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Volume 19, Number 1, January 2007 Differentiating Negative Pressure Wound Therapy Devices: An Illustrative Case Series Editor: Subhas Gupta, MD, CM, PhD, FRCSC, FACS Supplement to WOUNDS This supplement is supported by a grant from the Loma Linda University Division of Plastic Surgery.

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Page 1: Differentiating Negative Pressure Wound Therapy · PDF fileDifferentiating Negative Pressure Wound Therapy Devices: An ... method of treating a variety of acute and chronic wound types

Volume 19, Number 1, January 2007

Differentiating Negative PressureWound Therapy Devices: AnIllustrative Case Series

Edi to r : Subhas Gupta , MD, CM, PhD, FRCSC, FACS

Supplement to WOUNDS

This supplement is supported by a grant from theLoma Linda University Division of Plastic Surgery.

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Subhas Gupta, MD, CM, PhD, FRCSC, FACS, is the chairman of the technol-

ogy assessment panel and the editor of this supplement.Dr.Gupta is the Chairman

and Program Director of the Division of Plastic Surgery at Loma Linda University

and Loma Linda University Medical Center, Loma Linda, Calif. He is board certified

in plastic surgery and a member of the American Society of Plastic Surgeons. His

current research projects explore advanced technologies in wound care.

Barbara Bates-Jensen, PhD, RN, CWOCN, is Assistant Professor at UCLA

School of Nursing and the Division of Geriatrics School of Medicine in Los Angeles,

Calif.She is a past Vice President for the National Pressure Ulcer Advisory Panel and

the co-editor of Wound Care: A Collaborative Practice Manual for Health Care

Professionals, 3rd edition. Her research focuses on the quality of pressure ulcer

care in nursing homes.

Allen Gabriel, MD, is from the division of plastic surgery at Loma Linda

University, Loma Linda, Calif. Dr. Gabriel has conducted several studies on negative

pressure wound therapy (NPWT) with focuses on infected and pediatric wounds

as well as large surgical defects. He has multiple active research studies investigat-

ing the mechanism of action of NPWT and other advanced wound care modalities.

Allen Holloway, MD, RVT, is the Director of Burn Outpatient Services and

Director of the Vascular Lab at Maricopa Medical Center in Phoenix, Ariz. He is

board certified in internal medicine, is adjunct Professor of Bioengineering at

Arizona State University, and is President-Elect of the Wound Healing Society with

research interests in new technology and clinical aspects of wounds and burn care.

Jeffrey A. Niezgoda, MD, FACHM, FACEP, is board certified in emergency

medicine and hyperbaric medicine. He serves as the Medical Director for the

Centers for Comprehensive Wound Care and Hyperbaric Oxygen Therapy and

Aurora Health Care and is President of Hyperbaric and Wound Care Associates,

Milwaukee,Wisc.He is also an Associate Professor in the Department of Neurology

at the Medical College of Wisconsin and Vice President of the American College of

Hyperbaric Medicine.

Dot Weir, RN, CWON, CWS, is a board-certified wound and ostomy nurse as

well as a certified wound specialist. She is the Clinical Coordinator for Wound Care

at Osceola Regional Medical Center in Kissimmee, Fla. She is a member and past-

president of the Association for the Advancement of Wound Care (AAWC), a mem-

ber of the Wound, Ostomy and Continence Nurses Society, and Secretary of the

Florida Association of Enterostomal Therapists.

Loma Linda Skin and Wound CareTechnology Assessment Panel Members:

EDITORIAL STAFF

MANAGING EDITOR Michael McGovern

ASSOCIATE EDITOR Chimere Holmes

SPECIAL PROJECTS EDITOR Renee Olszewski

SPECIAL PROJECTS EDITOR Stefanie Tuleya

DESIGN AND PRODUCTION

PRODUCTION DIRECTOR Kathy Murphy

PRODUCTION DIRECTOR, SPECIAL PROJECTSKimberly Chesky

CREATIVE DIRECTOR Vic Geanopulos

LAYOUT/PRODUCTION MANAGER Andrea Steiger

CIRCULATION MANAGER Bonnie Shannon

CIRCULATION CLERK Jennifer Cooper

BUSINESS STAFF

PUBLISHER Jeremy Bowden

NATIONAL SALES MANAGER Matthew Tucker

NATIONAL SALES MANAGER Kevin Franey

PROJECT MANAGER Kristi Shelly

EDITORIAL AND PRODUCTION OFFICES: HMPCommunications, 83 General Warren Blvd.,Suite 100, Malvern, PA 19355, Phone 800-237-7285 or 610-560-0500

© 2007 HMP Communications. All rights reserved. Opinionsexpressed by authors, contributors, and advertisers are their ownand not necessarily those of HMP Communications, the editorialstaff, or any member of the editorial advisory board. This mate-rial was submitted as a supplement and was not reviewedby the journal editor or the WOUNDS editorial advisoryboard.

