PERFORATED FOAM APPLICATION
Fig. 6
Fig. 7
Fig. 8
The perforated foam (Fig. 6) provided with the ABTHERA ADVANCE™ Open Abdomen Dressing is
intended to:
•
Transfer negative pressure from the Negative Pressure Therapy Unit to the Visceral Protective
Layer to promote active fluid removal.
•
Provide medial tension upon foam collapse to help maintain fascial domain.
1. Tear or cut perforated foam to needed size as shown above (Fig. 7). The foam should fit
directly over the Visceral Protective Layer and be in contact with wound edges. Do not allow
foam to contact intact skin. One or both pieces of the provided perforated foam can be used,
depending on the wound profile.
2. Gently place perforated foam into wound cavity over the Visceral Protective Layer (Fig. 8).
NOTE: Ensure foam-to-foam contact for even distribution of negative pressure.
NOTE: Always note the total number of pieces of foam used and document on the drape and in the
patient' s chart.
DRAPE APPLICATION
Fig. 9
Fig. 10
Fig. 11
Fig. 12
Fig. 13
1. Holding the drape, partially pull back one side of layer 1 to expose adhesive (Fig. 9). Be sure to
hold layer 1 flap back, to prevent re-adherence to drape.
2. Place the drape adhesive-side down to cover foam and intact skin, ensuring drape covers at
least an 8 - 10 cm border of intact periwound tissue (Fig. 10). Use any excess drape to seal
difficult areas, if needed.
NOTE: To avoid trauma to the periwound skin, do not pull or stretch the drape over the
foam dressing. Minimize wrinkles, as they may be a source of negative pressure leaks (refer to
PRECAUTIONS, Protect Periwound Skin section).
3. Remove remaining tab 1 backing material and pat around drape to ensure an occlusive seal.
4. Remove green-striped stabilization layer 2 (Fig. 11).
5. Remove perforated blue handling tabs from drape (Fig. 12).
NOTE: When using multiple pieces of drape, ensure that the edges of the drape overlap in order to
achieve a seal (Fig. 13).
SENSAT.R.A.C.™ PAD APPLICATION
Fig. 16
Fig. 14
Fig. 15
Fig. 17
NOTE: Do not cut off the pad or insert the tubing into the foam dressing. This may occlude the tubing
and cause the Negative Pressure Therapy Unit to alarm and could injure underlying viscera.
1. Choose pad application site. Give particular consideration to fluid flow and tubing position to
allow for optimal flow and avoid placement over bony protuberances or within creases in the
tissue.
2. Pinch drape and cut a 2.5 cm hole (not a slit) through the drape (Fig. 14). It is not necessary to
cut into the foam.
NOTE: Cut a hole rather than a slit, as a slit may self-seal during therapy.
3. Apply pad, which has a central disc and a surrounding outer adhesive skirt.
•
Gently remove both backing layers 1 and 2 to expose adhesive (Fig. 15).
•
Place pad opening in central disc directly over hole in drape (Fig.16).
•
Apply gentle pressure on the central disc and outer skirt to ensure complete adhesion of
the pad.
4. Pull back on blue tab to remove pad stabilization layer (Fig. 17). Dressing application is
complete.
V.A.C.® NEGATIVE PRESSURE THERAPY APPLICATION
Fig. 18
NOTE: Only for use with Negative Pressure Therapy provided by INFOV.A.C.™ and V.A.C.ULTA™ Negative
Pressure Therapy Units. Refer to the therapy unit user manual for complete instructions for use.
NOTE: SENSAT.R.A.C.™ Pad tubing is not compatible with hospital vacuum systems.
WARNING: Review all Negative Pressure Therapy System Safety Information before
initiating therapy.
1. Remove canister from packaging and insert into the therapy unit until it locks into place.
NOTE: Abdominal wounds often have copious drainage. Consider using the 1000 cc / mL canister.
Ensure an adequate supply of canisters is readily available.
CAUTION: Consider the size and the weight of the patient, patient condition, wound type,
monitoring capability and care setting when using the 1000 cc / ml canister.
NOTE: If the canister is not fully engaged, the therapy unit will alarm.
2. Connect SENSAT.R.A.C.™ Pad tubing to canister tubing and ensure clamp on each tube is open
(Fig. 18). Position clamps away from patient.
3. Turn on power to the therapy unit and select 125 mmHg, continuous mode therapy setting
for efficient fluid removal rates. Negative pressure therapy settings below 125 mmHg are not
recommended.
