Consumer Reports: NPWT Manufacturer

The companies listed in this section agreed to provide TWC information on their NPWT products.

Medela, Inc. • McHenry, IL • www.medela.com • (877) 694-6842

1) How many different NPWT products does your company currently produce? There are two negative pressure wound therapy pumps available. They are Invia Liberty and Invia Vario. The Invia Liberty provides advanced negative pressure for the mobile patient. The Invia Vario provides basic negative pressure for the non-ambulatory patient.

2) Please name all of your NPWT related products?
For the Invia Liberty:
  • Liberty Canisters 800ml and 300ml with solidifier
  • Liberty Double Lumen tubing
  • For Invia Vario
  • Vario Tubing
  • Vario Canister 800ml and 1200ml

All Invia pumps
  • Invia Wound Dressing Sets include the drain of choice with the following choices in components transparent dressing, non-adherent wound contact layer, antimicrobial Kerlix™ gauze, Cavilon™ no sting barrier wipe, Hy•Tape adhesive tape, sterile saline, and Coloplast® stoma paste. Call Medela Customer Service for details at (877) 735-1626.

3) What is the suction pressure of your machine or the range of pressures that the machine achieves?
The negative pressure recommended for Invia Wound Therapy systems are between -60mmHg to -80mmHg but the pumps have the following negative pressure ranges:
  • Invia Liberty’s range of negative pressure is -60mmHg to -200mmHg.
  • Invia Vario’s range of negative pressure is 0mmHg to -400mmHg.

4) Is the pressure pre-set?
  • Invia Liberty is pre-set at 60mmHg.
  • Invia Vario does not have a pre-set setting.

5) Can it be changed? Yes, the pressure can be changed on both pumps.

6) Is there an intermittent feature? Yes, there is an intermittent feature on both Liberty and Vario.

7) Is there a cut off which stops suction if the canister is full? Invia Liberty will alarm to alert the caregiver when the canister is full, therapy will continue if canister is changed in a timely manner. The Invia Vario will shut off suction when canister is full.

8) Is there a one-way valve to prevent fluid from coming back through the tubing towards the patient? Yes, Liberty has a one-way valve to prevent fluid from going back through the tubing towards the patient.

9) How long does the battery last?
  • Invia Liberty battery last up to 14 hours.
  • Invia Vario battery last up to 1 hour.

10) How much does the machine weigh? (How portable is it?)
  • Invia Liberty weighs 2.2lbs.
  • Invia Vario weighs 11.2 lbs.

11) What is the interface with the wound? The Invia Wound Therapy negative pressure system utilizes a non-adherent contact layer as a primary dressing and antimicrobial gauze as wound filler.

12) How often do you recommend changing the dressing? Dressing changes are recommended 2 to 3 times weekly.

13) Can you "y" wounds together and if so how many? Two to three wounds may be Y connected as needed.

14) How do you handle undermining? As part of the Invia Wound Therapy system, several drain options are available to address different characteristics of wounds. The drains recommended for undermining are 10 FR perforated round and 15 FR channel.

15) How do you handle fistulas? Invia Wound Therapy is contraindicated for non-enteric and unexplored fistulas. Invia Wound Therapy may be used with precaution in explored and enteric fistula.

16) How do you handle exposed tendon or bone? Invia Wound Therapy may be used with precaution over exposed tendon or bone.

17) Do you have any special recommendations for high bioburden or infection? Invia Wound Therapy is contraindicated in untreated osteomyelitis. For infected wounds, we recommend that a more frequent dressing change be considered.

18) How is your device billed? (Is the machine rented and how are supplies obtained?) The Invia Wound Therapy system is PDAC coded for reimbursement. The Invia Wound Therapy pumps are billed under code E2402, the canisters under code A7000, and the kits under A6550. The pumps may be purchased or rented. The wound dressing sets and disposables (canisters and tubing) can be purchased from Medela or through our distribution network.