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Negative pressure wound therapy (NPWT) has become a popularmethod of treating a variety of acute and chronic wound types overthe past decade.Until recently, there has been only one US Food and

Drug Administration (FDA)-cleared commercial device for delivering NPWT,the Vacuum Assisted Closure™ device (V.A.C.® Therapy,KCI,San Antonio,Tex).A competing product called the Versatile 1™ (BlueSky Medical, Carlsbad,Calif) was approved in 2004. Since then, patients treated with the newerdevices have presented to the authors’ practices for additional management.

Two recent cases with unexpected results (Case 3 and Case 4) promptedthe Loma Linda Skin and Wound Care Technology Assessment Panel to eval-uate the differences between V.A.C.Therapy and the Versatile 1 with respectto approved indications and peer-reviewed clinical efficacy reports and tri-als. Long-term NPWT users with broad experience in wound care and strongacademic backgrounds were invited to participate as members of the panel.The panelists reviewed an extensive library of publications on NPWT as wellas information requested from and provided by both manufacturers.Panelists also reviewed cases from their practices that exemplify contrastingefficacy of the technologies.

Vacuum therapy has been used for the treatment of open wounds fornearly a century. Beginning in 1908 with Bier’s Hyperemic Treatment,1 cli-nicians have applied vacuum suction to infections and all types of chronic,traumatic, and post-surgical wounds. More contemporary uses of vacuumsuction were described in the 1970s in Russian literature2–6 andFleischmann’s work7,8 followed by case studies described by Chariker, Jeter,and Tintle9 in 1989. In 1993, the FDA cleared “VAC therapy” for marketing

Differentiating Negative PressureWound Therapy Devices: AnIllustrative Case Series

Subhas Gupta, MD, CM, PhD, FRCSC, FACS;1 Barbara Bates-Jensen, PhD, RN, CWOCN;2 Allen Gabriel, MD;1 AllenHolloway, MD, RVT;3 Jeffrey Niezgoda, MD, FACHM, FACEP;4

Dot Weir, RN, CWON, CWS5

WOUNDS 2007;19(1 Suppl):1–9

From 1the Division of PlasticSurgery, Department of Surgery,Loma Linda University, Loma Linda,California; 2UCLA School of Nursingand the Division of GeriatricsSchool of Medicine, Los Angeles,California; 3Maricopa MedicalCenter, Phoenix, Arizona; 4Centersfor Comprehensive Wound Care andHyperbaric Oxygen Therapy andAurora Health Care, Milwaukee,Wisconsin; 5Osceola RegionalMedical Center, Kissimmee, Florida

Address correspondence to:Subhas Gupta, MD, CM, PhD,FRCSC, FACS,Division of Plastic Surgery,Department of Surgery, Loma LindaUniversity, 11175 Campus Drive,Coleman Pavilion 21126, LomaLinda, CA 92354Phone: 909-558-8085;Fax: 909-558-4175;E-mail: [email protected]

Abstract: Negative pressure wound therapy (NPWT) has become animportant addition to the vast number of wound treatments availableto the clinician. The two NPWT devices most commonly used in theUnited States have different components, features, and capabilities.Several cases of wounds treated with each of the two most commonlyused devices are presented. Indications and evidence for use of bothdevices are evaluated and safety guidelines are recommended. TheLoma Linda Skin and Wound Care Technology Assessment Panel com-missioned the study.

Vol. 19, No. 1 January 2007 1

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purposes and use in wounds.The system included a ster-ile, open-cell foam dressing that was placed into awound, sealed with an adhesive drape, and then exposedto subatmospheric pressure applied through attachedtubing. Evidence of improved wound healing, increasedgranulation tissue formation, and decreased bacterialload was noted.10

Currently, the most common term for vacuum tech-nology is NPWT. While there are presently severaldevices approved for NPWT, the two most frequentlyused are V.A.C.Therapy and the Versatile 1.Although orig-inally given FDA clearance in 1993, the approved indica-tions for V.A.C. Therapy have expanded considerablysince its inception due to ongoing research and expand-ed clinical experience with the device (Table 1). V.A.C.Therapy is currently approved for use in preparing thewound bed for closure, reducing edema,promoting gran-ulation tissue formation and perfusion, and removingexudate and infectious material in the wound types list-ed in Table 1. In contrast, the Versatile 1 is approved foruse as a wound suction device, and no specific woundtypes are included in the FDA indications for use.

