V.A.C. Therapy Safety Information

Transcription

1 Bringing Safety Home V.A.C. Therapy Safety Information Bleeding Precautions Dressing Change Frequency Foam Removal

2 Important Information 2 Prior to use of V.A.C. Therapy System it is important for the provider to: Consult the treating physician Read and understand all Instructions for Use, including Safety Information, and Dressing Application Instructions. KCI recommends that clinicians participate in device in-service and training prior to use. Unless otherwise specifically noted, all trademarks designated herein are proprietary to KCI Licensing, its affiliates and licensors. Rx only.

3 3 Bleeding Safety Measures Pre-Placement V.A.C. Therapy Considerations Has the wound stopped bleeding? (Hemostasis) Does the patient have weakened or friable blood vessels? Are there exposed vessels in wound? Does the patient have a fresh anastamosis or vessel graft? Was the wound due to severe trauma? Is the wound infected? Has the patient had radiation treatments? Is the patient on anticoagulants? With or without using V.A.C. Therapy, certain wound care patients are at high risk of bleeding complications.

4 4 Bleeding Safety Measures Has the wound stopped bleeding and has hemostasis been achieved? Do not initiate V.A.C. Therapy until hemostasis is achieved. If V.A.C. Therapy is prescribed for patients who have increased risk of bleeding complications, they should be treated and monitored in a care setting deemed appropriate by the treating physician. Patients without adequate wound hemostasis have an increased risk of 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 If active bleeding develops suddenly or in large amounts during VA 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, leaving 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 to prevent, minimize or stop vascular bleeding.

5 5 Bleeding Safety Measures Does the patient have weakened or friable blood vessels? Are there exposed vessels in the wound? Does the patient have a fresh (within the last 30 days) anastomosis or vessel graft? Was the wound due to trauma? Has the patient had radiation treatments? Patients t who have weakened or friable blood vessels or organs in or around wound as a result of suturing of the blood vessel(native anastomosis or grafts)/organs, infection, trauma or radiation are at risk of bleeding, which if uncontrolled could be fatal. All exposed or superficial vessels and organs in and 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 materials, 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. 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.

6 6 Bleeding Safety Measures Is the wound infected? Regardless of treatment modality, wound complications from peripheral vascular surgery, especially those situated in the groin, are not uncommon and have potential for severe consequences including significant blood loss from vessel rupture. Groin wound infections can be increasingly difficult to treat because of multiple comorbidities of patients undergoing vascular surgery for the wide array of resistant bacterial organisms in health care institutions. Surgical site infections are common in the groin area. 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 V.A.C Instill Therapy System). 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 lead to complications such as pain, discomfort, fever, gangrene, toxic shock, septic shock and or fatal injury. If there are any signs of the onset of systemic infection or advancing infection at the wound site, contact t a physician i immediately to determine if V.A.C Therapy should be discontinued.

7 7 Bleeding Safety Measures Is the patient on anticoagulant therapy? Caution should be used in treating patients on doses of anticoagulant or platelet aggregation g 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 deemed appropriate by the treating physician.

8 Wounds Bleed Expect some bleeding during dressing changes. Granulation tissue is full of brand new capillary buds that can easily be broken during the normal course of removing any type of dressing and cleaning a wound. Is the blood in the wound bed serosanguinous or frank? Serosanguinous blood looks like clear liquid mixed with blood while frank blood looks like a fresh cut. A clinician may also show a patient what serosanguinous blood looks like on a dressing and instruct the patient or caregiver to call the nurse if the blood changes.

9 Where to Seek Help & Advice 9 Facility Setting First call attending or on-call physician Contact KCI 24-hr Customer Care Last contact local KCI representative STOP VA V.A.C. Therapy LEAVE THE DRESSING IN PLACE Take measures to stop the bleeding by applying pressure to the wound and seek immediate medical assistance Home Setting First call 911 for bleeding that won t stop Then, call the physician Report the issue to the g Home Health Agency Last contact KCI 24-hr Customer Care

10 10 Dressing Change Frequency Some wounds granulate faster than others. Change dressing Q48-72hrs 72hrs, no less than 3 times per week. Increase frequency of dressing changes if foam is difficult to remove. Base dressing change intervals on wound characteristics and clinical presentation, not fixed schedule, but no less than 3 times per week.

