Versatile 1™ Wound Vacuum System Clinical Guidelines A. PURPOSE: To provide the staff with a guideline for the suggested implementation and management of the Versatile 1 Wound Vacuum System. B. DEFINITION: The BlueSky Versatile 1 Wound Vacuum System is a system designed to apply localized negative pressure to the wound bed. It consists of the pump (Versatile 1) to provide negative pressure, a silicon drain to serve as a pathway to apply the negative pressure, saline moistened gauze to fill any dead space, (optional) non-adherent gauze for wound bed protection, and an occlusive dressing. The negative pressure removes interstitial fluid and wound exudate, increases vascular perfusion, promotes granulation tissue and contracts the wound edges. Wounds types and criteria for negative pressure are: pressure ulcers, Diabetic/Neuropathic ulcers, Venous ulcers, explored fistulas, traumatic wounds, dehisced surgical incisions, pre/post-op skin flaps and grafts. C. POLICY: 1) A physician order is required to initiate the Versatile 1 Wound Vacuum System. 2) For telephone and verbal orders: Write down the order for the Versatile 1 and then read back to the prescriber for verification. All orders should include the wound site, specific wound sealing kit (identified by the choice of drain), pressure setting, and frequency of dressing change. Drain choice should be based on the Kit Component and Drain Guide. 3) Wound Utilization Considerations: 1) Traditional wound care has not been effective in healing the wound. (4 – 6 weeks) 2) The wound is expected to take months to resolve. 3) The wound bed has 70% clean, viable tissue. The wound may have 30% or less necrotic slough. 4) The wound has sufficient blood flow to allow healing. 5) The wound has significant depth and drainage. 6) The patient is receiving adequate nutrition to allow healing. 7) The wound is anatomically located to support the adherence of the dressing in order to maintain a seal to create negative pressure. 8) If the Versatile 1 Wound Vacuum System is to be continued through a home health agency/outpatient setting, the patient or caregiver must be willing/able to manage canister changing/emptying and the removal of the Versatile 1 system and application of a normal saline dressing if problems with the device occur. 4) Contraindications: 1) Unexplored fistula 2) Untreated Osteomyelitis 3) Malignancy (except in palliative care) 4) Exposed vessels, organs or major structures. Precautions: 5) Patients on anticoagulants 6) Have difficult hemostais 7) Noncompliant/ combative/ unsuitable 8) Untreated for malnutrition Carefully assess wounds that are: 9) Necrotic w/eschar present 5) Prior to the placement of the Versatile 1 Wound Vacuum System over an open wound, the designated wound care clinician must assess the wound/patient to ensure the clinical indications and the wound utilization considerations for the NPWT are met. 6) BlueSky Medical Group, Inc. is the vendor who manufactures the Versatile 1. The components of the Versatile 1 Wound Vacuum System are obtained from an Approved BlueSky Medical Distributor. The local distributor can be reached via the following information: Decubex Diversified Health Systems® 1025 Blanding Boulevard, Suite 503 Orange Park, Florida USA 32065 telephone: 800-332-8239 www.decubex.com 7) The surgeon may choose to place the Versatile 1 on the patient in the OR in conjunction with other procedures. 8) Please note that the Versatile 1 unit requires cleaning by either the Approved BlueSky Distributor or through the facility central supply prior to use on another patient. This procedure needs to be determined prior to placement. D. RESPONSIBILITIES: 1) The patient is to be assessed for need and indication for use of the V1 Wound Vacuum System by the facility designated wound care clinician. 2) When it is determined that the Versatile 1 is indicated for use, the designated wound care clinician will begin the ordering process, as determined by the facility and the Approved BlueSky Medical Group, Inc. distributor. The ordering process should include the following: Wound Sealing Kits with appropriate drain. See Kit Component and Drain Guide for choosing the appropriate drain. Canister Kits Any needed tubing’s or filters E. 3) The Versatile 1 can be placed by an MD, PT, or Nurse as determined by the facility. 