This document addresses the use of vacuum assisted wound therapy (also known as negative pressure wound therapy or NPWT) in the outpatient setting for a variety of wounds (i.e., ulcers related to pressure sores, venous or arterial insufficiency or neuropathy).  There are two device types available on the market which deliver vacuum assisted wound therapy.  The first is an "electrically powered" device that uses electricity to operate a suction pump to create a vacuum.  The second is a "non-electrically powered" pump that uses a mechanical (i.e., spring loaded) device to create a vacuum.

Note: For other documents that address wound healing and management; please see:

• CG-DME-16 Pressure Reducing Support Surfaces; Groups 1, 2, & 3
• MED.00046 Electrical Stimulation and Electromagnetic Therapy for Wound Healing
• MED.00096 Low-Frequency Ultrasound Therapy for Wound Management
• SURG.00011 Autologous, Allogeneic, Xenographic, Synthetic and Composite Products for Wound Healing and Soft Tissue Grafting

NOTE: In some circumstances, the use of this treatment modality when initiated in the inpatient setting may not meet criteria for use in the outpatient setting.

Medically Necessary:

Electrically powered vacuum assisted wound therapy is considered medically necessary when the individual meets the following criteria categorized according to: 1) Participation in a complete wound care program; AND 2) Presence of an eligible condition; AND 3) Absence of contraindications to vacuum assisted wound therapy: AND 4) Individual is 13 years of age or older: 

1. Participation in a complete wound care program:
   A complete wound care program has been tried or considered and ruled out prior to the addition of vacuum assisted wound therapy to the overall management of wounds in ALL individuals in ALL settings.  Such a wound care program should include ALL of the following:
   • Documentation in the individual's medical record of evaluation, care, and wound measurements by a licensed medical professional; and
   • Application of dressings to maintain a moist environment; and
   • Debridement of necrotic tissue if present; and
   • Evaluation of and provision for adequate nutritional status; and
   • All underlying medical conditions have been stabilized or are under current management (i.e., diabetes, venous insufficiency).
2. Eligible condition (individual must meet ONE of the following bullets): 
   • Stage III or IV pressure ulcers (see key terms below) at initiation of vacuum assisted wound therapy, in individuals who meet ALL of the following:
     1. The individual has been appropriately turned and positioned; and
     2. The individual has used a group 2 or 3 support surface for pressure ulcers on the posterior trunk or pelvis (no special support surface is required for ulcers not located on the trunk or pelvis); and
     3. The individual's moisture and incontinence have been appropriately managed; or
   • Neuropathic ulcers in individuals who meet BOTH of the following:
     1. The individual has been on a comprehensive diabetic management program; and
     2. Reduction in pressure on a foot ulcer has been accomplished with appropriate modalities; or
   • Ulcers related to venous or arterial insufficiency, in individuals who meet ALL of the following:
     1. Compression bandages and/or garments have been consistently applied; and
     2. Reduction in pressure on a foot ulcer has been accomplished with appropriate modalities; and
     3. For initiation of therapy in the home setting, presence of the ulcer for at least 30 days; or
   • Dehisced wounds or wound with exposed hardware or bone; or
   • Post sternotomy wound infection or mediastinitis; or
   • Complications of a surgically created wound where accelerated granulation therapy is necessary and cannot be achieved by other available topical wound treatment.

The following are absolute contraindications to vacuum assisted wound therapy:

• necrotic tissue with eschar present; or
• untreated osteomyelitis; or
• non-enteric and unexplored fistulas; or
• malignancy in the wound; or
• exposed vasculature; an or d
• exposed nerves; or
• exposed anastomotic site; or
• exposed organs.

Investigational and Not Medically Necessary 

Electrically powered vacuum assisted wound therapy is considered investigational and not medically necessary when ANY of the following criteria is present:

• Documentation of weekly assessment of the wound's dimensions and characteristics by a licensed health care professional indicates absence of adequate progress; or
• Failure of progressive wound healing without intervening complications; or
• In the judgment of the treating physician, adequate wound healing has occurred to the degree that vacuum assisted wound therapy may be discontinued; or
• Other applications of vacuum assisted wound therapy not meeting the medical necessity criteria above.

Non-electrically powered vacuum assisted wound therapy (e.g., SNaP™ Wound Care Device) is considered investigational and not medically necessary for all conditions.