Ohio Medical Corporation, Gurnee, IL • www.MoblVacNPWT.com • (800) 668-2337

1) How many different NPWT products does your company currently produce? 1 Pump and multiple accessories and kits.

2) Please name all of your NPWT related products? MoblVac® Portable Wound Care Pump and TruSealTM Link Wound Care Kits.

3) What is the suction pressure of your machine or the range of pressures that the machine achieves?
  • Flow rate is 10L/min.
  • Pressure range 25-200 mmHg.

4) Is the pressure pre-set? No.

5) Can it be changed? Yes.

6) Is there an intermittent feature? Yes.

7) Is there a cut off which stops suction if the canister is full? Yes.

8) Is there a one-way valve to prevent fluid from coming back through the tubing towards the patient? No.

9) How long does the battery last? 24 hours.

10) How much does the machine weigh? (How portable is it?) 4 lbs (portable with available carrying case).

11) What is the interface with the wound? Antimicrobial Gauze.

12) How often do you recommend changing the dressing? Every 72 hours or facility’s protocol.

13) Can you "y" wounds together and if so how many? Yes, two with each Y connector.

14) How do you handle undermining? Clinical treatment should be determined by the attending physician and hospital protocol.

15) How do you handle fistulas? Clinical treatment should be determined by the attending physician and hospital protocol.

16) How do you handle exposed tendon or bone? Clinical treatment should be determined by the attending physician and hospital protocol.

17) Do you have any special recommendations for high bioburden or infection? Clinical treatment should be determined by the attending physician and hospital protocol.

18) How is your device billed? (Is the machine rented and how are supplies obtained?) Rental or purchase. Pump and supplies available thru Invacare Continuing Care at (800) 668-2337.

Innovative Therapies, Inc. •Gaithersburg, MD • www.itinpwt.com • 866-ITI-NPWT (484-6798)

1) How many different NPWT products does your company currently produce? Two NPWT units, black and white foam dressings, and accessories.

2) Please name all of your NPWT related products? NPWT Unit: SVED and Svedman. See Table on page 18 for complete information.

3) What is the suction pressure of your machine or the range of pressures that the machine achieves? Our one-touch NPWT therapy unit is designed to provide three pressure choices: -70 mmHg, -120 mmHg, and -150 mmHg.

4) Is the pressure pre-set? The default pressure setting is -120 mmHg.

5) Can it be changed? Yes, it can be changed with the touch of a button. ITI is the first company to introduce a “One Touch” operation of its NPWT units.

6) Is there an intermittent feature? Yes. The ITI intermittent feature provides the set pressure for 5 minutes, and then decreases to -25 mmHg for two minutes. The rationale for not going all the way to zero is to prevent the dressing from becoming dislodged and leaking when the seal is lost during the off cycle.

7) Is there a cut off which stops suction if the canister is full? Yes, the canister has a device to prevent fluid egress when the canister is full.

8) Is there a one-way valve to prevent fluid from coming back through the tubing towards the patient? The canister acts as a fluid trap. Once fluid enters, it is prevented from leaving the canister. In addition a gelling agent is used to convert the fluid to a semi-solid state and help prevent inadvertent spills.

9) How long does the battery last? Up to 18 hours, but this depends on the pressure setting and the dressing seal.

10) How much does the machine weigh? (How portable is it?) The SVED weighs less than two pounds. It comes with a shoulder bag for portability. The larger Svedman weighs less than 5.5 pounds.

11) What is the interface with the wound? Two types of foam choices are used as wound interfaces: a black hydrophobic foam, and a white hydrophilic foam.

12) How often do you recommend changing the dressing? Routine dressing changes should occur every 48 to 72 hours. Dressing changes for infected wounds should be done more frequently than 48-72 hours.

13) Can you "y" wounds together and if so how many? You can Y multiple wounds together. Use of the “Y” connector must be determined on a case-by-case basis and is dependent on size and depth of the multiple wound sites. Multiple wounds may be connected together with a foam bridge. Multiple therapy units can be used with a patient as well.

