V.A.C.® Therapy Indications and Safety Information

V.A.C. Therapy Safety Information

Disposable components of the V.A.C. (Vacuum Assisted Closure) Therapy System, including the foam dressing kits (i.e., V.A.C. GranuFoam^™, V.A.C. GranuFoam Silver^®, or V.A.C. WhiteFoam Dressing) and V.A.C. Therapy accessories are packaged sterile and are latex-free. V.A.C. Therapy Unit canisters are packaged sterile or with sterile fluid path and are latex-free. All disposable components of the V.A.C. Therapy System are for single use only. To help ensure safe and effective use, the V.A.C. GranuFoam, V.A.C. GranuFoam Silver, and V.A.C. WhiteFoam Dressings are to be used only with V.A.C. Therapy Units.

The decision to use clean versus sterile/aseptic technique is dependent upon wound pathophysiology, doctor preference, and institutional protocol.

IMPORTANT: As with any prescription medical device, failure to consult a doctor and carefully read and follow all therapy unit and dressing instructions and safety information prior to each use may lead to inadequate performance of the product and the potential for serious or fatal injury. Do not adjust therapy unit settings or use unit without directions from or supervision by the prescribing doctor.

Indications for Use

The ActiV.A.C.®, InfoV.A.C. ®, V.AC. ATS® and V.A.C. Freedom® Negative Pressure Wound Therapy Systems (NPWT) are integrated wound management systems for use in acute, extended and home care settings. They are intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing oedema¹⁰, promoting granulation tissue formation^12,13 and perfusion^12,19,and by removing exudate¹² and infectious material⁶. It is indicated for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.

The V.A.C. GranuFoam Silver Dressing is an effective barrier to bacterial penetration and may help reduce infection in the types of wounds listed above¹⁷.

Contraindications

Do not place foam dressings of the V.A.C. Therapy System directly in contact with exposed blood vessels, anastomotic sites, organs, or nerves.

NOTE: Refer to Warnings section for additional information concerning Bleeding

V.A.C. Therapy is contraindicated for patients with:

Malignancy in the wound
Untreated osteomyelitis

NOTE: Refer to Warnings section for Osteomyelitis information.

Non-enteric and unexplored fistulas
Necrotic tissue with eschar present

NOTE: After debridement of necrotic tissue and complete removal of eschar, V.A.C.Therapy may be used.

Sensitivity to silver (V.A.C. GranuFoamSilver Dressing only).

Warnings

Bleeding

With or without using V.A.C. Therapy, certain patients are at high risk of bleeding complications. The following types of patients are at increased risk of bleeding, which, if uncontrolled, could be potentially fatal.

Patients who have weakened or friable blood vessels or organs in or around the wound as a result of, but not limited to:
- Suturing of the blood vessel (native anastamosis or grafts)/organ
- Infection
- Trauma
- Radiation
Patients without adequate wound hemostasis
Patients who have been administered anticoagulants or platelet aggregation inhibitors
Patients who do not have adequate tissue coverage over vascular structures.

If V.A.C. Therapy is prescribed for patients who have an increased risk of bleeding complications, they should be treated and monitored in a care setting deemed appropriate by the treating physician.

If active bleeding develops suddenly or in large amounts during V.A.C. Therapy, or if frank (bright red) blood is seen in the tubing or in the canister, immediately stop V.A.C. Therapy, leave dressing in place, take measures to stop the bleeding, and seek immediate medical assistance. The V.A.C. Therapy Units and dressings should not be used toprevent, minimize or stop vascular bleeding.

Protect Vessels and Organs: All exposed or superficial vessels and organs in or around the wound must be completely covered and protected prior to the administration of V.A.C. Therapy.

Always ensure that V.A.C. Foam Dressings do not come in direct contact with vessels or organs. Use of a thick layer of natural tissue should provide the most effective protection. If a thick layer of natural tissue is not available or is not surgically possible, multiple layers of fine-meshed, non-adherent material, or bioengineered tissue may be considered as an alternative, if deemed by the treating physician to provide a complete protective barrier. If using non-adherent materials, ensure that they are secured in a manner as to maintain their protective position throughout therapy.