Because of the multimodality nature of wound care, ideally randomized trials are required to isolate the contribution of any one component.  Additionally, trials should include clinically relevant endpoints, such as the percent of individuals with complete healing or the percent of individuals that require skin grafting, and stratify results according to wound type and size.  There have been no published randomized trials (RCTs) that meet these criteria.  Several small randomized trials of negative pressure wound therapy (NPWT) using electrically powered devices have been published, all of which reported positive results according to some parameter of wound healing (Armstrong, 2005; Canaino, 2005; De Franzo, 2001; Doss, 2002; Eginton, 2003; Blume, 2008; Stannard, 2009).  There are methodological flaws with all of these articles.  However, many case series have reported positive results (Baillot, 2009; Ford, 2002; Garner, 2001; Hersh, 2001; Moisidis, 2004; Moues, 2004; O'Connor, 2005), and vacuum assisted wound therapy has been widely accepted and implemented in the medical community on a national basis.

On February 24, 2011 the U.S. FDA released an updated Safety Communication, following up on a previous notice regarding major complications related to the use of NPWT systems.  This update adds further information addressing the use of NPWT systems in the treatment of infants and children.  The communication specifically states: "The safety and effectiveness of NPWT systems in newborns, infants and children has not been established at this time and currently, there are no NPWT systems cleared for use in these populations."   In light of this information, the use of such devices should be limited to non-child populations.  The FDA defines a "child" as greater than 2 to 12 years of age (U.S. FDA Premarket Assessment of Pediatric Medical Devices, 2004).

A non-electrically powered vacuum assisted wound therapy device (SNaP™ Wound Care Device) has been FDA approved for market.  This device utilizes specialized springs to create the vacuum needed for negative pressure wound therapy.  At this time, the available data addressing this type of non-electrically powered vacuum assisted wound therapy is limited.  One small study was a retrospective case-control study with 36 subjects in the "non-electrically powered" vacuum treated group compared to a group of 42 subjects who received a variety of other wound therapies (Lerman, 2010).  A high drop-out rate was observed with only 21 of the 36 individuals enrolled in the experimental group completing the study.  All subjects had either neuropathic or venous stasis ulcers.  The authors reported a significantly better improvement in wound size, healing progression, and healing time in the non-electrically powered vacuum assisted wound therapy group compared to the control subjects.  This study lacked both randomization of the treatment groups and blinding.  A second study was a small cases series of 12 subjects with neuropathic or venous stasis ulcers (Fong, 2010).  Only 6 of 12 (50%) completed the study.  However, complete healing at 4 weeks in 5 of these 6 subjects was reported.  The small sample size, lack of control group, and significant loss to follow-up all hinder the generalizability of these results.

In March 2011 Armstrong and others published the interim results of a small RCT suggesting non-inferiority to standard powered NPWT.  This report included only 33 patients completing the study to date (n= 18 SNAP and 15 standard powered VAC).   In addition to its small size, there are other concerns with this data, including significant differences between the two groups in terms of wound size and age prior to treatment.  Initial wound size in the standard VAC group was 8.8 sq cm  and  4.3 sq cm in the SNAP group.  Age of wound was 14 months in the VAC group and 8.3 months in the SNAP group.  This study is described as on-going in Clinical Trials.gov with plans for 64 enrollees and a completion date targeted for December 2011. 

On November 13, 2009, the U.S. Food and Drug Administration released a Medical Device Alert regarding the use of negative pressure wound therapy systems.  This alert was intended to notify medical practitioners of possible death or serious complications due to the use of vacuum assisted wound therapy systems.  The FDA stated that it had received reports of six deaths and 77 injuries associated with NPWT systems over the past two years.  Major complications reported include bleeding and infection.  The warning provides recommendations to reduce the risk of NPWT including:

• More careful selection of patients for vacuum assisted wound therapy
• Assure that the patient is monitored frequently in an appropriate care setting by a trained practitioner. In determining the frequency of monitoring, consider the patient's condition, including the wound status, wound location and co-morbidities
• Obtain appropriate training prior to prescribing and using NPWT
• Instructions for proper home use of vacuum assisted wound therapy systems

In addition, the FDA stated that vacuum assisted wound therapy is contraindicated for wounds with:

• necrotic tissue with eschar present
• untreated osteomyelitis
• non-enteric and unexplored fistulas
• malignancy (within the wound)
• exposed blood vessels, nerves, anastomoses, or organs 

For the full text of the warning, please see: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm190658.htm.

