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Temporary Abdominal Closure

POSITIVE RESULTS
THE RIGHT TEMPORARY ABDOMINAL CLOSURE (TAC)
METHOD MAY HELP IMPROVE PATIENT OUTCOMES.

The Challenge
Leaving the abdomen open, during the management of complex abdominal problems,
has become common practice. A prolonged open abdomen presents challenges such as:
•  Fluid loss
•  Infection
•  Loss of abdominal domain
•  Organ dysfunction and death.1

Clinical research has shown removing potentially detrimental peritoneal fluid and
achieving primary fascial closure are important goals when managing patients who
require an open abdomen for the treatment of critical illness.2

The method of temporary abdominal closure chosen may play an important role in
patient outcomes.1,3,4
The Solution
ABTHERA™ Open Abdomen Negative Pressure Therapy (ABTHERA™ Therapy) is designed
to actively manage the open abdomen by:
•  Removing fluid and helping reduce edema
•  Providing medial tension, which helps minimize fascial retraction and loss of domain5
• Helping protect abdominal contents from external environment
• Providing separation between abdominal wall and viscera, protecting abdominal contents
• Allowing rapid access for re-entry without requiring sutures for placement
• Providing a moist environment

Direction of fluid

Direction of medial tension


ABTHERA™ Therapy has been shown in clinical studies
ONE STUDY COMPARED ABTHERA™ THERAPY WITH THE
BARKER’S VACUUM PACKING TECHNIQUE.
In a twenty-center observational study comparing ABTHERA™ Therapy to Barker’s vacuum-packing
technique (BVPT) in trauma and surgical patients, ABTHERA™ OA NPT was associated with a
significantly improved 30-day primary fascial closure rate, and a 30-day all cause mortality rate
(p=0.03 and 0.01 respectively).1

Study design
•O
 bservational, open-label study performed to evaluate two • Patients were both trauma and surgical patients who required
TAC techniques: ABTHERA™ Therapy and the Barker’s vacuum- TAC following a damage control laparotomy or treatment of
packing technique. either Intra-abdominal hypertension or severe sepsis.
•2
 80 patients enrolled from 20 sites in the U.S. • 168 patients who received at least 48 hours of consistent TAC
therapy (111 ABTHERA™ Therapy, 57 BVPT) were evaluated.
• Both groups showed similar patient severity assessment
scores (SOFA, APACHE, ISS).

Key findings

30-day primary fascial closure 30-day all-cause mortality


p=0.03 p=0.01
100% 100%
69%
77 of 111 patients
51%
29 of 57 patients
30%
17 of 57 patients
14%
15 of 111 patients

0% 0%
ABTHERA™ Therapy Barker’s vacuum-packing ABTHERA™ Therapy Barker’s vacuum-packing
technique technique

Other findings
• The median time to primary fascial closure was 9 days for • Patients treated with ABTHERA™ Therapy were 3.2 times
patients treated with ABTHERA™ Therapy and 12 days for more likely to survive up to 30 days than patients treated with
those treated with Barker’s vacuum-packing technique (p=0.12). Barker’s vacuum-packing technique (p=0.02).
 atients treated with ABTHERA™ Therapy were 2.0 times more
•P
likely to achieve 30-day primary fascial closure than patients
treated with Barker’s vacuum-packing technique (p=0.06).
to be associated with positive clinical outcomes.
A STUDY EVALUATED ABTHERA™ THERAPY AND THE
AVOIDED COSTS FOR VENTRAL HERNIA REPAIRS
In this study, 33 of 37 (89%) of open abdomen patients achieved midline fascial closure using
ABTHERA™ Therapy.6

Study Design
• Comparative retrospective review • Univariate analysis identified only three statistically
• 37 open abdomen patients who had temporary abdominal significant differences between the study populations:
closure with the ABTHERA™ Open Abdomen Negative • BMI was higher in the ABTHERA™ Therapy group (32 kg/
Pressure Therapy System from 2010 to 2011 m2 vs 27 kg/m2) p<0.05
• 37 open abdomen patients who were managed with the • Mean age was higher in the ABTHERA™ Therapy group (55
Barker’s technique from 2009 to 2010 years vs 47 years) p<0.05

• The 37 patients managed with the Barker’s technique were


the most recent patients treated before the facility
transitioned to using the ABTHERA™ System

100% 89% Midline fascial closure was 89%


33 of 37 patients for ABTHERA™ Therapy and 59%
90% for BVPT (p<0.05)
80%
70% 59%
% Closed

22 of 37 patients
60%
50%
40%
30%
20%
10%
0
ABTHERA™ Therapy Barker’s vacuum packing technique

According to the authors


• Failure to achieve midline fascial closure leads to large ventral hernias needing subsequent repair
• The cost of a ventral hernia repair may be calculated at $16,000. Reference: HCUP (October 2012) data were used to calculate
the cost savings associated with the cost avoidance of ventral hernia repairs
• The difference in closure rates between the techniques may have prevented an estimated 11 ventral hernia repairs, which may
have resulted in an overall cost savings of $176,000
IMPROVED FLUID REMOVAL IN BENCH TESTING

During in vitro testing, ABTHERA™ Therapy was shown to provide better negative pressure
distribution and fluid removal than other TAC techniques.7
71

2
12
15

12

2
15
73

ABTHERA™ Therapy has been shown to provide rapid fluid removal through enhanced pressure distribution.*
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43
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ABTHERA™ Therapy V.A.C.® Abdominal Dressing System Barker’s vacuum-packing technique

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9
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43
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Red boxes with number represent location of pressure sensors and measured mmHg.