The basic components of each device11, 12 are a suc-tion pump, tubing, sealing apparatus, and wound inter-face dressing (Table 2). Both pumps are capable of con-tinuous and intermittent suction, although typical treat-ment ranges vary. The recommended daily therapy forV.A.C. Therapy is 22–24 hours of suction at 75–125mmHg to prevent the wound exudate from becoming

stagnant in the wound bed and potentially becoming anidus for infection.The Versatile 1 clinical protocol rec-ommends a continuous pressure of 60–80 mmHg andchecking for dressing integrity every 6 hours or onceper nursing shift but does not recommend a number ofhours for treatment per day. Unpublished posters andmanufacturer information on case studies using Versatile1 describe maintaining suction on the wound for 6–8hours per day and leaving the dressing undisturbed forthe remainder of the 24 hours.The tubing and canistersystem of V.A.C.Therapy is preassembled and sealed toprevent contamination of the wound. The Versatile 1tubing-canister system is user assembled, including con-nection of the filter.The adhesive drape is similar in bothproducts. In addition, another version of V.A.C.Therapy,known as the V.A.C.® Instill® System, combines the func-tion of the standard V.A.C. device with timed, intermit-tent delivery of an instilled topical solution. The majordifference in the two devices is the wound interface.The Versatile 1 is used with gauze dressings. V.A.C.Therapy has two types of foam with varying pore sizesand densities. Evidence suggests that when the foam inthe wound bed is exposed to pressure, microdeforma-tional forces promote tissue changes, which increasegranulation tissue formation.13 There is no evidence todate that demonstrates that gauze under pressureimproves granulation tissue formation.

The safety and contamination control features for bothproducts11,12,14 are detailed in Table 2. The V.A.C. devicesinclude alarms that warn of breaches in the dressingintegrity as well as machine malfunction.The Versatile 1products also have alarms indicating machine malfunc-tion, and the new V1STA™ Versatile 1 Portable providesusers with protection against high vacuum.Contamination control is always a concern when using avacuum device on an open wound. A critical differencebetween the products is that the V.A.C.canister and tubingare one piece, disposable, and have a gel pack in the can-ister—features that prevent evacuated wound fluid fromre-entering the wound.The Versatile 1 tubing-canister-filtersystem must be assembled by the user, with a correspon-ding greater potential for contamination or malfunction ifinappropriately connected or if dislodged.

The V.A.C. device comes with explicit clinicalguidelines for use, and detailed instructions for use arealso provided with V.A.C. dressings. The Versatile 1products include general guidelines for use that donot include instructions on duration of use per day orwound-specific application. The clinical support for

Gupta et al

2 WOUNDS A Compendium of Clinical Research and Practice

V.A.C. Therapy Versatile 1

The V.A.C. Therapy Systemis intended to create anenvironment that promoteswound healing by second-ary or tertiary (delayed pri-mary) intention by prepar-ing the wound bed for clo-sure, reducing edema, pro-moting granulation tissueformation and perfusion,and removing exudate andinfectious material. It isindicated for patients withchronic, acute, traumatic,subacute, and dehiscedwounds, partial-thicknessburns, ulcers (such as dia-betic or pressure), flaps,and grafts.

The Versatile 1 is indicat-ed for patients who wouldbenefit from a suctiondevice particularly as thedevice may promote woundhealing or for aspirationand removal of surgicalfluids, tissue (includingbone), gases, bodily fluids,or infectious materialsfrom a patient’s airway orrespiratory support systemeither during surgery or atthe patient’s bedside.

Table 1. Currently approved indications of NPWT devices

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the devices is also quite different. V.A.C. Therapy hassubstantial field support with wound care expertise tohelp ensure products are used safely and effectively. Inaddition to field clinical support, there are publishedguidelines developed by interdisciplinary panels ofexperts in wound care for safe and effective use ofV.A.C. Therapy for specific wound types, includingchronic wounds, diabetic foot ulcers, pressure ulcers,chest and sternal wounds, and open abdominalwounds.15–19

Hundreds of reports have been published on the useof NPWT in peer-reviewed journals with the majority ofstudies providing information on NPWT with V.A.C.Therapy.As of November 2006, evidence specifically sup-

porting V.A.C. Therapy includes at least 14 randomized,controlled clinical trials, 2 prospective controlled studies,14 comparative retrospective studies, 39 retrospectivestudies, 69 case series, 98 individual case studies, 19 basicscience articles, and 2 economic studies as well as multi-ple reviews and papers outlining therapy description.Evidence supporting use of the Versatile 1 as of the samedate are limited to 1 case series, 6 individual case studies,most in the form of poster presentations, 3 therapydescriptions, and posters of wounds including abdominalfistulas,dehisced abdominal wounds, diabetic foot ulcers,and amputations.20–24 Studies using the V.A.C. device haveaddressed all wound types, including burns, diabetic footulcers, skin grafts and flaps, orthopedic trauma, medias-

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Vol. 19, No. 1 January 2007 3

KCI BlueSky

Suction•Mode•Typical treatment

range•Recommended therapy

Tubing•Canister/tubing•Pressure sensing

Sealing•Drape•Bridging§

Dressing•Material†

• Infection control•Type• Instillation

Safety•Alarms

•Guidelines for use

Contamination Control•Canister•Filter

•Other

•Continuous and intermittent•75–125 mmHg

•22 hours/day

•Preassembled •Feedback loop

•Adhesive drape•Bridging available

•Reticulated and nonadherent foam

•Antimicrobial dressing available•Anatomic and application specific dressings •Available