The management and treatment of chronic wounds, including pressure ulcers, remain a challenge.  Most chronic wounds will heal only if the underlying cause, i.e., venous stasis, pressure, infection, etc, is addressed.  In addition, cleaning the wound to remove non-viable tissue, microorganisms and foreign bodies is essential to create the optimal conditions for either re-epithelialization or preparation for wound closure with skin grafts or flaps.  Therefore, debridement, irrigation, whirlpool treatments and wet to dry dressings are common components of chronic wound care.

Vacuum assisted wound therapy is used as adjunct to the basic principles of wound care described above.  This technique involves applying initial continuous and subsequent intermittent topical negative pressure to an entire wound.  The action removes excess fluid from the interstitial space of the wound, enhancing vascular perfusion through vessels compressed by the excess fluid pressure.  Additionally, it is believed that removal of excess fluid removes an accumulation of healing-inhibitory factors.  Finally, mechanical stretching results in deformation of cellular bridges, which increases cellular proliferation, protein synthesis, and granulation tissue.  The net result is accelerated wound closure by re-epithelialization or preparation for wound closure with suturing, skin grafts or flaps (delayed primary intention).

There are currently two classifications of vacuum assisted wound therapy devices available on the market.  The first is an "electrically powered" device that creates vacuum via an electrically operated pump.  The electricity may come from either a wall outlet or battery power.  The second, referred to as a "non-electrically powered" pump, creates vacuum through the operation of a mechanical (i.e., spring loaded) device.  The majority of available devices are of the "electrically powered" type.

Dehisced wounds: A condition where a wound has a premature opening or splitting along natural or surgical suture lines due to improper healing. 

Eschar: A dry scab that forms on skin that has been burned or exposed to corrosive agents.

Group 2 or 3 support surfaces: Two groups within the three classifications of specialized pressure reducing bed types available as a preventive measure for bedsores.  The classification system is as follows:

Group 1 -   Pressure reducing mattress overlays.  These overlays may be filled with air, water, foam or gel and are intended for placement over a standard mattress

Group 2 -   Special mattresses alone or fully integrated into a bed.  These mattresses may be filled with air, water, foam or gel and are intended as a replacement for a standard mattress

Group 3 -   Air Fluidized Beds.  These are devices that employ the circulation of filtered air through silicone coated ceramic beads that create the characteristics of fluid, creating a sensation of floating 

Mediastinitis:  A condition characterized by inflammation of the cavity that holds the heart and other organs. 

Neuropathic ulcer: An ulcer resulting from the loss of sensation (i.e., pain, touch, stretch) as well as protective reflexes, due to loss of nerve supply to a body part.

Post-sternotomy: The period of time immediately following any surgery where the sternum or breastbone is opened to gain access to the chest cavity.

Pressure ulcer (National Pressure Ulcer Advisory Panel, 2007):  A pressure ulcer is localized injury to the skin and/or underlying tissue usually over a bony prominence, as a result of pressure, or pressure in combination with shear and/or friction. A number of contributing or confounding factors are also associated with pressure ulcers. The significance of these factors is yet to be elucidated.

Pressure ulcer stages:

Suspected deep tissue injury:
Purple or maroon localized area of discolored intact skin or blood-filled blister due to damage of underlying soft tissue from pressure and/or shear.  Tthe area may be preceded by tissue that is painful, firm, mushy, boggy, warmer or cooler as compared to adjacent tissue.
Further description:
Deep tissue injury may be difficult to detect in individuals with dark skin tones.  Evolution may include a thin blister over a dark wound bed.  The wound may further evolve and become covered by thin eschar  Evolution may be rapid exposing additional layers of tissue even with optimal treatment.

Stage I:
Intact skin with non-blanchable redness of a localized area usually over a bony prominence.  Darkly pigmented skin may not have visible blanching.  Its color may differ from the surrounding area.
Further description:
The area may be painful, firm, soft, warmer or cooler as compared to adjacent tissue.  Stage I may be difficult to detect in individuals with dark skin tones.  May indicate "at risk" persons (a heralding sign of risk).

Stage II:
Partial thickness loss of dermis presenting as a shallow open ulcer with a red pink wound bed, without slough.  May also present as an intact or open/ruptured serum-filled blister.
Further description:
Presents as a shiny or dry shallow ulcer without slough or bruising;* this stage should not be used to describe skin tears, tape burns, perineal dermatitis, maceration or excoriation.
*Bruising indicates suspected deep tissue injury.