Consideration should also be given to the negative pressure setting and therapy mode used when initiating therapy.

Caution should be taken when treating large wounds that may contain hidden vessels, which may not be readily apparent. The patient should be closely monitored for bleeding in a care setting deemed appropriate by the treating physician.

Infected Blood Vessels: Infection may erode blood vessels and weaken the vascular wallwhich may increase susceptibility to vessel damage through abrasion or manipulation. Infected blood vessels are at risk of complications, including bleeding, which, if uncontrolled, could be potentially fatal. Extreme caution should be used when V.A.C. Therapy is applied in close proximity to infected or potentially infected blood vessels. (Refer to Protect Vessels and Organs section above.)

Hemostasis, Anticoagulants, and Platelet Aggregation Inhibitors: Patients without adequate wound hemostasis have an increased risk of bleeding, which, if uncontrolled, could be potentially fatal. These patients should be treated and monitored in a care setting deemed appropriate by the treating physician.

Caution should be used in treating patients on doses of anticoagulants or platelet aggregation inhibitors thought to increase their risk for bleeding (relative to the type and complexity of the wound). Consideration should be given to the negative pressure setting and therapy mode used when initiating therapy.

Hemostatic Agents Applied at the Wound Site: Non-sutured hemostatic agents (for example, bone wax, absorbable gelatin sponge, or spraywound sealant) may, if disrupted, increase the risk of bleeding, which, if uncontrolled, could be potentially fatal. Protect against dislodging such agents. Consideration should be given to the negative pressure setting and therapy mode used when initiating therapy.

Sharp Edges: Bone fragments or sharp edges could puncture protective barriers, vessels, or organs causing injury. Any injury could cause bleeding, which, if uncontrolled, could be potentially fatal. Beware of possible shifting in the relative position of tissues, vessels or organs within the wound that might increase the possibility of contact with sharp edges. Sharp edges or bone fragments must be eliminated from the wound area or covered to prevent them from puncturing blood vessels or organs before the application of V.A.C. Therapy. Where possible, completely smooth and cover any residual edges to decrease the risk of serious or fatal injury, should shifting of structures occur. Use caution when removing dressing components from the wound so that wound tissue is not damaged by unprotected sharp edges.

1000 ml Canister Size

DO NOT USE the 1000 mL canister on patients with a high risk of bleeding or on patients unable to tolerate a large loss of fluid volume, including children and the elderly. Consider the size and weight of the patient, patient condition, wound type, monitoring capability and care setting when using this canister. This canister is recommended for acute care (hospital) use only.

Infected Wounds

Infected wounds should be monitored closely and may require more frequent dressing changes than non-infected wounds, dependent upon factors such as wound conditions, treatment goals, and instillation therapy parameters (for the V.A.C. Instill Therapy System). Refer to dressing application instructions (found in V.A.C. Dressing cartons) for details regarding dressing change frequency. As with any wound treatment, clinicians and patients/caregivers should frequently monitor the patient’s wound, periwound tissue and exudate for signs of infection, worsening infection, or other complications. Some signs of infection are fever, tenderness, redness, swelling, itching, rash, increased warmth in the wound or periwound area, purulent discharge, or strong odor. Infection can be serious, and can lead to complications such as pain, discomfort, fever, gangrene, toxic shock, septic shock and/or fatal injury. Some signs or complications of systemic infection are nausea, vomiting, diarrhea, headache, dizziness, fainting, sore throat with swelling of the mucus membranes, disorientation, high fever, refractory and/orthostatic hypotension, or erythroderma (a sunburn-like rash). If there are any signs of the onset of systemic infection or advancing infection at the wound site, contact a physician immediately to determine if V.A.C. Therapy should be discontinued. For wound infections relating to blood vessels, please also refer to the section titled Infected Blood Vessels.