14) How do you handle undermining? Because of the high tensile strength of the ITI black foam, undermining may be filled in with black foam. For deeper undermining we suggest that the clinician wrap the black foam with a wound contact layer to prevent it from sticking inside the undermining.

15) How do you handle fistulas? ITI suggests the clinician consider using irrigation to keep the effluent thin so that foam does not become occluded. Also, if appropriate, the pressure may be increased to -150 mmHg.

16) How do you handle exposed tendon or bone? ITI recommends that these structures be covered with our white foam to encourage granulation.

17) Do you have any special recommendations for high bioburden or infection? Simultaneous between ITI and irrigation it provides continuous or intermittent irrigation in conjunction with negative pressure suction. Any irrigant indicated for topical wound treatment may be used, including antimicrobials and antibiofilm agents. In addition, a silver wound contact layer may be used underneath the foam if a topical antimicrobial is desired.

18) How is your device billed? (Is the machine rented and how are supplies obtained?) The device may be rented or purchased, and the disposables are purchased.

Kalypto Medical •Mendota Heights, MN • www.kalyptomedical.com • 877-286-3740

1) How many different NPWT products does your company currently produce? We currently have one, a truly portable negative pressure pump device with three compatible dressing configurations.

2) Please name all of your NPWT related products? NPD 1000 Negative Pressure Wound Therapy Pump, 50 cc (8 cm x 12 cm), 50 cc Forefoot dressing (11 in x 16 in), 140 cc rectangular dressing (12 cm x 16 cm).

3) What is the suction pressure of your machine or the range of pressures that the machine achieves? The NPD 1000 NPWT system has a pressure range of -40 mmHg to -125 mmHg.

4) Is the pressure pre-set? The default setting is -125 mmHg.

5) Can it be changed? Yes, it is adjustable.

6) Is there an intermittent feature? The system features an intermittent setting with 5 minutes at negative pressure and 2 minutes at ambient pressure.

7) Is there a cut off which stops suction if the canister is full? The system is canister less, with the exudates absorbed in the dressing by a proprietary super-absorbent non-woven.

8) Is there a one-way valve to prevent fluid from coming back through the tubing towards the patient? The fluid never leaves the dressing and is prevented from doing so by a Gore-Tex membrane.

9) How long does the battery last? The batteries (3 AA alkaline) will last 3 to 6 weeks under normal operating conditions.

10) How much does the machine weigh? (How portable is it?) With batteries, the device weighs 8 oz.

11) What is the interface with the wound? The wound interface is Silverlon, an FDA cleared minimally adherent anti-microbial wound contact layer.

12) How often do you recommend changing the dressing? This is a clinician decision, but we are seeing 2-3 times a week as standard of care.

13) Can you "y" wounds together and if so how many? We have a Y-connector available. It will tie two wounds together. The device has not been tested for more than two dressings.

14) How do you handle undermining? Packing and undermining are a clinical decision. As a manufacturer, we are unable to make a recommendation.

15) How do you handle fistulas? Fistulas are best treated by other NPWT systems.

16) How do you handle exposed tendon or bone? Protection of exposed tendon and bone is the responsibility of the caregiver. However, our wound interface, unlike those of other NPWT systems, is minimally adherent.

17) Do you have any special recommendations for high bioburden or infection? Debridement is indicated in the presence of high amounts of bioburden. Wound infection is NOT a contraindication for NPWT, so we make no special recommendations.

18) How is your device billed? (Is the machine rented and how are supplies obtained?) The Kalypto NPD 1000 NPWT system is verified to the Medicare E2402 code and our dressings are verified to the A6550 dressing code. The devices are rented to patients locally by our many DME suppliers. The DME company works with local wound clinicians to provide access to the technology for the patients. In turn, the patient’s insurance company is billed for its use under the Part B DME benefit.

