlying
tissue.
Dressing Removal: The dressing components are not bioabsorbable. Always remove all dressing
components from the abdomen at every dressing change.
Keep Negative Pressure On: Never leave the dressing in place without active negative pressure
for more than two hours. If negative pressure is off for more than two hours, change dressing as
shown in the dressing application instructions. Either apply a new dressing from an unopened
sterile package and restart negative pressure, or apply an alternative dressing.
Defibrillation: Remove adhesive drape from area of defibrillation to prevent inhibition of electrical
energy transmission.
Acrylic Adhesive: The drape has an acrylic adhesive coating, which may present a risk of adverse
reaction in patients who are allergic or hypersensitive to acrylic adhesives. If a patient has a known
allergy or hypersensitivity to such adhesives, do not use the dressing. If any signs of allergic
reaction or hypersensitivity develop, such as redness, swelling, rash, urticaria or significant pruritus,
discontinue use and ensure appropriate emergency medical treatment. If bronchospasm or more
serious signs of allergic reaction appear, remove dressing and ensure appropriate emergency
medical intervention as indicated.
Magnetic Resonance Imaging (MRI) – Therapy Unit: The Negative Pressure Therapy Unit is MR
unsafe. Do not take the device into the MR environment.
Magnetic Resonance Imaging (MRI) – ABTHERA ADVANCE™ Open Abdomen Dressing:
The dressing can remain on the patient with minimal risk in an MR environment, assuming that
use of Negative Pressure Therapy is not interrupted for more than two hours; please refer to Keep
Negative Pressure On section.
Hyperbaric Oxygen Therapy (HBO): Do not take the negative pressure therapy unit into
a hyperbaric oxygen chamber. The negative pressure therapy unit is not designed for this
environment, and should be considered a fire hazard. After disconnecting the negative pressure
therapy unit, either (i) replace the dressing with another HBO compatible material during the
hyperbaric treatment, or (ii) cover the unclamped end of the SENSAT.R.A.C.™ Pad Tubing with dry
gauze. For HBO therapy, the tubing must not be clamped. Never leave a dressing in place without
active negative pressure for more than two hours (refer to Keep Negative Pressure On section).
Application Setting: Dressing applications and changes should be performed under strict sterile
conditions in the operating theater. If dressing change is performed outside the operating theater, it
must be performed in an environment equipped to address the onset of critical complications (refer
to WARNINGS section) and where strict aseptic technique can be utilized.
PRECAUTIONS
Standard Precautions: To reduce the risk of transmission of bloodborne pathogens, apply
standard precautions for infection control with all patients, per institutional protocol, regardless
of their diagnosis or presumed infection status. In addition to gloves, use gown and goggles if
exposure to body fluids is likely.
Intra-abdominal Packing: When using intra-abdominal packing with Negative Pressure Therapy,
packing material may be drier than anticipated. Evaluate packing material prior to removal and
rehydrate if necessary to prevent adherence or damage to adjacent structures.
Monitor Fluid Output: The dressing is designed to efficiently remove fluid from the abdominal
compartment and to evenly distribute negative pressure. When treating patients with Negative
Pressure Therapy, the volume of exudate in the canister and tubing should be frequently examined.
Patient Size and Weight: The size and weight of the patient should be considered when
prescribing Negative Pressure Therapy. Initial lower negative pressure should be considered for
certain small or elderly patients who are at risk of fluid depletion or dehydration. Monitor fluid
output including the volume of exudate in both the tubing and canister. This therapy has the
potential to remove and collect large volumes of fluid. Tubing volume = approximately 25 mL from
SENSAT.R.A.C.™ Pad to canister.
Spinal Cord Injury: In the event a patient experiences autonomic dysreflexia (sudden changes
in blood pressure or heart rate in response to stimulation of the sympathetic nervous system),
discontinue Negative Pressure Therapy to help minimize sensory stimulation.
Bradycardia: To minimize the risk of bradycardia, the dressing must not be placed in proximity to
the vagus nerve.
Enteric Fistula or Leak: When treating an open abdomen where enteric fistulas are present,
clinicians should consider the potential for abdominal contamination if effluent is not appropriately
isolated or managed.