Infected Wounds with V.A.C. GranuFoam Silver Dressing

In the event of clinical infection, V.A.C. GranuFoam Silver dressing is not intended to replace the use of systemic therapy or other infection treatment regimens. V.A.C. GranuFoam Silver dressing may be used on infected wounds as an adjunct to the standard treatment regimen and to provide a barrier to bacterial penetration.

Osteomyelitis

The V.A.C. System should NOT be initiated on a wound with untreated
osteomyelitis. Consideration should be given to thorough debridement of all necrotic, nonviable tissue, including infected bone (if necessary), and appropriate antibiotic therapy.

Protect Tendons, Ligaments and Nerves

Tendons, ligaments and nerves should be protected to avoid direct contact with V.A.C. Foam Dressings. These structures may be covered with natural tissue, meshed non-adherent material, or bioengineered tissue to help minimize risk of desiccation or injury.

Foam Placement

Always use V.A.C. Dressings from sterile packages that have not been opened or damaged. Do not place any foam dressing into blind/unexplored tunnels. The
V.A.C. WhiteFoam Dressing may be more appropriate for use with explored tunnels. Do not force foam dressings into any area of the wound, as this may damage tissue, alter the delivery of negative pressure, or hinder exudate and foam removal. Always count the total number of pieces of foam used in the wound and document that number on the drape and in the patient’s chart. Also document the dressing change date on the drape.

Foam Removal

V.A.C. Foam Dressings are not bioabsorbable. Always count the total number of pieces of foam removed from the wound and ensure the same number of foam pieces was removed as placed. Foam left in the wound for greater than the recommended time period may foster ingrowth of tissue into the foam, create difficulty in removing foam from the wound, or lead to infection or other adverse events. If significant bleeding develops, immediately discontinue the use of the V.A.C. Therapy System, take measures to stop the bleeding and do not remove the foam dressing until the treating physician or surgeon is consulted. Do not resume the use of the V.A.C. Therapy System until adequate hemostasis has been achieved, and the patient is not at risk for continued bleeding.

Keep V.A.C. Therapy On

Never leave a V.A.C. Dressing in place without active V.A.C. Therapy for more than 2 hours. If therapy is off for more than 2 hours, remove the old dressing and irrigate the wound. Either apply a new V.A.C. Dressing from an unopened sterile package and restart V.A.C. Therapy; or apply an alternative dressing at the direction of the treating clinician.

Acrylic Adhesive

The V.A.C. Drape has an acrylic adhesive coating, which may present a risk of an adverse reaction in patients who are allergic or hypersensitive to acrylic adhesives. If a patient has a known allergy or hypersensitivity to such adhesives, do not use the V.A.C. Therapy System. If any signs of allergic reaction or hypersensitivity develop, such as redness, swelling, rash, urticaria, or significant pruritus, discontinue use and consult a physician immediately. If bronchospasmormore serious signs of allergic reaction appear, seek immediate medical assistance.

Defibrillation

Remove the V.A.C. Dressing if defibrillation is required in the area of dressing placement. Failure to remove the dressing may inhibit transmission of electrical energy and/or patient resuscitation.

Magnetic Resonance Imaging (MRI)—Therapy Unit

The V.A.C. Therapy Unit is MR Unsafe. Do not take the V.A.C. Therapy Unit into the MR environment.

Magnetic Resonance Imaging (MRI)—V.A.C. Dressings

V.A.C. Dressings can typically remain on the patient with minimal risk in an MR environment, assuming that use of the V.A.C. Therapy System is not interrupted for more than 2 hours (refer to Keep V.A.C. Therapy On). The V.A.C. GranuFoam Silver Dressing has been shown to pose no known hazards in an MR environment with the following conditions of use:

Static magnetic field of 3 Tesla or less,
Spatial gradient field of 720 Gauss/cm or less, and
Maximum whole-body-averaged specific absorption rate (SAR) of 3W/kg for 15 minutes of scanning.