Spiracur, Inc. • Sunnyvale, CA • www.spiracur.com • 1-877-SPIRACUR (1-877-774-7228)

1) How many different NPWT products does your company currently produce? 1

2) Please name all of your NPWT related products?
  • SNaP™ Wound Care System
  • SNaP™ Wound Care Cartridge
  • SNaP™ Wound Care Dressing
  • SNaP™ Wound Care Strap

3) What is the suction pressure of your machine or the range of pressures that the machine achieves?
3 cartridges:
  • 75 mmHg
  • 100 mmHg
  • 125 mmHg

4) Is the pressure pre-set? Yes.

5) Can it be changed? Yes. Each dressing change, a new system is applied, at which time the clinician can choose the pressure setting (75 mmHg, 100 mmHg, 125 mmHg).

6) Is there an intermittent feature? No.

7) Is there a cut off which stops suction if the canister is full? Yes.

8) Is there a one-way valve to prevent fluid from coming back through the tubing towards the patient? Yes.

9) How long does the battery last? Infinitely. The SNaP™ System does not require a battery to deliver constant negative pressure.

10) How much does the machine weigh? (How portable is it?) < 3 oz (0.2 lbs) Designed to be worn beneath clothing.

11) What is the interface with the wound? Antimicrobial Gauze.

12) How often do you recommend changing the dressing? Two times per week.

13) Can you "y" wounds together and if so how many? Yes, 2.

14) How do you handle undermining? Standard protocol of lightly packed moistened gauze beneath the SNaP™ System’s custom hydrocolloid dressing.

15) How do you handle fistulas? Not indicated.

16) How do you handle exposed tendon or bone? Not indicated.

17) Do you have any special recommendations for high bioburden or infection? Appropriate debridement and antibiotic therapy.

18) How is your device billed? (Is the machine rented and how are supplies obtained?) The SNaP™ Wound Care System is not a rental product. Instead, the SNaP™ System is available off the shelf. Check with your insurance carrier concerning reimbursement.

ConvaTec • Skillman, NJ • www.convatec.com • 1 (800) 422-8811

1) How many different NPWT products does your company currently produce? ConvaTec markets one NPWT system, the Engenex® Advanced Negative Pressure Wound Therapy System, designed to be used with a range of non-adherent, non-woven polyester EasyRelease™ and Tunnel Dressings with unique Bio-Dome™ technology.

2) Please name all of your NPWT related products?
  • Engenex® Wound Flo™ Therapy Unit
  • EasyRelease™ Dressings with Bio-Dome™ Technology
  • Engenex® Wound Cover
  • Engenex® Tunnel Dressing
  • Opti-Flo™ Tube Attachment Device
  • Engenex® Canister

3) What is the suction pressure of your machine or the range of pressures that the machine achieves? The Engenex® Wound Flo™ Therapy Unit provides therapeutic levels of negative pressure at 30-75mmHg.

4) Is the pressure pre-set? No, the level of therapeutic negative pressure is not pre-set.

5) Can it be changed? Yes, the level of therapeutic negative pressure is set by the clinician using the negative pressure setting selector on the top of the therapy unit.

7) Is there an intermittent feature? Yes, the Engenex® Wound Flo™ Therapy Unit offers the application of either continuous or intermittent negative pressure, selected via the power/mode selector on the top of the therapy unit.

8) Is there a cut off which stops suction if the canister is full? The Engenex® Canister contains an integral filter to prevent overflow and a gelling agent to absorb and solidify the contents of the canister. As the gelling unit absorbs and solidifies the exudate, the filter becomes saturated. Once the capacity is reached, the Engenex® WoundFlo™ Therapy Unit will automatically shut off to prevent overflow. Visual and audible indicators on the Engenex® WoundFlo™ Therapy Unit notify the user when the canister is full.