Stage III:
Full thickness tissue loss.  Subcutaneous fat may be visible but bone, tendon or muscle are not exposed.  Slough may be present but does not obscure the depth of tissue loss.  May include undermining and tunneling.
Further description:
The depth of a stage III pressure ulcer varies by anatomical location. The bridge of the nose, ear, occiput and malleolus do not have subcutaneous tissue and stage III ulcers can be shallow. In contrast, areas of significant adiposity can develop extremely deep stage III pressure ulcers.  Bone/tendon is not visible or directly palpable.

Stage IV:
Full thickness tissue loss with exposed bone, tendon or muscle.  Slough or eschar may be present on some parts of the wound bed. Often include undermining and tunneling.
Further description:
The depth of a stage IV pressure ulcer varies by anatomical location.  The bridge of the nose, ear, occiput and malleolus do not have subcutaneous tissue and these ulcers can be shallow. Stage IV ulcers can extend into muscle and/or supporting structures (e.g., fascia, tendon or joint capsule) making osteomyelitis possible. Exposed bone/tendon is visible or directly palpable. 

Unstageable:
Full thickness tissue loss in which the base of the ulcer is covered by slough (yellow, tan, gray, green or brown) and/or eschar (tan, brown or black) in the wound bed.
Further description:
Until enough slough and/or eschar is removed to expose the base of the wound, the true depth, and therefore stage, cannot be determined. Stable (dry, adherent, intact without erythema or fluctuance) eschar on the heels serves as "the body's natural (biological) cover" and should not be removed.

Vacuum assisted wound therapy: A type of medical therapy that involves the use of suction (negative pressure) underneath airtight wound dressings to promote the healing of open wounds that have resisted previous treatments. There are two device types available on the market which deliver vacuum assisted wound therapy.  The first is an "electrically powered" device that uses electricity to operate a suction pump to create a vacuum.  The second is a "non-electrically powered" pump that uses a mechanical (i.e., spring loaded) device to create a vacuum.

The following codes for treatments and procedures applicable to this document are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary, when criteria are met:

When services are Investigational and Not Medically Necessary:
For the procedure codes listed above, when criteria are not met; or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

When services are also Investigational and Not Medically Necessary:
When the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Peer Reviewed Publications:

