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Benefits of VAC Therapy



Benefits of VAC Therapy:Overview



Executive Summary

• Negative Pressure Wound Therapy, V.A.C. Therapy has beenselected as the treatment of choice for more than 3,000,000people worldwide

• Recent studies have reported on the beneficial use ofNPWT/ROCF in temporizing combat wounds in preparation fordelayed primary closure. Adjunctive use of the therapy hasbeen shown to decrease time to closure, reduce amputations,reduce infection, and decrease labor required for dressingchanges

• Literature shows VAC Therapy may provide savings in traumawounds of $31,842 (for Abdominal Compartment Syndrome

patients) & savings of $33,040 (Limb Salvage)• This can account for an overall savings of $1.2M just for Limb

Salvage wounds



V.A.C. Therapy System

Overview

• KCI's proprietary V.A.C.® Therapy System has revolutionized the wayin which caregivers treat the most serious, complex wounds. V.A.C.Therapy utilizes an open-cell polymer foam dressing that is conformedto the wound bed. When sealed and placed under negative (vacuum)pressure, the system creates a unique wound healing environmentthat has been shown to promote the wound healing process, reduceedema, prepare the wound bed for closure, promote the formation of

granulation tissue and remove infectious materials.

History

• In 1996, KCI introduced this innovative approach to the treatment ofserious, complex wounds through the use of sub-atmospheric ornegative pressure. Known today as “negative pressure wound

therapy” (NPWT), KCI’s proprietary Vacuum Assisted Closure®

, orV.A.C.® Therapy System has revolutionized the advanced wound caremarket and remains the most clinically proven alternative for thetreatment of complex, hard-to-heal wounds.

http://www.kci1.com/KCI1/vactherapysystemfactsheet





V.A.C. Therapy

• Since its introduction, V.A.C.® Therapy has changed the way woundsare healed. With more published clinical evidence than any other formof Negative Pressure Wound Therapy, V.A.C. Therapy has been

selected as the treatment of choice for more than 3,000,000 peopleworldwide.

• V.A.C. Therapy promotes wound healing through Negative PressureWound Therapy (NPWT). By delivering negative pressure (a vacuum)at the wound site through a patented dressing, this helps draw wound

edges together, remove infectious materials and actively promotegranulation at the cellular level.

http://www.kci1.com/cs/Satellite?c=Page&childpagename=KCI1%2FKCILayout&cid=1229538260417&p=1229538260417&packedargs=locale%3Den_

US&pagename=KCI1Wrapper

http://www.kci1.com/cs/Satellite?c=Page&childpagename=KCI1/KCILayout&cid=1229538260417&p=1229538260417&packedargs=locale=en_US&pagename=KCI1Wrapper







V.A.C. Therapy Clinical Data

One of the most extensive bodies of evidence in Negative Pressure WoundTherapy and Advanced Wound Care

• For more than 10 years, V.A.C.® Therapy, also known as NPWT (Negative

pressure Wound Therapy), along with V.A.C. GranuFoam™ Dressings has setthe standard for wound healing. This body of evidence includes:

• The vast majority of published data related to NPWT products are based on theV.A.C. Therapy System with V.A.C. GranuFoam™ Dressings. The unique opencell, reticulated structure of the V.A.C. GranuFoam Dressings not onlydifferentiates the V.A.C. Therapy System from all other NPWT devices, theproprietary foam dressing under negative pressure creates an environment thatpromotes wound healing.

http://www.kci1.com/KCI1/vactherapyclinicalevidence






• Despite advances in surgical techniques and medical technology, managingcombat-related injuries remains challenging both within and outside thewar theater

• Military studies reported the use of NPWT/ROCF to treat contaminated softtissue injuries, open fractures, open joints, traumatic amputations,extremity wounds following reconstruction of the vascular and neuralstructures, wounds with exposed tendinous and osseous structures, openabdominal wounds, wounds on the back, chest and buttocks, partial

thickness burns, and over split-thickness skin grafts (STSGs) to promotegraft take

