V.A.C. Therapy Patient Guide

Important Information Patients: It is important that you discuss any potential benefits and risks of a specific therapy with your doctor to decide whether it is right for you. Please consult your treating medical professional regarding specific questions and important information related to 3M™ V.A.C.® Therapy System indications, contraindications, warnings, precautions and operation. Rx only.

Table of Contents Wound Healing is a Process... 2 How Long Will it Take to Heal My Wound?... 2 What is 3M™ V.A.C.® Therapy?... 2 Four Part Advanced Wound Therapy System...3 There is Only One 3M™ V.A.C.® Therapy...4 3M™ V.A.C.® Dressing Placement...4 3M™ V.A.C.® Dressing Changes...5 Frequently Asked Questions about 3M™ V.A.C.® Therapy...6

Therapy

Wound healing is a process Proper wound care management is important to heal your wound and your doctor may prescribe the 3M™ V.A.C.® Therapy System as part of your wound care treatment plan. A clinician is responsible for directing the use of the V.A.C.® Therapy System including application and periodic dressing changes.

How long will it take to heal my wound? The length of time to heal a wound is different for every patient. Factors such as age over 65, nutrition, obesity, smoking, infection, malignancy, steroid use, pulmonary disease and other underlying health conditions have been shown to significantly affect the time it takes for a wound to heal.1,2 Your clinician will discuss when and why 3M™ V.A.C.® Therapy may begin and end.

What is 3M™ V.A.C.® Therapy? V.A.C.® Therapy is a medical device system that creates an environment that promotes wound healing by delivering negative pressure (a vacuum) to the wound through a proprietary dressing and therapy unit. Unlike gauze bandages that merely cover a wound, V.A.C.® Therapy works to help the wound healing process by:

• Providing a moist wound healing environment • Drawing wound edges together • Removing wound fluids and infectious materials

• Promoting formation of the connective tissue in healing wounds

• Potentially reducing the need for daily dressing changes

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The 3M™ V.A.C.® Therapy System is an advanced wound therapy system consisting of five parts: 1. The 3M™ V.A.C.® Therapy Unit that delivers negative pressure 2. A disposable canister that collects wound fluids and infectious materials 3. Sterile plastic tubing with 3M™ SensaT.R.A.C.™ Technology that allows the therapy unit to sense the amount of negative pressure delivered to the wound 4. Special foam dressings (3M™ V.A.C.® Granufoam™ Dressing and 3M™ V.A.C. Whitefoam™ Dressings) that are placed in the wound 5. A clear adhesive drape (3M™ V.A.C.® Drape or 3M™ Dermatac™ Drape) that covers the foam dressing(s)

1. 3M™ V.A.C.® Therapy Unit Note: Device illustration representative only. Your doctor may prescribe a different V.A.C.® Therapy Unit.

2. 3M™ V.A.C.® Canister 3. 3M™ V.A.C.® Tubing with 3M™ SensaT.R.A.C.™ Pad

3. 3M™ V.A.C.® Granufoam™ Dressing 4. 3M™ V.A.C.® Drape or 3M™ Dermatac™ Drape 3

Therapy

There is only one 3M™ V.A.C.® Therapy V.A.C.® Therapy has set the standard for negative pressure wound therapy (NPWT) with more than 10 million wounds managed worldwide.1 Evidence supporting V.A.C.® Therapy includes over:

• 90 randomized controlled trials2 • 1,800 peer-reviewed articles2 • 1,900 published journal articles2 Many clinicians, hospitals, skilled nursing facilities, wound care centers and home health agencies use or prescribe the advanced 3M™ V.A.C.® Therapy System to help their patients heal.

Introducing 3M™ Dermatac™ Drape, the new NPWT drape available for dressing changes. Dermatac Drape is a hybrid drape made of acrylic and silicone that is strong enough to maintain a seal for V.A.C.® Therapy, yet gentle enough to help take the pain out of dressing changes.

3M™ V.A.C.® Dressing Placement The V.A.C.® Dressing goes on or inside a wound. One end of the tubing connects to the dressing. The other end connects to the canister that fits into the therapy unit. The wound area is sealed with the clear adhesive 3M™ V.A.C.® Drape or Dermatac Drape that helps maintain negative pressure over the wound.

Indications for Use The V.A.C.® Therapy System is an integrated wound management system for use in acute, extended and home care settings. It is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. It is indicated for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, venous insufficiency or pressure), flaps and grafts. The V.A.C.® Granufoam Silver™ Dressing is an effective barrier to bacterial penetration and may help reduce infection in the above wound types.

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When used on closed surgical incisions, it is intended to manage the environment of surgical incisions that continue to drain following sutured or staple closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

3M™ SensaT.R.A.C.™ Pad 3M™ V.A.C.® Drape or 3M™ Dermatac™ Drape 3M™ V.A.C.® Granufoam™ Dressing

3M™ V.A.C.® Dressing Changes The V.A.C.® Therapy System uses proprietary foam dressings (3M™ V.A.C.® Granufoam™ Dressing, 3M™ V.A.C. Granufoam Silver™ Dressing and/or 3M™ V.A.C. Whitefoam™ Dressing) with the therapy unit. Only V.A.C.® Dressings are to be used with the 3M™ V.A.C.® Therapy Units. Wounds managed with the V.A.C.® Therapy System should be monitored on a regular basis by your clinicians who are responsible for treatment.

• For a non-infected wound: V.A.C.® Dressings

should be changed every 48 to 72 hours, but no less than 3 times per week.