1. Armstrong DG, Lavery LA. Diabetic Foot Study Consortium. Negative pressure wound therapy after partial diabetic foot amputation: a multicentre, randomised controlled trial. Lancet. 2005; 366(9498):1704-1710.
2. Armstrong DG, Marston WA, Reyzelman AM, Kirsner RS. Comparison of negative pressure wound therapy with an ultraportable mechanically powered device vs. traditional electrically powered device for the treatment of chronic lower extremity ulcers: a multicenter randomized-controlled trial. Wound Repair Regen. 2011; 19(2):173-180.
3. Baillot R, Cloutier D, Montalin L, et al. Impact of deep sternal wound infection management with vacuum-assisted closure therapy followed by sternal osteosynthesis: a 15-year review of 23,499 sternotomies. Eur J Cardiothorac Surg. 2010; 37(4):880-887.
4. Blume P, Walters J, Payne W. Comparison of negative pressure wound therapy using vacuum-assisted closure with advanced moist wound therapy in the treatment of diabetic foot ulcers: a multicenter randomized controlled trial. Diabetes Care 2008; 31(4):631-636.
5. Caniano DA, Ruth B, Teich S.  Wound management with vacuum-assisted closure: experience in 51 patients.  J Pediatr Surg. 2005; 40(1):128-152.
6. De Franzo AJ, Argenta LC, Marks MW, et al.  The use of vacuum-assisted closure therapy for the treatment of lower extremity wounds with exposed bone.  Plast Reconstr Surg. 2001; 108(5):1184-1191.
7. Doss M, Martens S, Wood JP, et al.  Vacuum assisted suction drainage versus conventional treatment in the management of poststernotomy osteomyelitis.  Eur J Cardiothorac Surg. 2002; 22(6):934-938.
8. Eginton MT, Brown KR, Seabrook GR, et al.  A prospective randomized evaluation of negative pressure wound dressings for diabetic foot wounds.  Ann Vasc Surg. 2003; 17(6):645-649.   
9. Fong KD, Hu D, Eichstadt SL, et al. Initial clinical experience using a novel ultraportable negative pressure wound therapy device. Wounds. 2010; 22(9):230–236.
10. Ford CN, Reinhard ER, Yeh D.  Interim analysis of a prospective, randomized trial of vacuum-assisted closure versus the Healthpoint system in the management of pressure ulcers.  Ann Plast Surg. 2002; 49(1):55-61.
11. Garner GB, Ware DN, Cocanour CS, et al.  Vacuum-assisted wound closure provides early fascial reapproximation in trauma patients with open abdomens.  Am J Surg. 2001; 182(6):630-638.
12. Hersh RE, Jack JM, Dahman MI, et al. The vacuum-assisted closure device as a bridge to sternal wound closure.  Ann Plast Surg. 2001; 46(3):250-254.
13. Lerman B, Oldenbrook L, Eichstadt SL, et al. Evaluation of chronic wound treatment with the SNaP wound care system versus modern dressing protocols. Plast Reconstr Surg. 2010; 126(4):1253-1261.
14. Llanos S, Danilla S, Barraza C, et al. Effectiveness of negative pressure closure in the integration of split thickness skin grafts: a randomized, double-masked, controlled trial. Ann Surg. 2006; 244(5):700-705. 
15. Moisidis E, Heath T, Boorer C, et al.  A prospective, blinded, randomized, controlled clinical trial of topical negative pressure use in skin grafting.  Plast Reconstr Surg. 2004; 114(4):917-922.
16. Moues CM, Vos MC, van den Bemd GJ, et al.  Bacterial load in relation to vacuum-assisted closure wound therapy: a prospective randomized trial.  Wound Repair Regen. 2004; 12(1):11-17.
17. O'Connor J, Kells A, Henry S, Scalea T.  Vacuum-assisted closure for the treatment of complex chest wounds.  Ann Thorac Surg. 2005; 79(4):1196-200.
18. Saaiq M, Hameed-Ud-Din, Khan MI, Chaudhery SM. Vacuum-assisted closure therapy as a pretreatment for split thickness skin grafts. J Coll Physicians Surg Pak. 2010; 20(10):675-679.
19. Stannard JP, Volgas DA, Stewart R, et al. Negative pressure wound therapy after severe open fractures: a prospective randomized study. J Orthop Trauma. 2009; 23(8):552-557.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Agency for Healthcare Research and Quality. Technology assessment: Negative Pressure Wound Therapy Devices.  May 26, 2009. Available at: http://www.ahrq.gov/clinic/ta/negpresswtd/. Accessed on May 12, 2011.
2. National Pressure Ulcer Advisory Panel. Pressure Ulcer Stages Revised by NPUAP. Available at: http://www.npuap.org/pr2.htm.  Accessed on December 20, 2010.
3. Ubbink DT, Westerbos SJ, Evans D, et al. Topical negative pressure for treating chronic wounds. Cochrane Database Syst Rev. 2008;(3):CD001898
4. U.S. FDA Premarket Assessment of Pediatric Medical Devices. May 24, 2004. Available at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089740.htm#3a. Accessed on May 19, 2011.
5. U.S. FDA Safety Communication: UPDATE on Serious Complications Associated with Negative Pressure Wound Therapy Systems. February 24, 2011. Available at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm244211.htm.  Accessed on May 19, 2011.
6. U.S. FDA Safety Communication: Serious Complications Associated with Negative Pressure Wound Therapy Systems. November 13, 2009. Available at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm190658.htm. Accessed on May 12, 2011.
7. Wasiak J, Cleland H. Topical negative pressure (TNP) for partial thickness burns. Cochrane Database Syst Rev. 2007. 18;(3):CD006215.

ActiV.A.C.^® Therapy Unit
Chariker-Jeter Wound Sealing Kit
Engenex^® Advanced NPWT System
Exusdex^® wound drainage pump
EZCARE Negative Pressure Wound Therapy
InfoV.A.C. ^® Therapy Unit
Invia Liberty Wound Therapy
Invia Vario 18 c/i Wound Therapy
Mini V.A.C. ^®
Neo-Gen One
NPD 1000 Negative Pressure Wound Therapy System
Prodigy™ NPWT System (PMS-800 and PMS-800V)
PRO-I™
PRO-II™
PRO-III™
RENASYS EZ™
RENASYS GO™
SNaP™ Wound Care Device
SVEDMAN™ and
SVED™ Wound Treatment Systems
V.A.C.™
VAWC Device
Vacuum Assisted Wound Closure System
Venturi™ Negative Pressure Wound Therapy
Versatile 1™
V1STA Negative Pressure Wound Therapy

The use of specific product names is illustrative only.  It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.