•Canister full, tubing blocked, leak, therapynot activated, low battery

•Explicit for pressure settings, treatmenthours per day, indications andcontraindications

•Preassembled, closed, disposable•Charcoal filter, hydrophobic filter inside canister

•Isolyzer (absorbent gel pack inside canister)

• Continuous and intermittent• 60–80 mmHg

• 6–8 hours/day

• User assembled• Alarms if pressure is too high or too low

• Adhesive drape• Bridging unknown

• Gauze with nonadherent contact layeravailable

• Antimicrobial gauze available• Multiple gauze dressing kits• Available

• Overflow, low and high vacuum, lowbattery

• Suggested for pressure settings, indica-tions and contraindications; no guide-lines for treatment hours per day

• User assembled• External bacteria/overflow filter

• Isolyzer available

Table 2. Overview of NPWT devices*

*Information obtained from published data and manufacturer information§Bridging 2 wounds in close proximity to one another: protect skin between the 2 wounds with a piece of V.A.C. drape oranother skin barrier. Fill both wounds with foam, and then connect the 2 wounds with an additional piece of foam, like abridge. All foam pieces must come into contact with each other. The tubing is placed in a central location to ensure exu-date from 1 wound is not being drawn across the other wound. Bridging can also be used for dressing small wounds,such as those on the plantar surface or heel of the foot.11

†For all devices, a variety of nonadherent dressings are used in practice.

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tinitis, pressure ulcers, and open surgical and dehiscedwounds. In addition, there are over 100 more publishedreports on other types of wounds and animal studies.25–35

Because all the FDA-cleared vacuum therapy devicesare approved to provide NPWT,there is a perception thatthe therapies are equivalent.All NPWT is not equal, andclearly, more studies are needed comparing the differentmodalities.The following case series includes examplesof wounds treated with both devices. In some instances,V.A.C. Therapy was instituted at an acute care facility,only to be changed over to the Versatile 1 when thepatient was transitioned to long-term or home care.Wound deterioration was noted in these cases. Includedin the case studies are pressure ulcers, abdominalwounds, diabetic foot ulcers, and burns.

Case 1An 11-year-old boy presented to the emergency room

with a lower-extremity soft tissue avulsion injury andopen tibia/fibula fracture following a motor vehicle acci-dent (Figure 1A).The patient was taken to the operatingroom for debridement and external fixation of a large softtissue deficit with heavy contamination of exposed bone,muscle, and tendon. A silver-impregnated polyurethanefoam dressing was applied directly over the wound with-out a nonadherent layer.V.A.C.Therapy was initiated at 125

mmHg on continuous mode. OnDay 7, a split-thickness skin graftwas applied and bolstered with sil-ver-impregnated polyurethane foamdressing without a nonadherentlayer, and V.A.C. Therapy wasapplied at 75 mmHg on continuousmode.The dressing was removed onDay 3, and there was 100% grafttake and complete wound healing(Figure 1B).

Case 2A 13-year-old boy presented to the emergency room

following blunt abdominal trauma (Figure 2A). Afterbeing diagnosed with abdominal compartment syn-drome, the patient underwent emergency decompres-sion, and V.A.C.Therapy was initiated with an abdominalcompartment syndrome dressing system. A perforated,nonadherent layer was folded in around the viscera, anda polyurethane foam dressing was placed over the non-adherent layer and covered with a semi gas-permeabledrape.V.A.C.Therapy was initiated at 125 mmHg on con-tinuous mode (Figure 2B). The goal of therapy was toactively remove third space fluid, control the potentialvisceral space, and maintain a closed wound system inpreparation for delayed primary closure. The surgicalteam performed multiple dressing changes using sterilesurgical technique. After the edema resolved, theabdomen was closed via delayed primary closure (Figure2C).The patient had an uncomplicated recovery and wasdischarged home on post-trauma Day 22.

Case 3The patient was a 57-year-old Hispanic woman with a

history of type II diabetes, hypertension, end-stage renaldisease, and a below-knee amputation of the right leg.Thepatient reported a history of a fall onto her left leg with

Gupta et al

4 WOUNDS A Compendium of Clinical Research and Practice

Figure 1. Case 1: open lower-extremity fracture managed effectively with V.A.C. Therapy.

Figure 2. Case 2: abdominal compartment syndrome managed successfully with V.A.C. Therapy.