• Recent studies have reported on the beneficial use of NPWT/ROCF intemporizing combat wounds in preparation for delayed primary closure.Adjunctive use of the therapy has been shown to decrease time toclosure, reduce amputations, reduce infection, and decrease labor

required for dressing changes

• Geiger et al. reported use of NPWT/ROCF during OIF in 46% of admittedextremity wounds during March 2003, versus over 90% of admittedwounds during September 2003

Use of Vacuum-Assisted Closure NPWT in Combat Related Injuries

Use of Vacuum-Assisted Closure Negative Pressure Wound Therapy in Combat-Related Injuries -

Literature Review-Military Medicine, Mar 2010 by Hinck, Daniel, Franke, Axel, Gatzka, Friedrich



Cost Savings with VAC Therapy in Trauma Wounds

• There are 150,000 Trauma wounds annually that are appropriate fortreatment with VAC Therapy (NPWT)

70% (106,000) exist in Hospitals and LTAC The remaining 30% exist in SNF’s, WCC, HHA, PCP Offices

• An estimated 89,000 Trauma wounds were treated with NPWT in 2009

86% were treated in Hospitals and LTAC

The remaining 14% were are treated in SNF’s, WCC, HHA, PCP Offices

• Literature shows VAC Therapy may provide savings in trauma wounds of$31,842 (for Abdominal Compartment Syndrome patients) & savings of$33,040 (for Limb Salvage patients)

• This can account for an overall savings of up to $1.2M for Limb

Salvage Patients

1) L.E.K. - U.S. NPWT / V.A.C. Market Landscape

2) Kaplan M. Managing the open abdomen. Ostomy Wound Management, Vol.50, Issue 1a (Suppl), January

2004

3) The Economic Value of Negative Pressure Wound Therapy. Niezgoda JA, Mendez-Eastman S. Advances in

Skin and Wound Care. 2006 Jan/Feb;19(Suppl 1):3-15

4) NOTE: Hospital expenses were extrapolated from 2008 HCUP data. HCUP lists Acute daily hospital costs at

$1,993. See http://hcupnet.ahrq.gov/Days formula: 30-40.75 = 10.75. Expenditures formula: 10.75 *

$1,993.48 = $21,425



VAC Therapy Amputation Rates compared to rates wi thout

VAC Therapy

Use of Vacuum-Assisted Closure Negative Pressure Wound Therapy in Combat-Related Injuries - Literature Review-Military

Medicine, Mar 2010 by Hinck, Daniel, Franke, Axel, Gatzka, Friedrich

The Economic Value of Negative Pressure Wound Therapy. Niezgoda JA, Mendez Eastman S. Advances in Skin andWound Care. 2006 Jan/Feb;19(Suppl 1):3 15

NOTE: Hospital expenses were extrapolated f rom 2008 HCUP data. HCUP li sts Acu te dail y hospit al costs at $1,993. Seehttp://hcupnet.ahrq .gov/Days formul a: 30-40.75 = 10.75. Expendi tures formul a: 10.75 * $1,993.48 = $21,425

Limb Salvage-VAC Therapy Reduces Amputation Rates & AcceleratesWound Healing which can lead to savings

Number of Trauma Wounds 89000

Cost of an Amputation per patient $ 33,040

Limb Salvage Patients

Limb Salvage Patients VAC Therapy No VAC Therapy

Rate of Amputation 0.06 0.45

Savings (0.45-0.06) * $33,040* 89,000 $ 1,146,818,400



Benefits of VAC Therapy in Trauma Wounds:Reduced Amputations & Limb Salvage



Limb Salvage-VAC Therapy Reduces Amputation Rates & AcceleratesWound Healing

• Of the wounds sustained in OIF/OEF, an estimated 53-65% are extremity injuries.The majority of extremity injuries are soft-tissue wounds (53%), followed byfractures (26%)

• Typically, these types of injuries are survived and are therefore the focus ofprolonged wound treatment. Extremity injuries determine over 50% of surgicalprocedures and account for enormous economic costs as a result of long-termtreatment and rehabilitation

• Limited literature described amputation rates during the Vietnam War, withreported rates generally varying from 8% to 45% of major limb injuries