ABTHERA™ Therapy and V.A.C.® Abdominal Dressing System demonstrated significantly higher negative pressure
distribution (p<0.05) than Barker’s vacuum-packing technique during in vitro testing.

1.000 93ml/min 61ml/min 34ml/min


ABTHERA™ System V.A.C. ® Abdominal Barker’s vacuum-packing
0.900 Dressing

0.800

0.700
Volume (Liters)

0.600

0.500
ABTHERA™ System (avg)
0.400 V.A.C. ® Abdominal Dressing (avg)
Barker’s vacuum-packing (avg)
0.300
ABTHERA™ System peak flow
0.200
V.A.C. ® Abdominal Dressing peak flow
0.100 Barker’s vacuum-packing peak flow

0.000
0.00 5.00 10.00 15.00 20.00 25.00 30.00
Time (minutes)

ABTHERA™ Therapy has been shown to provide rapid and complete fluid removal through enhanced
pressure distribution.*
*In vitro test model designed to simulate OA physical condition – Constant -125mmHg negative pressure applied under dynamic conditions.
KEY FEATURES

ABTHERA™ Therapy is provided via the ABTHERA™ Therapy Unit or an approved KCI V.A.C.®
Therapy Unit*

• Provides continuous negative pressure to remove high-volume exudate


• Designed for simplicity, ease-of-use and rapid application

ABTHERA™ Drape
Provides a closed system to help isolate and protect
abdominal contents from external environment

ABTHERA™ Perforated Foam


Negative pressure delivered through the
foam provides medial tension, which helps
minimize fascial retraction and loss of
domain

ABTHERA™ Visceral
Protective Layer
• Enhances fluid removal from
paracolic gutters
• Allows rapid access for re-entry
• No sutures required for placement, mini-
mizing fascial damage
• Provides separation between
abdominal wall and viscera,
protecting abdominal contents

*Please see Instructions for Use or sterile pouch label provided with
the ABTHERA™ SENSAT.R.A.C.™ Open Abdomen Dressing.
ORDERING INFORMATION

Quantity Item number

ABTHERA™ Therapy Unit 1 therapy unit 370500

ABTHERA™ Canister 20 per case 370620

ABTHERA™ Open Abdomen Tubing Set 5 per case 370642

ABTHERA™ Open Abdomen Dressing


5 per case 370605
(includes Visceral Protective Layer, Perforated Foam, Drape and Tubing Set)

ABTHERA™ SENSAT.R.A.C.™ Open Abdomen Dressing* 5 per case M8275026/5


(includes Visceral Protective Layer, Perforated Foam, Drape and SENSAT.R.A.C.™ Tubing Set)

*ABTHERA™ Therapy is provided via KCI-approved V.A.C.® Therapy Units; please see Instructions for Use or sterile pouch label provided with the ABTHERA™
SENSAT.R.A.C.™ Open Abdomen Dressing.

References
1. Cheatham ML, Demetriades D, Fabian TC, et al. Prospective Study Examining Clinical Outcomes 5. M  iller PR, Meredith JW, Johnson JC, Chang MC. Prospective evaluation of vacuum-assisted
Associated with a Negative Pressure Wound Therapy System and Barker’s Vacuum Packing fascial closure after open abdomen: planned ventral hernia rate is substantially reduced. Annals
Technique. World J Surg. 2013 Sept;37(9):2018-2030. of Surgery. 2004 May;239(5):608-614.
2. Cheatham ML, Safcsak K. Is the evolving management of intra-abdominal hypertension and 6. Frazee RC, Abernathy SW, Jupiter DC, et al. Are Commercial Negative Pressure Systems Worth
abdominal compartment syndrome improving survival? Crit Care Med 2010;38:402-407. the Cost in Open Abdomen Management? J Am Coll Surg. 2013 April;216(4):730-3.
3. Kaplan M, Banwell P, Orgill DP, et al. Guidelines for the Management of the Open Abdomen. 7. S ammons A, Delgado A and Cheatham M. In vitro pressure manifolding distribution evaluation
Wounds. 2005 Oct;17(Suppl 1):S1 S24. of ABTHERA™ Active Abdominal Therapy, V.A.C.® Abdominal Dressing System, and the Barker’s
4. Cheatham ML, et al. Abdominal perfusion pressure; a superior parameter in the assessment of Vacuum Packing Technique, conducted under dynamic conditions. Presented at the Clinical
intra-abdominal hypertension. Journal of Trauma. 2000 Oct:49:621-626. Symposium on Advances in Skin and Wound Care, San Antonio, TX, October 22-25, 2009.

Contact KCI today – visit ABTHERA.com or call 800-275-4524


NOTE: Specific indications, contraindications, warnings, precautions and safety information exist for KCI products and therapies.
Please consult a physician and product instructions for use prior to application. Rx only.

©2016 KCI Licensing, Inc. All Rights Reserved. All trademarks designated herein are proprietary to KCI Licensing, Inc, its affiliates and
licensors. DSL#16-0144.US • LIT#29-A-218 • (Rev. 5/16)

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