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subsequent hematoma requiring evacuation and debride-ment 3 weeks prior to presenting to the outpatient woundcenter secondary to lack of progress of healing. Thepatient had been in a local skilled nursing facility undertreatment with the Versatile 1 for 16 days (Figure 3A).Thedressing, which consisted of an oil emulsion dressing inthe wound bed, a Jackson-Pratt drain, gauze, and a trans-parent film dressing, was removed (Figure 3B and 3C).Initial evaluation of the wound revealed little viable tissueevident and a relatively dry wound bed consisting prima-rily of moist yellow and dry dark slough (Figure 3D).Thewound bed was debrided (Figure 3E), revealing 14 mm ofundermining on the medial edge of the wound.The rec-ommendation was made to change the patient’s NPWT toV.A.C., and the facility agreed. Subsequent visits revealedmore than acceptable resolution of the undermining andimprovement in the wound bed.The V.A.C. was discontin-ued after 5 weeks, and the wound healed completelyshortly after V.A.C. discontinuation.

Case 4A 72-year-old man with a history of exploratory laparo-

tomy presented with a dehisced surgical wound.At the timeof his initial wound care consultation, the patient under-went sharp debridement (Figure 4A) and was placed on theVersatile 1. The patient returned for follow-up after one

week (Figure 4B).The malodorous soiled gauze (Figure 4C)and the drain (Figure 4D) were removed.At the time of thenext weekly follow-up visit, the patient was noted to havean area of fluctuance at the inferior wound margin.Exploration of this area revealed a periwound subdermalabscess (Figure 4E).The abscess was drained and the necrot-ic wound was again sharply debrided.Versatile 1 was dis-continued because of the deterioration,and the patient wasplaced on NPWT using V.A.C.Therapy.A comparative viewof the wound after 2 weeks of treatment with each NPWTdevice is shown in Figure 5.Excellent healing occurred afterseveral weeks of V.A.C.Therapy.

Case 5A 48-year-old man with diabetes and history of right

diabetic foot ulcer presented with a nonhealing dorsalfoot wound. He was taken to the operating room forwound debridement. The patient was started on V.A.C.Therapy, and after the first dressing change on post-operative Day 3, he was transitioned to home V.A.C.Thepatient, however, was started on Versatile 1 by the homecare team, unknown to the treating physician. Thepatient presented in follow-up 10 days after dischargewith a sealed moist gauze in the wound bed. Afterremoval of the gauze and drain, necrotic tissue wasnoted. He was admitted, the wound was debrided, and

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Vol. 19, No. 1 January 2007 5

Figure 3. Case 3: diabetic lower-extremity wound treated with Versatile 1 and salvaged with V.A.C. Therapy.

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he was placed on V.A.C. Therapy for 10 days until thewound was ready for split-thickness skin grafting. Hewas successfully skin grafted and discharged home witha closed wound.

Case 6A 50-year-old woman was hospitalized with bilateral cel-

lulitis of the feet 2 weeks after suffering bilateral partial-thickness contact burns on the soles of her feet. Over thecourse of 2 weeks, the patient underwent multiple tangen-tial excisions and debridements with fasciotomies of theright first, second, fourth,and fifth metatarsals, leaving deepopen wounds.She was also diagnosed with diabetes,whichwas well controlled. After the final debridement, V.A.C.

Therapy was started, and she was discharged to home.Unknown to her caregivers at the hospital,she was changedfrom the KCI V.A.C. to a BlueSky Versatile 1 device immedi-ately following discharge.At her clinic appointment 5 dayslater, the BlueSky device was in place on the plantar aspectof both feet with a gauze sponge, Jackson-Pratt drain, and afilm dressing covering.The wounds were heavily maceratedand filled with thick,opaque,foul smelling liquid.Both wereclinically infected, and she was readmitted to the hospitalfor intravenous antibiotics and wound care.After aggressivetreatment with whirlpool and debridement, the woundsimproved, and she was again discharged with a V.A.C.device. Over the next 2 1⁄2 months, she developed healthygranulation tissue in the wound, and the V.A.C. was eventu-ally changed over to moist surface dressings.Complete heal-ing of both feet occurred within the next month, and shereturned to normal ambulation.

Case 7A 42-year-old man with long-term paraplegia was

admitted to the hospital for surgical management of anischial ulcer and debridement of a sacral pressure ulcer.Three days following surgery, the patient was dischargedto an extended care facility on NPWT with V.A.C.Therapyfor the sacral wound. However, the patient’s device wasswitched to Versatile 1, and he presented to the emer-gency room with fever and chills 3 weeks post-discharge.Examination of the wound showed periwound cellulitiswith gauze and drain in place. Upon removal of the

Gupta et al

6 WOUNDS A Compendium of Clinical Research and Practice

Figure 5. Case 4: comparative view of abdominal woundafter 2 weeks of treatment with each NPWT device.

Figure 4. Case 4: abdominal surgical wound dehiscence treated with Versatile 1.

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gauze, necrotic tissue was evident at the base of thewound with purulent drainage. The patient was admit-ted, underwent operative re-debridement of the wound,and was placed on V.A.C. Therapy. The wound healedcompletely within 6 weeks.