Non-clinical testing under these same conditions produced a temperature rise of <0.4°C. MR image quality may be compromised if the area of interest is in the same area or relatively close to the position of the V.A.C. GranuFoam Silver dressing.

Hyperbaric Oxygen Therapy (HBO)

Do not take the V.A.C. Therapy Unit into a hyperbaric oxygen chamber. The V.A.C. Therapy Unit is not designed for this environment, and should be considered a fire hazard. After disconnecting the V.A.C. Therapy Unit, either (i) replace the V.A.C. Dressing with another HBO compatible material during the hyperbaric treatment, or (ii) cover the unclamped end of the V.A.C. Tubing with moist cotton gauze and completely cover the V.A.C. Dressing (including tubing) with a moist towel throughout the treatment in the chamber. For HBO therapy, the V.A.C. Tubing must not be clamped. Never leave a V.A.C. Dressing in place without active V.A.C. Therapy for more than 2 hours; please refer to the Keep V.A.C. Therapy On.

Precautions

Standard Precautions

To reduce the risk of transmission of bloodborne pathogens, apply standard precautions for infection control with all patients, per institutional protocol, regardless of their diagnosis or presumed infection status. In addition to gloves, use gown and goggles if exposure to body fluid is likely.

Continuous versus Intermittent V.A.C. Therapy

Continuous, rather than intermittent, V.A.C. Therapy is recommended over unstable structures, such as an unstable chest wall or non-intact fascia, in order to help minimize movement and stabilize the wound bed. Continuous therapy is also generally recommended for patients at increased risk of bleeding, highly exudating wounds, fresh flaps and grafts, and wounds with acute enteric fistulae.

Patient Size and Weight

The size and weight of the patient should be considered when prescribing V.A.C. Therapy. Infants, children, certain small adults and elderly patients should be closely monitored for fluid loss and dehydration. Also, patients with highly exudating wounds or large wounds in relation to the patient size and weight should be closely monitored, as they may have a risk of excessive fluid loss and dehydration. When monitoring fluid output, consider the volume of fluid in both the tubing and canister.

Spinal Cord Injury

In the event a patient experiences autonomic hyperreflexia (sudden elevation in blood pressure or heart rate in response to stimulation of the sympathetic nervous system), discontinue V.A.C. Therapy to help minimize sensory stimulation and seek immediate medical assistance.

Bradycardia

To minimize the risk of bradycardia, the V.A.C. Therapy Dressing must not be placed in proximity to the vagus nerve.

Enteric Fistulas

Wounds with enteric fistulas require special precautions to optimize V.A.C. Therapy. Refer to (p. 56) for more details. V.A.C. Therapy is not recommended if enteric fistula effluent management or containment is the sole goal of this therapy.

Protect Periwound Skin

Consider use of a skin preparation product to protect periwound skin. Do not allow foam to overlap onto intact skin. Protect fragile/friable periwound skin with additional V.A.C. Drape, hydrocolloid or other transparent film.

Multiple layers of the V.A.C. Drape may decrease the moisture vapor transmission rate, which may increase the risk of maceration.
If any signs of irritation or sensitivity to the drape, foam or tubing assembly appear, discontinue use and consult a physician.
To avoid trauma to the periwound skin, do not pull or stretch the drape over the foam dressing during drape application.
Extra caution should be used for patients with neuropathic etiologies or circulatory compromise.

Circumferential Dressing Application

Avoid use of circumferential dressings except in the presence of anasarca or excessively weeping extremities, where a circumferential drape technique may be necessary to establish and maintain a seal. Consider using multiple small pieces of V.A.C. Drape rather than one continuous piece to minimize the risk of decreased distal circulation. Extreme care should be taken not to stretch or pull the drape when securing it, but let it attach loosely and stabilize edges with an elastic wrap if necessary. When using circumferential drape techniques, it is crucial to systematically and recurrently palpate distal pulses and assess distal circulatory status. If circulatory compromise is suspected, discontinue therapy, remove dressing and contact a physician.