• In limb salvage, NPWT/ROCF has been used to help stabilize the wound, generatea healthy wound bed, decrease limb swelling, and prepare the wound for closure.Geiger et al. reported amputation in 4 of 62 patients (6%) and limb salvagerates of 93.6% at one of the busiest combat receiving hospitals. Peck et al.documented a 3% early amputation rate in 134 patients with combat-related

vascular extremity injuries

• Authors attributed improved limb salvage rates to advances in woundmanagement and reconstructive techniques. Evidence suggests reduced time toclosure may influence the functional outcome in limb salvage. Peck et al. observedthat NPWT/ROCF accelerated wound contraction and granulation formation, both ofwhich facilitated delayed primary closure or secondary coverage with skin grafting

Use of Vacuum-Assisted Closure Negative Pressure Wound Therapy in Combat-Related Injuries -Literature Review-Military Medicine, Mar 2010 by Hinck, Daniel, Franke, Axel, Gatzka, Friedrich



VAC Therapy Amputation Rates compared to rates wi thout

VAC Therapy

0.00%

5.00%

10.00%

15.00%

20.00%

25.00%

30.00%

35.00%

40.00%

45.00%

50.00%

Amputation Rate

45%

% A m p u t a t i o n

Use of Vacuum-Assisted Closure Negative Pressure Wound Therapy in Combat-Related Injuries - Literature Review-Military

Medicine, Mar 2010 by Hinck, Daniel, Franke, Axel, Gatzka, Friedrich

No V.A.C.® TherapyV.A.C.® Therapy

Limb Salvage-VAC Therapy Reduces Amputation Rates & AcceleratesWound Healing

6%



In another retrospective review of below knee amputation cases-Hospital days were lower by 82% for patients with

V.A.C.® Therapy vs. other standard wound care

A retrospect ive study of hospital ized patients prescribed

with possible below knee amputation yielded these results:

-

5

10

15

20

25

30

35

17days 31 days

D a y s

The Economic Value of Negative Pressure Wound Therapy. Niezgoda JA, Mendez Eastman S. Advances in Skin and

Wound Care. 2006 Jan/Feb;19(Suppl 1):3

15

(n= 10)

Other standard

wound care

V.A.C.® Therapy

(n= 10)

82%

Hospital days



In another retrospective review of below knee amputation cases-Hospital cost was lower by 45% for patients with V.A.C.® Therapy vs.

other standard wound care

A retrospect ive study of hospital ized patients prescribed

with possible below knee amputation yielded these results:

-

10,000

20,000

30,000

40,00050,000

60,000

70,000

80,000

$ 40,120 $ 73,160

U S D

The Economic Value of Negative Pressure Wound Therapy. Niezgoda JA, Mendez Eastman S. Advances in Skin andWound Care. 2006 Jan/Feb;19(Suppl 1):3 15NOTE: Hospital expenses were extrapolated f rom 2008 HCUP data. HCUP li sts Acu te daily hospi tal costs at $1,993. Seehttp://hcupnet.ahrq .gov/Days formul a: 30-40.75 = 10.75. Expendi tures for mula: 10.75 * $1,993.48 = $21,425

(n= 10)

Other standard

wound care

V.A.C.® Therapy

(n= 10)

45%

Hospital days: 17days

Hospital day: 31 days

Hospital Cost

Savings of

$33,040 perpatient



VAC Therapy Reduces Infections

• Wartime missile injuries are frequently high-energy wounds that devitalizeand contaminate tissue, with high risk for infection and wound

complications• Often the anecdotal infection rates are as high as 80%

• Wounds were closed definitively before discharge in all Iraqi patientstreated for such injures at our hospital. A novel wound managementprotocol was developed to facilitate NPWT, and patient outcomes weretracked

• Treatment and outcomes data from September 2004 through May 2005

were analyzed retrospectively• There were 88 high-energy soft tissue wounds identified in 77 patients.

• NPWT/ROCF provided protection of the wound from the ward environment,decrease in nursing labor time, and reduction of infection fromanecdotal 80% to documented 0%

• According to Leininger et al., the most significant benefit of NPWT/ROCF in

wartime extremity wound treatment was prolonged protection of thewound from the ward environment. The closed dressing system may helpminimize the spread of infection from host country to homeland treatmentareas, reducing the risk of nosocomial infection on both fronts.