DiscussionThe term NPWT is pervasive in the wound healing lit-

erature and market. Clinicians choosing to use NPWTshould know the difference among the devices, includ-ing differences in indications and appropriate woundtypes for use. Negative pressure wound therapy deviceshave different wound interface materials, safety features,and recommended applications.V.A.C.Therapy has beenstudied extensively in all wound types.The Versatile 1 hasnot been studied as rigorously, and its appropriatenessfor all wound conditions is unknown.

The cases presented provide support that there aredifferences in NPWT (Table 3). Case 4 demonstratesobservational case-controlled clinical differencesbetween the devices, including discrepancy in granula-tion tissue formation and wound complications.

Several of the presented case studies illustrate experi-ences when Versatile 1 was substituted for V.A.C.Therapyin the long-term care setting. By necessity, patients musttransfer out of the acute care setting while still onadvanced wound care therapy, resulting in changes incaregivers and, therefore, often changes in wound treat-ment. Because of insurance reimbursements and facilityprotocols, a less expensive therapy (cost per treatmentday, not cost to closure analysis) is occasionally useddespite the prescribing physician’s preference. Becauseall of these devices are considered to be NPWT, somefacilities use devices interchangeably, without considera-tion of the evidence behind individual device types andthe potential consequences. In turn, a lack of communi-cation with the prescribing clinician and lack of properoversight of the therapy can produce major wound com-plications with significant morbidity.

In order to avoid wound deterioration, the panel rec-ommends that clinicians know the difference among theNPWT devices including appropriate use of individualNPWT devices. The following questions should be con-sidered prior to commencement of NPWT.

Summary Questions11.. HHooww oofftteenn sshhoouulldd ppaattiieennttss oonn NNPPWWTT bbee eevvaalluuaatteedd

aanndd oonn wwhhaatt ccrriitteerriiaa sshhoouulldd ttrreeaattmmeenntt bbee bbaasseedd??Patients on NPWT should be evaluated at each dress-

ing change by a clinician experienced with woundtherapy and at least every other week by a woundcare specialist. Careful wound measurements shouldbe recorded weekly to follow wound progress. Ifwound measurements have not improved at least 10%per week or have worsened, the therapy may not beappropriate. It has also been recommended that a 50%improvement in wound size over 4 weeks is a goodindication that the therapy is working and that thewound will heal.36 In addition,careful attention shouldbe paid to the development of worsening infection,necrotic tissue, and uncontrolled bleeding with theuse of NPWT.

22.. WWhhaatt iiss tthhee eevviiddeennccee ssuuppppoorrtt ffoorr ttrreeaattmmeenntt hhoouurrss ppeerrddaayy?? Evidence supports the use of negative pressurefor 22 hours per day.There appears to be no evidenceto support use for shorter periods of time. Recentresearch indicates that the ability of a dressing to con-form to the contours of a wound is important toreduce areas of noncontact where bacteria may pro-liferate.37 Continuous NPWT maintains conformabilityof the interface to the wound bed, minimizing poten-tial glycocalyx.The porous nature of a foam in a nega-tive pressure environment also allows for compres-sion and conformity to the entire wound surface.

33.. WWhheenn sshhoouulldd NNPPWWTT bbee ssttooppppeedd?? When the treatmentgoal is met or any of the conditions in question 1 arepresent, NPWT should be stopped. In some cases,NPWT can be used until wound closure, although inmost cases, it is used until the wound is filled withgood granulation tissue and ready for skin graft or flapor standard wound therapy.

44.. WWhhaatt aarree tthhee aaddvvaannttaaggeess ooff tthhee ddeevviiccee iinntteerrffaacceess aavvaaiill--aabbllee?? Scientific evidence supports that microstrainresults when an open cell, reticulated foam dressing isused in conjunction with negative pressure.There isno evidence to support that this occurs with gauzeunder pressure. Also, the hydrophobic nature of theV.A.C. foam allows exudate and infectious materials tobe readily removed, while gauze absorbs this samefluid, keeping it in contact with the wound bed, par-ticularly if NPWT suction is not used for extendedperiods daily.

55.. HHooww ddoo yyoouu mmiinniimmiizzee wwoouunndd bbeedd ccoonnttaammiinnaattiioonnffrroomm tthhee ddeevviiccee?? The NPWT device should beequipped with an adequate filtration device andshould be a closed drainage system with little risk ofbeing dislodged.There should be consistent suction atall times.

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Vol. 19, No. 1 January 2007 7

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66.. HHooww ddooeess oonnee cchhoooossee tthhee aapppprroopprriiaattee NNPPWWTT ddeevviiccee??Choosing the right NPWT device should be based oncareful consideration of the specific FDA indicationsfor use (Table 1), the amount of clinical evidence, andavailability of clinical support.