Protect Periwound Skin: Consider use of a skin preparation product to protect periwound skin.
Do not allow foam to overlap onto intact skin. Protect fragile / friable periwound skin with additional
drape, hydrocolloid or other transparent film.
•
Multiple layers of the drape may decrease the moisture vapor transmission rate, which may
increase the risk of maceration.
• If any signs of irritation or sensitivity to the drape, foam or SENSAT.R.A.C.™ Pad tubing appear,
discontinue use and consult a physician.
•
To avoid trauma to the periwound skin, do not pull or stretch the drape over the foam dressing
during drape application.
If there are any questions regarding the proper placement or usage of the ABTHERA ADVANCE™
Open Abdomen Dressing, please contact your local KCI clinical representative.
DRESSING APPLICATION
ABTHERA ADVANCE™ OPEN ABDOMEN DRESSING COMPONENTS
Perforated
Foam (2)
SENSAT.R.A.C.™
Pad (1)
Visceral Protective
Layer (1)
WOUND PREPARATION
WARNING: Review all ABTHERA ADVANCE™ Open Abdomen Dressing Safety Information
before beginning wound preparation. Ensure adequate hemostasis has been achieved
prior to dressing placement (refer to Bleeding section under WARNINGS).
1. Sharp edges or bone fragments must be eliminated from wound area or covered (refer to
Bleeding section under WARNINGS).
2. Irrigate abdominal wound and cleanse periwound skin as indicated.
3. Clean and dry periwound tissue; consider use of a skin preparation product to protect
periwound skin. Do not allow foam to overlap onto intact skin. Protect fragile / friable
periwound skin with additional drape, hydrocolloid or other transparent film.
VISCERAL PROTECTIVE LAYER APPLICATION
The Visceral Protective Layer is fenestrated to allow for active fluid removal when negative pressure
is applied and is designed to allow application of this layer directly over omentum or exposed
internal organs.
WARNING: The foam in the Visceral Protective Layer is encapsulated for patient safety.
Protect vital structures with Visceral Protective Layer at all times during therapy. Never
place exposed foam material directly in contact with exposed bowel, organs, blood
vessels or nerves.
Fig. 1 Fig. 2
1. Remove contents from inner pouch and unfold the Visceral Protective Layer in a sterile field.
Either side of the Visceral Protective Layer may be placed on the omentum or viscera.
2. Gently place Visceral Protective Layer over the open abdominal cavity (Fig. 1).
3. Determine the orientation of the dressing for the specific application. If Visceral Protective
Layer will be placed around tubes, drains or the falciform ligament, cut only between the foam
extensions (Fig. 2). Do not cut near or through foam extensions. Orient the Visceral Protective
Layer accordingly before cutting.
4. Size the Visceral Protective Layer by folding or cutting as described in the following sections.
Folding Visceral Protective Layer to Size
Fig. 3
1. Hold dressing by the edge and slightly lift. Slowly lower dressing into the paracolic gutter, using
the other hand to gently and evenly work the dressing down (Fig. 3). Fold any excess Visceral
Protective Layer up and over onto itself.
2. Continue placing Visceral Protective Layer between abdominal wall and internal organs (Fig. 4)
throughout the abdominal compartment. The goal is to ensure full coverage of all viscera.
Cutting Visceral Protective Layer to Size
Drape (4)
A
Fig. 5
1. Cut Visceral Protective Layer away from wound, through center of large foam squares using
sterile scissors (Fig 5A). Do not cut through narrow connecting tabs between the large foam
squares.
2. Pinch the remaining half of the foam square and its connecting tab and pull. The foam and tab
will separate at the next square (Fig. 5B). This will ensure that edges of Visceral Protective Layer
cover exposed foam edge (Fig. 5C) and foam cannot contact organs (see WARNING above).
3. Document number of foam extensions removed and that each piece has been properly
disposed of away from wound cavity.
CAUTION: Do not tear the foam over the wound, as fragments may fall into the wound. Rub or trim
foam away from wound, removing any fragments to ensure loose particles will not fall into or be left
in the wound upon dressing removal.
Fig. 4
B C