4) Monitoring of the Versatile 1, canister management, repairing an air leak in the dressing, and dressing removal can be performed by an MD, PT or Nurse as determined by the facility. PERSONNEL: Physician (MD/DO) Registered Nurse (RN) Licensed Practical Nurse/Licensed Vocational Nurse (LPN/LVN) Wound/Ostomy/Continence Nurse (WOCN) Physical Therapist (PT) Other Wound Care Specialist or ET F. EQUIPMENT/SUPPLIES: Versatile 1 Wound Vacuum Pump Versatile 1 Wound Sealing Kit Scissors Gloves Normal saline Skin prep G. PROCEDURES: a) Application 1) 2) 3) 4) 5) 6) 7) 8) 9) 10) 11) 12) 13) 14) 15) 16) 17) 18) Explain the procedure to the patient. Assess the patient for any pain issues relating to the dressing change and premedicate as needed. Assemble equipment. Provide privacy. Position patient. Ensure pump is off. Apply gloves. Remove the dressing over the wound and discard in the biohazardous waste container. Change gloves. Irrigate wound with normal saline or wound cleanser as ordered by the physician and pat dry. Apply skin prep to wound edges and allow to dry. Measure and cut drain to length of wound less 1” to allow for wound contraction. (Option 1) Cut single layer of non-adherent gauze to size and shape of wound bed. Place in wound bed. (Option 2) If non-adherent gauze is not used, place the drain between saline moistened gauze to create a layer of gauze between the wound bed and the drain. The drain is never placed directly on the wound bed. Fill any dead space with saline moistened gauze. Cover entire wound with transparent film covering at least 1” of intact peri wound skin to ensure an occlusive seal. Crimp or pinch transparent film around drain where it exits the wound bed. Stomahesive paste or hydrocolloid may be used to assist with obtaining a seal. Connect the drain tube to the Connecting Tubing. Connect the Connecting Tubing to the patient port on the canister. Be sure the tubing clamps are in the open position. 19) Turn on the unit and observe for contraction of the wound dressing. If the wound does not visibly contract and become “hard to the touch”, there is a leak present. Patch the leak with a transparent dressing, waterproof tape or Stomahesive paste. 20) Set the unit for the prescribed negative pressure. The order for therapeutic pressure is based on the type of wound being treated. Pressure ulcers, venous wounds, dehisced surgical sites, Diabetic/Neuropathic ulcers receive 60-80 mm Hg on the “Continuous” setting. Fistula drainage and management, traumatic wounds, pre-op flaps/grafts, post-op flaps/grafts suggested vacuum pressure setting is per clinician discretion using the “Continuous” mode. NOTE: Do Not Connect To Wall Suction. 21) If required by the facility, document on the patient’s medical record the time of the dressing change, the wound dimensions and appearance. 22) The first dressing change should be at 48hrs. Then, if the patient is comfortable and the pump is effective at managing the exudate, the dressing should be changed 2-3x/wk. b) Disconnecting from the Versatile 1 1) Clamp tubing. 2) Turn power off. 3) Disconnect. 4) Apply clean cover to the end of the drain when disconnected from the pump. (i.e. waterproof tape) c) Versatile 1 Canister Change Follow facility policy for discarding bodily fluids. d) Versatile 1 Maintenance 1) The battery will last up to 2 hours. The battery is continuously charged when plugged into an electrical outlet. 2) If the dressing is accidentally removed and the wound care staff is unavailable for reapplying the Wound Sealing Kit, simply apply and secure normal saline moistened gauze to the wound bed and notify the wound care staff for reapplication. e) Versatile 1 Discontinuation 1) A Physician order is required to permanently discontinue Versatile 1 Wound Vacuum System. 2) The wound care staff can remove and discard the dressing and canister according to facility Infection Control Policy for discarding biohazardous material. 3) Apply normal saline moistened gauze dressing or other dressing as ordered by the physician over the wound. 4) Notify the Approved BlueSky Medical Distributor of the discontinuation of the NPWT. The arrangement for pick up should be determined prior to placement. f) Patient Discharge with the Versatile 1 Wound Vacuum System 1) Case Manager or Home Care Coordinator will evaluate and coordinate with the Approved BlueSky Sales Representative for ongoing Versatile 1 therapy. 2) Upon transfer, the nurse will clamp and disconnect the tubing from the Versatile 1 unit. The Versatile 1 unit is NOT to be sent with the patient.