RecommendationsThe Loma Linda Skin and Wound Care Technology

Assessment Panel makes the following recommendations:• Appropriate wound bed preparation is always para-

mount• Review and follow indications for NPWT devices and

be sure they are appropriate for wound type andpatient condition

• Indications are not the same for all NPWT devices• Careful oversight of patients’ care as they transition to

different inpatient or outpatient settings is necessary• Monitor the wound consistently and weekly to assess

wound progression toward goal of therapy.

ConclusionOver the last decade, NPWT has been established as a

well defined wound care option in treating complexacute and chronic wounds and, in many instances, hasbecome the standard of care. However, different devicesclaim to deliver NPWT.They do not have the same effi-cacy and indications. Given the differences between thetechnologies, each system was reviewed in the contextof evidence-based medicine.There is a substantial body

of peer-reviewed evidence supporting the use of KCI’sV.A.C. in numerous wound types, but the panel wasunable to conclude that the BlueSky Versatile 1 had evi-dence supporting its use in wound management.Additionally, the panel’s case series highlights cases inwhich the V.A.C. was required for salvage of Versatile 1-treated wounds that had deteriorated.The panel expectsto see the unveiling of addional products deliveringNPWT,and it shall be left to the individual practitioner touse his or her clinical judgment and review the evidencein order to provide patients with the most efficaciousand safe modality available on the market.

References1. Meyer W, Schmieden V. Bier’s Hyperemic Treatment.

Philadelphia and London: WB Saunders Company;1908:78–153.

2. Kostiuchenok BM, Kolker II, Karlov VA, Ignatenko SN,Muzykant LI, Samykina TD.The vacuum effect in the sur-gical treatment of purulent wounds. Vestnik Khirurgii.1986;9:18–21.

3. Davydov YA, Malafeeva AP, Smirnov AP, et al.Vacuum ther-apy in the treatment of purulent lactation mastitis.Vestnik Khirurgii. 1986;9:66–70.

4. Usupov YN, Yepifanov MV. Active wound drainage.Vestnik Khirugii. 1987;4:42–45.

5. Davydov YA, Larichev AB, Men’kov KG. Bacteriologic andcytologic assessment of vacuum therapy of purulentwounds. Vestnik Khirurgii. 1988;141:48–52.

6. Davydov YA, Larichev AB, Abramov AY, Menkov KG.Concepts for clinical biological management of thewound process in the treatment of purulent wounds

Gupta et al

8 WOUNDS A Compendium of Clinical Research and Practice

Wound Type

Chronic (diabeticlower extremity)

Acute (traumatic)

Subacute anddehisced Partial-thicknessburns

Pressure ulcers

Flaps and grafts

Case Number

3, 5

1, 2

4

6

7

1

NPWT Modality

Versatile 1

V.A.C. Therapy

Versatile 1

Versatile 1

Versatile 1

V.A.C. Therapy

Outcome

Stalled healing; seconddebridement and V.A.C. forsalvageSuccessful tertiary closureand flap closureInfection; abscess drainageand V.A.C. for salvageIncreased necrotic tissue;debridement and V.A.C. forsalvageInfection; urgent operativedebridement and V.A.C. forsalvageSuccessful flap andcomplete graft take

Indication-SpecificEvidence Supporting

NPWTReferences 15, 16,25, 26, 30

References 19, 30,34References 18, 28,29, 30, 33References 30, 32

References 17, 30,31

References 30, 32

Table 3. Case series summarized by indications

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using vacuum therapy. Vestnik Khirurgii.1991;146:132–135.

7. Fleischmann W,Becker U,Bishoff M et al.Vacuum sealing:indication, technique and results. Eur J Ortho Surg andTrauma. 1995;5:37–40.

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9. Chariker ME, Jeter KF,Tintle TE. Effective management ofincisional and cutaneous fistulae with closed suctionwound drainage. Contemporary Surg. 1989;(34):59–63.

10. Morykwas MJ,Argenta LC, Shelton-Brown EI, McGuirt W.Vacuum-assisted closure: a new method for wound con-trol and treatment: animal studies and basic foundation.Ann Plast Surg. 1997; 38(6):553–562.

11. Kinetic Concepts Inc. V.A.C.® Therapy™ ClinicalGuidelines. A Reference Source for Clinicians. SanAntonio,Tex: Kinetic Concepts Inc; 2005.

12. BlueSky Medical. Versatile 1 Clinical Protocol andGuidelines. Carlsbad, Calif: BlueSky Medical; 2006.

13. Saxena V, Hwang CW, Huang S, Eichbaum Q, Ingber D,Orgill DP.Vacuum-assisted closure: microdeformations ofwounds and cell proliferation. Plast Reconstr Surg.2004;114(5):1086–1096.

14. BlueSky Medical. Versatile 1 Wound Vacuum SystemInstructions for Use and System Product Brochure.Available at: http://www.blueskymedical.com. AccessedDecember 15, 2006.

15. Sibbald RG, Mahoney J; V.A.C. Therapy CanadianConsensus Group.A consensus report on the use of vac-uum-assisted closure in chronic, difficult-to-heal wounds.Ostomy Wound Manage. 2003;49(11):52–66.