Experience with wound VAC and delayed primary closure of contaminated soft tissue injuries in Iraq.Leininger BE, Rasmussen TE, Smith DL, Jenkins DH, Coppola C.

Use of Vacuum-Assisted Closure Negative Pressure Wound Therapy in Combat-Related Injuries - Literature

Review-Military Medicine, Mar 2010 by Hinck, Daniel, Franke, Axel, Gatzka, Friedrich



Benefits of VAC Therapy in Trauma Wounds:Reduced Time to Closure



VAC Therapy Reduces Time to Closure Rates

• During the first 4 months of OIF (2003), Geiger et al. showed a timefrom arrival to definitive closure of 12 days with NPWT/ROCFcompared to 17 days for patients not treated with NPWT/ROCF

• During the period of April to December 2005, time to wound closurehad decreased to an average of 3 days, based on limb edema andpresence of granulation formation

• Geiger et al. noted that earlier application of NPWT/ROCF in extremitywound treatment appeared to reduce time to closure. Considering thecostly nature of wartime missile injuries in terms of personal andfinancial resources, reducing time to closure may result in costsavings to the system

• Leininger et al. observed that length of hospital stay was substantially

reduced with NPWT/ROCF compared to closure via secondaryintention or delayed grafting, and reported a mean time to closure of4 days in 77 Iraqi patients with 88 soft-tissue wounds





3

12

17

0

2

4

6

8

10

12

14

16

18

V.A.C.® Therapy Apr-Dec 2005

V.A.C.® TherapyJan-Apr 2005

No V.A.C.®Therapy

V.A.C® Therapy Reduced Wound Healing Time by 14 days

A retrospective chart review of 62 patient with extremi ty injuriesyielded the results below:

D a y s

Use of Vacuum-Assisted Closure Negative Pressure Wound Therapy in Combat-Related Injuries - Literature Review-

Military Medicine, Mar 2010 by Hinck, Daniel, Franke, Axel, Gatzka, Friedrich

Geiger et al. War wounds: lessons learned from Operation Iraqi Freedom. 2008

NPWT=62

14days



Benefits of VAC Therapy in Trauma Wounds:Reduced Nursing Time



VAC Therapy Reduces Nursing Time

• Reported frequency between NPWT/ROCF dressing changes variedfrom 2 to 4 days, as opposed to the prior regimen of 2-3 times dailybedside gauze dressing changes. Authors reported the reduceddressing change frequency allowed time to perform NPWT dressingchanges in the cleaner, OR environment

• Machen et al. recommended that NPWT/ROCF systems be available inall combat support hospitals tasked with managing large numbers of

combat patients for extended time. Studies reported NPWT/ROCFincreased productivity and time for surgeons to treat more criticalpatients. Reduced bedside nursing time may indicate cost savings. Inevacuee cases, the 1 to 2 day interval between dressing changescould be the length of evacuation, allowing therapy initiation in thefield followed by the first dressing change in the home country





2.9

6.3

0

1

2

3

4

5

6

7

Nursing hours

V.A.C.® Therapy Modrern Wound Dress.

V.A.C® Therapy Reduces Nursing Hours by54% Compared to Modern Wound Dressings

A randomized control trial of acute and chronic wound

patients yielded the results below:

H o u r s

Braakenburg A, Obdeijn MC, Feitz R, van Rooij IA, van Griethuysen AJ, Klinkenbijl JH. The clinical efficacy

and cost effectiveness of the vacuum-assisted closure technique in the management of acute and chronicwounds: a randomized contro lled trial. Plastic and Reconstruct ive Surgery. 2006 Aug;118(2):390-7

P =0.04, NPWT=32, MWT=33

54%

Hydrocolloid, Alginate, Eusol



Benefits of VAC Therapy in Trauma Wounds:Faster Time to Fascial Closure in ACSPatients

23



Abdominal Compartment Syndrome-Causes

Blunt Trauma

• Rapid deceleration (motorvehicle crash) results inavulsion of the smallbranches of major vessels

• A blow to the major vessels

can result in an internal tearleading to vessel rupture

• Damage to organs can resultin massive hemorrhaging orloss of organ contents suchas feces or digestive enzymes

Penetrating Trauma

• Occurs from a stab,impalement or missile

24



Complications Associated with ACS

• Retraction & loss of fascia• Retraction & loss of rectus

abdominus muscle

• Necessitates placement ofabdominal mesh for herniacontrol and stability of

abdominal contents.