9) Is there a one-way valve to prevent fluid from coming back through the tubing towards the patient? The Engenex® canister has a 1.2 micron filter shut off that keeps fluid from backing into the wound. The Tube Attachment Device (T.A.D.) includes a controlled filter vent. The vent works in combination with the flow detection system of the pump to provide information on system performance.

10) How long does the battery last? Maximum battery life is 16 hours.

11) How much does the machine weigh? (How portable is it?) The Engenex® Wound Flo™ Therapy Unit weighs approximately five (5) pounds. Its lightweight and convenient carrying case make it fully portable.

12) What is the interface with the wound? The wound contact dressing is a permeable dressing that is placed over or in the wound to facilitate the application of negative pressure to wounds. The wound dressing is comprised of non-woven polyester layers joined by a silicone elastomer and incorporates the unique Bio-Dome™ technology to promote healing. There are several types of non-adherent EasyRelease™ dressings available, including Thin Double-Sided, Double-Sided Thin and Tunnel dressings.

13) How often do you recommend changing the dressing? The Bio-Dome™ Wound Dressing, Wound Cover and Opti-Flo™ Tube Attachment Device should be replaced every 48 hours or as clinically indicated. For infected wounds, dressings should be changed every 12-24 hours, or the clinician may change more frequently if indicated.

14) Can you "y" wounds together and if so how many? Yes, one can “y” together two wounds, as long as they are of the same etiology. No more than one y-connector can be used per pump.

15) How do you handle undermining? Undermining is managed by filling the undermined area with a Bio-Dome™ EasyRelease™ Double Sided Thin Dressing that has been cut to fit. The dressing may be doubled over for undermined areas with greater depth.

16) How do you handle fistulas? The Engenex® Advanced Negative Pressure Therapy System is contraindicated for unexplored fistulas and non-enteric fistulas.

17) How do you handle exposed tendon or bone? Cover exposed blood vessels, organs, tendons; ligaments and nerves with multiple layers of fine mesh non-adherent dressings. Where appropriate, multiple layers of fine mesh non-adherent dressings should be used to protect delicate tissues.

18) Do you have any special recommendations for high bioburden or infection? Clinical signs of infection or high bioburden should be medically managed as deemed appropriate by the attending physician. The Engenex® Advanced Negative Pressure Therapy System may be used in the presence of high bioburden or infection.

Kinetic Concepts, Inc. (KCI) • San Antonio, Texas • www.kci1.com • (800) 275-4524

1) How many different NPWT products does your company currently produce? 5

2) Please name all of your NPWT related products used in the clinic setting?
  • ActiV.A.C.® Therapy System
  • InfoV.A.C.® Therapy System
  • V.A.C. Freedom® Therapy System

3) What is the suction pressure of your machine or the range of pressures that the machine achieves?
  • The ActiV.A.C.® Therapy System: -25 mmHg through -200 mmHg (-3.3 kPa to -26.6 kPa)
  • InfoV.A.C.® Therapy System: -25 mmHg through –200 mmHg (-3.3 kPa to -26.6 kPa)
  • V.A.C. Freedom® Therapy System: - 50-200 mmHg

4) Is the pressure pre-set?
  • The ActiV.A.C.® Therapy System- Default settings are -125mmHg and Continuous Therapy
  • InfoV.A.C.® Therapy System- Default settings are -125mmHg and Continuous Therapy
  • V.A.C. Freedom® Therapy System- Default setting is -125mmHg and Continuous Therapy

5) Can it be changed? Yes, for all units.

6) Is there an intermittent feature? Yes, for all units.

7) Is there a cut off which stops suction if the canister is full? Yes, for all units. Electronic sensors in the unit stop the pump when canister is full.

8) Is there a one-way valve to prevent fluid from coming back through the tubing towards the patient? The SensaT.R.A.C.™ Tubing has clamps at both the patient and canister side. Canisters are available with a gel pack that helps to solidify wound exudate.