11 11 Foam Removal Do not leave foam in the wound. 1. Count 2. Label 3. Chart Avoid in-growth! Remove equal numbers of foam placed. Adhered foam may cause painful dressing changes.

12 Dressing Change Safety Reminders Avoid leaving V.A.C. Therapy Dressing in place without negative pressure for more than 2 hours. GranuFoam is hydrophobic and will not readily absorb wound exudate. Leaving the exudate in the wound may allow for bacteria growth. Remove old dressing and irrigate the wound after therapy is off more than 2 hours Apply a new V.A.C. Dressing or alternative dressing per MD orders. Teach patients & families why 22 hour therapy is important. Provide alternate locations if their physician or HHA is not available to change the dressing. (WCC, ER, etc. ) Alternative plans are very important for home patients with ANY kind of medical equipment and V.A.C. Therapy is no exception. Count, Count, Count! Dressing pieces placed in & taken out of the wound.

13 Clinical Guidelines Updates: Risk of bleeding at foam removal pg 14 Foam count documentation Transfer patients with increased bleeding risk to appropriate care setting. SensaT.R.A.C. /T.R.A.C. Pad application pg 28 Y-Connecting pg 46 Pain management pg 65 Monitor pressure & therapy settings. Avoid placing foam in direct contact with organs or vessels. Enteric Fistula pg 87 V.A.C. Instill pg 91 Additional Instructions: Considerations for transitioning V.A.C. Therapy into home care pg 18 V.A.C. Simplace Foam Dressing pg 31 V.A.C. GranuFoam Bridge Dressing pg 31 Lower extremity Vascular Surgical Wounds pg 70 Venous Insufficiency Ulcer Dressing Application Teach patients & families bleeding precautions. Use non-adherent material underneath foam dressing to help minimize bleeding potential. Protect vessels & organs.

14 14 FDA Reporting Requirements Go to Recommendations Select patients for NPWT carefully, after reviewing the most recent device labeling and instructions. Know that: NPWT systems are contraindicated d for certain wound types (Table 1), and Patient risk factors (Table 2) must be thoroughly considered before use. Assure that the patient is monitored frequently in an appropriate care setting by a trained practitioner. With any wound care treatment, be vigilant for potentially life-threatening complications, such as bleeding, and be prepared to take prompt action if they occur.

15 15 Patient Selection Considerations Table 1: V.A.C. Therapy contraindications: necrotic tissue with eschar present untreated osteomyelitis non-enteric and unexplored fistulas malignancy in the wound exposed vasculature exposed nerves exposed anastomotic site exposed organs

16 16 Patient Selection Considerations Table 2: Patient risk factors/characteristics to consider before V.A.C. Therapy use: Patients at high risk for bleeding and hemorrhage Patients on anticoagulants or platelet aggregation inhibitors Spinal cord injury (stimulation of sympathetic nervous system) Enteric fistulas Patients with: Friable vessels and infected blood vessel MRI Patients requiring: Vascular anastomosis Hyperbaric chamber Infected wounds Defibrillation Untreated osteomyelitis Patient size and weight Exposed organs, vessels, nerves, tendon, and ligaments Sharp edges in the wound (i.e. bone fragments) Use near vagus nerve (bradycardia) Circumferential dressing application

17 17 Transitioning Patients Safely Hospital SNF Home Report & chart foam count between OR & Unit Remove & chart foam count q dressing change. Include foam count in d/c instructions. Confirm foam count present on admission. Remove & chart foam count q dressing change. Confirm foam present on admission. Remove & chart foam count q dressing change. Teach patients & family about importance of foam count and frequent dressing changes. VAC V.A.C. Therapy Be vigilant for potentially life-threatening complications, such as bleeding, and be prepared to take prompt action if they occur.

18 18 Transitioning Patients Safely 24 hour Home Patient Support and training by KCI Team Comprehensive Product Labeling & Clinical Guidelines Patient Safety Guide and DVD Patient Safety Instructions Brochure V.A.C. Therapy Review all V.A.C AC Therapy safety information with patient and caregiver prior to home use

19 Your KCI Resources 24/7 Clinical & Technical Support Field Based V.A.C. Clinical Specialists Comprehensive Product Labeling & 2010 Clinical Guidelines Professional Education Accredited Education & Competency Testing

20 V.A.C. Therapy Clinical Guidelines