• Maintaining a clean woundenvironment

• Abdominal trauma

• Hemorrhage

• Peritonitis• Emergency aortic surgery

• Intra abdominal packing

• Forced abdominal closure, etc.

Photo: Kaplan M et al. Guidelines for the Management of theOpen Abdomen. Recommendations f rom a multidisciplinaryexpert advisory panel. Wounds, a compendium of clinicalresearch and practice Supplement, 1-22 (2005).

25



Abdominal Compartment Syndrome

• Patients with open abdomens have 30 – 40% chance ofdeveloping multi-organ failure

• Overall mortality rate open abdomen > 25%

• Incidence of abdominal dehiscence (following anylaparotomy): 0.4 – 3% with a mortality rate of 15-20%

• Incidence ACS: 15% in cases of acute abdominal trauma

with a 62.5% mortality rate

• One of the major cost drivers in treating an open abdomen isthe length of ICU stay

• Treatment costs estimated between $33,800 – $232,000

• Swan M, Banwell PE. Topical Negative Pressure: Advanced Management of the Open Abdomen. The OxfordWound Healing Society. 2003.

• Kaplan, et al. Guidelines for the Management of the Open Abdomen: Recommendations from a multidisciplinaryexpert advisory panel. Suppl Wounds Oct 2005

26



The goal of open abdomen procedures is trendingtoward achieving primary fascial closure

• Awareness of intra-abdominal hypertension, abdominalcompartment syndrome and abdominal infections has led toincreased frequency of open abdomen procedures.

• Leaving the abdomen open has been shown to increase

survival.

• Cost savings and better quality of life outcomes are shiftingthe treatment paradigm toward achieving primary closureduring the same admission versus the traditional goal of aplanned hernia with reconstruction.

27



ABThera™ Open Abdomen Negative PressureTherapy System

A Temporary Abdominal Closure system that helpsyou take control early when managing a challenging

open abdomen and achieve primary fascial closure.

Actively removes fluid and helps reduce edema

Provides medial tension which helps minimizefascial retraction and loss of domain4

Helps isolate viscera and abdominal contentsfrom external environment

Provides separation between the abdominal walland viscera, protecting abdominal contents

Removes fluid and infectious materials from theabdomen

Allows rapid access for re-entry and does notrequire sutures for placement

28



VAC Therapy Improves Fascial Closure Rates by 21%

0

10

20

30

40

50

60

70

80

90

Polypropylene

Polyglactin/

polyglycolic

Bogotabag

Vacuumpack

V.A.C.®

Therapy™

P e r c e n t a

g e f a s c i a l c l o s u r e

p <0.001

Total patients wi thfacial closure N= 545(43%)

Compilation of data various TAC techniques formanaging the open abdomen

79

58

18

3344

Kaplan M, et al. Guidelines for t he Management of the Open Abdomen. Recommendations from amultid iscip linary expert advisory panel. Wounds, a compendium of clinical research and practi ce. Suppl, 1-

22 (Oct 2005).

VAC Th d ICU d til t d &29



VAC Therapy reduces ICU days, ventilator days &hospital LOS leading to cost savings

0

5

10

15

20

25

30

35

40

45

ICU days Ventilator days Hospitals days

D a y s

19 26 12.75 20 30 40.75

p < 0.05

V.A.C.® Therapy

Vacuum pack

Kaplan M. Negative pressure wound therapy versus V.A.C.® Therapy – a two year study of patients at highrisk fo r ACS. Abstract presentation. First International World Congress on Abdominal CompartmentSyndrome. Australia. December 6-8. 2004

310000

320000

330000

340000

350000

360000

370000

U S

D ( $

)

326,734358,576

Total cost savings for

V.A.C.® Therapy: $31,842

Kaplan M. Managing the open abdomen. Ostomy Wound Management, Vol.50, Issue 1a (Suppl ), January 2004



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SOURCE: L.E.K. - U.S. NPWT / V.A.C. Market Landscape

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