CAUTION: Do not use intermittent therapy / DYNAMIC PRESSURE CONTROL™ Therapy with the
ABTHERA ADVANCE™ Open Abdomen Dressing.
4. Initiate therapy. Assess dressing to ensure integrity of seal. The dressing should collapse and
have a wrinkled appearance. There should be no hissing sounds. If there is any evidence of non-
integrity, check drape and SENSAT.R.A.C.™ Pad seals, tubing connections, and canister insertion,
and ensure clamps are open. Secure excess tubing to prevent inadvertent tension on tubing,
which may disrupt the seal.
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 the Negative
Pressure Therapy Unit, the volume of exudate in the canister and tubing should be frequently
examined
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. (Refer to WARNINGS, Bleeding section).
ALARM RESOLUTIONS
All therapy unit alarms should be addressed in a timely manner. Refer to the therapy unit user
manual for complete information on alarm resolutions.
In case of a leak alarm, patch leak source with additional drape to ensure integrity of seal.
CAUTION: Due to the highly exudative nature of abdominal wounds, Negative Pressure Therapy should
be interrupted only for wound care and dressing change. Interruption of therapy can result in loss of seal
integrity.
DRESSING CHANGES
Dressing changes should occur every 24 to 72 hours, or more frequently based upon a continuing
evaluation of wound condition and patient presentation. Consider more frequent dressing changes
in the presence of infection or abdominal contamination.
Refer to Application Setting section under WARNINGS.
Whenever the dressing is changed, always replace all dressing components with components from
an unopened sterile package.
DRESSING REMOVAL
Remove and discard previous dressing per institution protocol. Completely inspect wound,
including paracolic gutters, to ensure all pieces of dressing components have been removed.
If intra-abdominal packing is present, 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.
WARNING: Refer to Dressing Removal section under WARNINGS.
EXPLANATION OF SYMBOLS USED
Do not use if package is
Manufacturer
damaged or open
Single use only
Date of Manufacture
Do not resterilize
Content information
n
Each
Consult instructions for use
CAUTION:
Federal (US) law restricts
this device to sale / rental by or on
Contains Phthalates
the order of a physician.
Catalog number
Method of sterilization -
Radiation
LOT
Lot number
Use by
Keep dry
Always count and record number of
foam pieces used in wound.
REFERENCE LIST
References available on request. Please contact KCI at 1-800-275-4524 (in the US).
Kaplan M. Managing the open abdomen. Ostomy Wound Management, 2004 Jan; 50(1A suppl); C2,
1-8
Kaplan M, Banwell P, Orgill DP, Ivatury RR, Demetriades D, Moore FA, Miller P, Nicholas J, Henry S,
Guidelines for the Management of the Open Abdomen. WOUNDS. 2005 Oct; 17(Suppl 1); S1S24
Garner GB, Ware DN, Cocanour CS, Duke JH, McKinley BA, Kozar RA, Moore FA. Vacuum-assisted
wound closure provides early fascial reapproximation in trauma patients with open abdomens. The
American Journal of Surgery, 2001 Dec; 182(6); 630-8
Barker DE, Kaufman HJ; Vacuum Pack Technique of Temporary Abdominal Closure; A 7-Year
Experience with 112 Patients. Presented at the 59th Annual Meeting of the American Association for
the Surgery of Trauma. September 16-18, 1999. Boston Mass.
Brock WB, Barker DE; Temporary Closure of Open Abdominal Wounds; The Vacuum Pack. Presented
at the 66th Annual Scientific Meeting of the Southeastern Congress, Lake Buena Vista, Florida.
February 6-10, 1994
Sherck J, Seiver A; Covering the "Open Abdomen"; A Better Technique. Presented as a Poster at
the 66th Annual Scientific Meeting and the Postgraduate Course Program. Southeastern Surgical
Congress. Atlanta, Georgia. January 31-February 4, 1998.
CONTACT INFORMATION
For questions regarding this product, maintenance, or additional information about KCI products
and services, please contact KCI or a KCI authorized representative, or:
In the US call 1-800-275-4524 or visit www.acelity.com or www.openabdomen.com.
KCI USA, Inc., 12930 IH 10 West, San Antonio, TX 78249
Outside the US visit www.kci-medical.com.
MANUFACTURER INFORMATION
Manufactured For:
KCI USA, Inc.
12930 IH 10 West
San Antonio, TX 78249 USA
1-800-275-4524
www.acelity.com
All trademarks designated herein are property of KCI Licensing, Inc., its affiliates, and / or licensors.
Copyright 2018 KCI Licensing, Inc. All rights reserved. 419020 Rev A 3/2018