16. Armstrong DG, Attinger CE, Boulton AJ, et al. Guidelinesregarding negative pressure wound therapy (NPWT) inthe diabetic foot. Ostomy Wound Manage. 2004;50(4BSuppl):3S–27S.

17. Gupta S, Baharestani M, Baranoski S, et al. Guidelines formanaging pressure ulcers with negative pressure woundtherapy. Adv Skin Wound Care. 2004;17(Suppl 2):1–15.

18. Orgill DP,Austen WG, Butler CE, et al. Guidelines for treat-ment of complex chest wounds with negative pressuretherapy. WOUNDS. 2004;16(12 Suppl B):1–23.

19. Kaplan M, Banwell P, Orgill D, et al. Guidelines for themanagement of the open abdomen. WOUNDS.2005;17(10 Suppl):1–24.

20. Miller MS, Brown R.APWCA case #3: using negative pres-sure for wound therapy. Podiatry Manage.2005;June/July:121–126.

21. Miller MS, Brown R, McDaniel C. Negative pressurewound therapy options promote patient care.BioMechanics. September 2005. Available at:http://www.biomechanics.com. Accessed December 1,2006.

22. Miller MS,Lowery CA.Negative pressure wound therapy:“a rose by any other name.” Ostomy Wound Manage.2005;51(3):44–49.

23. Miller MS,Whinney R, McDaniel C.Treating a nonhealingwound with negative pressure wound therapy. Adv Skin

Wound Care. 2006;19(4):202–205.24. Campbell PE. Surgical wound case studies with the

Versatile 1 Wound Vacuum System for negative pressurewound therapy. J Wound Ostomy Continence Nurs.2006;33(2):176–190.

25. Armstrong DG, Lavery LA; Diabetic Foot StudyConsortium. Negative pressure wound therapy after par-tial diabetic foot amputation: a multicentre, randomisedcontrolled study. Lancet. 2005;366(9498):1704–1710.

26. Vuerstaek JD,Vainas T,Wuite J,Nelemans P,Neumann MH,Veraart JC. State-of-the-art treatment of chronic legulcers: a randomized controlled trial comparing vacuum-assisted closure (V.A.C.) with modern wound dressings. JVasc Surg. 2006;44(5):1029–1037.

27. Venturi ML,Attinger CE, Mesbahi AN, Hess CL, Graw KS.Mechanisms and clinical applications of the vacuum-assisted closure (VAC) device: a review. Am J ClinDermatol. 2005;6(3):185–194.

28. Sjogren J, Gustafsson R, Nilsson J, Malmsjo M,Ingemansson R. Clinical outcome after posternotomymediastinitis:vacuum-assisted closure versus convention-al treatment. Ann Thorac Surg. 2005;79(6):2049–2055.

29. Demaria R, Giovannini UM, Teot L, Frapier JM, Albat B.Topical negative pressure therapy. A very useful newmethod to treat severe infected vascular approaches inthe groin. J Cardiovasc Surg (Torino).2003;44(6):757–761.

30. de Lange MY, Schasfoort RA, Obdeijn MC, van der WerffJFA, Nicolai JPA.Vacuum-assisted closure: indications andclinical experience. Eur J Plast Surg.2000;23(4):178–182.

31. Greer SE, Duthie E, Cartolano B, Koehler KM, Maydick-Youngberg D, Longaker MT.Techniques for applying sub-atmospheric pressure dressing to wounds in difficultregions of anatomy. J Wound Ostomy Continence Nurs.1999;26(5):250–253.

32. Scherer L, Shiver S,Chang M,Meredith JW,Owings JT.Thevacuum assisted closure device: a method of securingskin grafts and improving graft survival. Arch Surg.2002;137(8):930–933.

33. Agarwal JP, Ogilvie M, Wu LC, et al. Vacuum-assisted clo-sure for sternal wounds: a first-line therapeutic manage-ment approach. Plast Reconstr Surg.2005;116(4):1035–1040.

34. Meara JG, Guo L, Smith JD, Pribaz JJ, Breuing KH, OrgillDP.Vacuum-assisted closure in the treatment of deglovinginjuries. Ann Plast Surg. 1999;42(6):589–594.

35. Moues CM, van den Bemd GJ, Meerding WJ, Hovius SE.Aneconomic evaluation of the use of TNP on full-thicknesswounds. J Wound Care. 2005;14(5):224–227.

36. Sheehan P. Early change in wound area as a predictor ofhealing in diabetic foot ulcers: knowing “when to saywhen.” Plast Reconstr Surg. 2006;117(7Suppl):245S–247S.

37. Jones S,Bowler PG,Walker M.Antimicrobial activity of sil-ver-containing dressings is influenced by dressing con-formability with a wound surface. WOUNDS.2005;17(9):263–270.

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