V.A.C. Therapy Unit Pressure Deviations

In rare instances, tubing blockages with the
V.A.C. Therapy Units may result in brief vacuum excursions to more than 250mmHg negative pressure. Resolve alarm conditions immediately. Refer to User’s Guide or contact your KCI representative for additional information.

Additional Precautions for V.A.C. GranuFoam Silver Dressing

Topical Solutions or Agents

When using the V.A.C. GranuFoam Silver Dressing, do not use topical solutions or agents that may have adverse interactions with silver. For example, saline solutions may compromise the effectiveness of the V.A.C. GranuFoam Silver Dressing.

Protective Layer

For maximum effectiveness, the V.A.C. GranuFoam Silver Dressing should be applied directly to the wound surface to enhance optimal contact of the tissue with the foam/silver interface. However, as with all V.A.C. Foam Dressings, the V.A.C. GranuFoam Silver Dressing should not be placed in direct contact with exposed blood vessels, anastomotic sites, organs, or nerves (refer to section on Protect Vessels and Organs). Intervening non-adherent layers may be placed between the V.A.C. GranuFoam Silver Dressing and the wound surface; however, these products may compromise the effectiveness of the V.A.C. GranuFoam Silver Dressing in the area covered by the non-adherent layer.

Electrodes or Conductive Gel

Do not allow V.A.C. GranuFoam Silver Dressing to come in contact with EKG or other electrodes or conductive gels during electronic monitoring or when taking electronic measurements.

Diagnostic Imaging

The V.A.C. GranuFoam Silver Dressing contains metallic silver that may impair visualization with certain imaging modalities.

Dressing Components

The V.A.C. GranuFoam Silver Dressing contains elemental silver (10%) as a sustained release formulation. Application of products containing silver may cause temporary tissue discoloration.

Additional warnings and precautions apply to certain V.A.C. specialty dressings and V.A.C. Therapy Units, such as the V.A.C. Abdominal Dressing and V.A.C. Instill Therapy System. Please refer to the specific product Instructions for Use prior to use.

V.A.C. Abdominal Dressing Indications

This specialty dressing is indicated for:

Temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary
Open abdominal wounds, with exposed viscera, including, but not limited, to abdominal compartment syndrome

Specific Precautions for the V.A.C. Abdominal Dressing System

The V.A.C. Abdominal Dressing is best used in the patient without hemorrhage whose abdominal contents are sufficiently edematous to preclude safe abdominal closure.
Special precaution should be taken with patients with ongoing or high potential for hemorrhage and/or enteric leak. Patient assessments should be made to ascertain the status of the gastrointestinal tract.
Warning: Patients with severe abdominal trauma and abdominal compartment syndrome have a high mortality rate. Careful attention is required, irrespective of whether the V.A.C. Abdominal Dressing is being used.

V.A.C. GranuFoam Silver Dressing Indications

The V.A.C. GranuFoam Silver Dressing is an effective barrier to bacterial penetration and may help reduce infection in the above wound types.

Additional Precautions for V.A.C. GranuFoam Silver Dressing

Topical Solutions or Agents

Protective Layer

Electrodes or Conductive Gel

Do not allow V.A.C. GranuFoam Silver Dressing to come in contact with EKG or other electrodes or conductive gels during electronic monitoring or when taking electronic measurements.

Diagnostic Imaging

The V.A.C. GranuFoam Silver Dressing contains metallic silver that may impair visualization with certain imaging modalities.

Dressing Components

The V.A.C. GranuFoam Silver Dressing contains elemental silver (10%) as a sustained release formulation. Application of products containing silver may cause temporary tissue discoloration.

V.A.C. Instill Therapy System Indications

Indications

The V.A.C. Instill System is indicated for patients who could benefit from V.A.C. Instill Therapy coupled with controlled delivery and drainage of topical wound treatment solutions and suspensions over the wound bed. This includes patients who would benefit from removal of infectious material or fluids from wounds under the influence of continuous negative pressure.

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