9) How long does the battery last?
  • The ActiV.A.C.® Therapy System- Battery Life: 14 hour average
  • InfoV.A.C.® Therapy System- 6 hour average
  • V.A.C. Freedom® Therapy System- Approximately 12 hours

10) How much does the machine weigh? (How portable is it?)
  • The ActiV.A.C.® Therapy System (is portable)- 2.4 lbs (1.08 kg) with an empty 300ml canister
  • InfoV.A.C.® Therapy System- 6.4 lbs. (2.9 kg) with empty 500 ml canister
  • V.A.C. Freedom® Therapy System- 3.20 lbs. (1.45 kg) without canister and is portable

11) What is the interface with the wound?
All Wound Dressings are Latex Free:
  • V.A.C.® GranuFoam™ Dressing
  • V.A.C. GranuFoam Silver® Dressing
  • V.A.C.® WhiteFoam Dressing
  • V.A.C.® Simplace™ Dressing
  • V.A.C.® GranuFoam™ Bridge Dressing
  • Additional V.A.C.® GranuFoam™ specialty dressings are available.

12) How often do you recommend changing the dressing? For complete V.A.C.® Therapy System dressing recommendations, please refer to the V.A.C.® Therapy Clinical Guidelines, A Reference Source For Clinicians issued May 2010, located on www.kci1.com and dressing specific Instructions for Use are provided with each carton of dressings.

Wounds being treated with the V.A.C.® Therapy System should be monitored on a regular basis. In a monitored, non-infected wound, V.A.C.® Dressings should be changed every 48 to 72 hours, but no less than 3 times per week, with frequency adjusted by the clinician as appropriate. Also see question 17.

13) Can you "y" connect wounds together and if so how many? Yes. Please refer to the V.A.C.® Therapy Clinical Guidelines, A Reference Source For Clinicians, for the V.A.C.® Therapy dressing application instructions specific to treating multiple wounds, located on pg. 46. No limit is specified. Instructions for Y- connecting are provided below.

Y-Connector Technique
  By applying a Y-connector to the canister tubing, one V.A.C.® Therapy Unit may be used to simultaneously treat multiple wounds on the same patient. If this technique is used, all dressed wound sites must be assessed for the seal integrity. The dressing should be collapsed. V.A.C.® GranuFoam™ Dressings and V.A.C GranuFoam Silver® Dressings should have a wrinkled appearance. There should be no hissing sounds.
• SensaT.R.A.C.™ Technology only senses one wound site, the side with the post (male port), even when multiple sites are being treated.
• Do not connect infected wounds with non-infected wounds through a Y-connector.
• Do not connect wounds with different etiology in which cross contamination may occur.
• Avoid using a Y-connector to connect wounds that would be optimally treated with differing pressure settings.
• Consider the Y-connector as an extension of canister tubing.
• It is not recommended to Y-connect grafts and/or flaps.

Change the Y-connector at least once a week or more frequently, as needed, when the canister is changed. Dispose of the Y-connector, the canister tubing and the canister in accordance with specific institution protocols or state and local regulations.

14) How do you handle undermining? Please refer to the V.A.C.® Therapy Clinical Guidelines, A Reference Source For Clinicians, for the V.A.C.® Therapy dressing application instructions specific to Undermining, located on pg. 48. Instructions are summarized below.

Undermining
  It is recommended that Continuous therapy be used in the presence of wound undermining.

Initial dressing application
1. Gently place V.A.C.® WhiteFoam Dressing in all undermined areas, beginning at the distal portion. Do not pack foam into undermined areas.
2. Pull foam back out 1—2 cm, leaving some foam in the wound to contact with the foam in the wound bed. This specific placement leaves the distal portion of the undermined area clear of foam, allowing the distribution of higher pressures to collapse the free areas of undermining together, encouraging the wound cavity edges to granulate together from the distal portion outward.
3. Monitor the amount of exudate and presence of granulation tissue at each dressing change.

nbsp; Subsequent dressing changes: When the exudate volume decreases and the presence of granulation tissue is noted, subsequent dressing changes must be altered in the following way:
1. Gently place the foam into the undermined areas all the way to the distal portion. Do not pack foam into undermined areas.
2. Pull foam back out 1—2 cm, leaving some foam in the wound to contact with the foam in the wound bed. This specific placement leaves the distal portion of the undermined area clear of foam, allowing the distribution of higher pressures to collapse the free areas of undermining together, encouraging the wound cavity edges to granulate together from the distal portion outward.
3. Initiate Continuous therapy at previous settings.
4. Monitor the amount of exudate and presence of granulation tissue at each dressing change.

15) How do you handle fistulas? Please refer to the V.A.C.® Therapy Clinical Guidelines, A Reference Source For Clinicians, for the V.A.C.® Therapy dressing application instructions specific to Enteric Fistulas, located on pg. 48. Considerations for use of V.A.C.® Therapy when treating enteric fistulas are provided below.

  In certain circumstances, V.A.C.® Therapy may help to promote healing in wounds with an enteric fistula. If considering V.A.C.® Therapy involving enteric fistula, it is recommended to seek support from an expert clinician V.A.C.® Therapy is not recommended or designed for fistula effluent management or containment, but as an aid to wound healing in and around the fistula.

  The goal of therapy depends on whether the fistula being treated is considered acute or chronic.
• For acute fistula, the goal is to promote closure of the acute enteric fistula.
• For chronic fistula, the enterocutaneous fistula is segregated from the surrounding or adjacent abdominal wound and V.A.C.® Therapy is applied to the wound. The effluent from the fistula is diverted into another containment system. This allows time for the patient’s overall health to stabilize and sufficient healing to take place to enable subsequent surgical repair.

Fistula Management
• Enteric Fistula
• Acute Formation: No evidence of epithelial cells/growth on opening of fistula
• Fistula opening must be easily visualized and accessed
• NPO (Nothing by Mouth)
• TPN (Total Parental Nutrition)
• Minimal to moderate amounts of effluent
• Effluent is thin to slightly viscous consistency

Chronic Candidate Selection
• Enteric Fistula – non-surgical candidate
• Chronic Formation: Evidence of epithelial cells/growth (stomatization)
• Mouth of fistula must be easily visualized an accessed
• NPO (Nothing by Mouth)
• TPN (Total Parental Nutrition)

16) How do you handle exposed tendon or bone? Please refer to the V.A.C.® Therapy Clinical Guidelines, A Reference Source For Clinicians, for the V.A.C.® Therapy dressing application instructions, specific to exposed tendon located on pg. 69 and specific to exposed bone located on pg. 70. Instructions are summarized below.

  Tendons, ligaments, blood vessels, organs and nerves (vital structures) must be completely covered and protected prior to the administration of V.A.C.® Therapy. Coverage with a muscle flap or other thick layer of natural tissue provides the most effective protection. If not available, consider using non-adherent porous material (i.e. fine mesh gauze) or bioengineered tissue.

  V.A.C.® Therapy should not be initiated on a wound with osteomyelitis until the wound has been thoroughly debrided of all necrotic, non-viable tissue, including infected bone (if necessary), and appropriate antibiotic therapy has been initiated.

  In acute wounds with exposed bone or fractures, the V.A.C.® System may be used to help remove fluid and may remove infectious material secondary to the traumatic wound.

17) Do you have any special recommendations for high bioburden or infection? Infected wounds must be monitored often and very closely. For these wounds, dressings may need to be changed more often than 48-72 hours; the dressing change intervals should be based on a continuing evaluation of wound condition and the patient’s clinical presentation, rather than a fixed schedule.

18) How is your device billed? (Is the machine rented and how are supplies obtained?) The units are rented and the disposable dressings are for purchase.

  Federal law restricts the V.A.C.® Therapy device to sale or rental by or on the order of a physician.

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.

CAUTION: Federal law restricts this device to sale/rental by or on the order of a physician.