• For infected wounds: These wounds must be

monitored often and very closely. Infected wounds dressing changes may need to be changed more often than 48 to 72 hours. Dressing change intervals should be based on continuing evaluation of your wound condition by your clinician.

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 of V.A.C.® Therapy System Safety Information for additional information concerning Bleeding. V.A.C.® Therapy is contraindicated for patients with: 1) Malignancy in the wound. 2) Untreated osteomyelitis; Note: Refer to Warnings section of V.A.C.® Therapy System Safety Information for Osteomyelitis information. 3) Non-enteric and unexplored fistulas; 4) Necrotic tissue with eschar present. NOTE: After debridement of necrotic tissue and complete removal of eschar, V.A.C.® Therapy may be used. 5) Sensitivity to silver (V.A.C.® Granufoam Silver™ Dressing only). 5

Therapy

Do not place 3M™ V.A.C.® Dressings in contact with exposed blood vessels, anastomotic sites, organs, nerves. Please discuss and review this information and the device instructions for use with your clinician so you can fully understand the benefits and risks of 3M™ V.A.C.® Therapy.

Some frequently asked questions about 3M™ V.A.C.® Therapy 1. How does 3M™ V.A.C.® Therapy feel? Most patients describe V.A.C.® Therapy as a non-painful, mild pulling sensation that, in most cases, is not noticeable after a few minutes. Wound comfort may vary by individual. The wound may become tender or itch as it heals; this is usually a good sign. If itching or discomfort persists, please contact your doctor. 2. Can you move around while on 3M™ V.A.C.® Therapy?  our ability to move around depends on your Y condition, the wound location and type of therapy unit prescribed. The V.A.C.® Therapy System may be disconnected so you can take a shower. Therapy may not be off any longer than two hours per day. If therapy is off/interrupted for more than 2 hours, dressings will need to be changed. 3. What does the foam dressing look like when 3M™ V.A.C.® Therapy is working?  our doctor may prescribe a 3M™ V.A.C.® Granufoam™ Y Dressing, 3M™ V.A.C.® Granufoam Silver™ Dressing or 3M™ V.A.C. Whitefoam™ Dressing for your wound type. The V.A.C.® Granufoam™ Dressing and V.A.C.® Granufoam™ Silver™ Dressing will shrink down and wrinkle like a raisin when V.A.C.® Therapy is working. The V.A.C. Whitefoam Dressing may only have a few wrinkles.

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4. Does changing the 3M™ V.A.C.® Dressing hurt?  ome people do experience discomfort during S dressing changes depending on the wound type, location and patient condition. The discomfort is similar to other dressings and wound care treatments for the same wound type. 3M™ Dermatac™ Drape is kind and gentle to skin. The low tack adhesive allows for easier removal which may be helpful for patients with thin or sensitive skin. Your doctor or nurse can give you advice about pain relief. 5. Who should change my dressing? Usually a nurse from your doctor’s office, home health agency or wound care clinic trained in V.A.C.® Therapy, will change your dressing. 6. W  hen should I call my clinician when on 3M™ V.A.C.® Therapy? Immediately report to your clinician if you have any of these symptoms:

• Fever over 102° • Diarrhea • Headache • Sore throat • Confusion • Sick to your stomach or throwing up • Dizziness or feel faint when you stand up • Redness around the wound • Skin itches or rash present • Wound is sore, red or swollen • Pus or bad smell from the wound • Area in or around wound feels very warm • A sudden increase or a large amount of blood from wound in the tubing or canister

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Therapy

7. What happens if the 3M™ V.A.C.® Therapy System alarms? The V.A.C.® Therapy System is built with your safety in mind. The 3M™ V.A.C.® Therapy Unit has alarms that you can see and hear which will alert you to a potential problem. In most situations, the reason for the alarm is easily fixed. Refer to the documents that came with your therapy unit for information on alerts and alarms. If needed, call your clinicians or 3M for assistance. This is something your clinician can explain in more detail, so you are comfortable with this alarm system. 8. How noisy is the 3M™ V.A.C.® Therapy System?  ll of the V.A.C.® Therapy Systems are medical A devices with moving parts. Noise may seem louder at night when surrounding noise level is greatly decreased. The units are designed with software that helps to identify leaks at the wound site. When a leak is present, the unit may make a ramping noise and the unit will begin to alarm.  hen the seal has been fixed, the unit will W no longer alarm and the ramping noise will stop. The unit may also have a gurgling sound when clearing air from the system. 9. Who should I contact if I have further questions?  ontact your clinician with any medical questions. C In case of an emergency immediately call your local emergency contact number (i.e. 911).

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For questions about V.A.C.® Therapy System operation, call 800-275-4524.

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Ask your doctor about 3M™ V.A.C.® Therapy This is a summary of some basic information about V.A.C.® Therapy. It is not intended to be a guide to product use, operation and placement. Please read the 3M™ V.A.C.® Therapy System Quick Reference Guide and 3M™ V.A.C.® Therapy System User Manual for specific questions and important information about V.A.C.® Therapy System indications, contraindications, warnings, precautions and operation and discuss this information with your clinician. Important information: Patients: It is important that you discuss any potential benefits and risks of a specific therapy with your doctor to decide whether it is right for you. Please consult your treating medical professional regarding specific questions and important information related to V.A.C.® Therapy indications, contraindications, warnings, precautions and operation. Caution: Federal law restricts this device to sale/rental by or on the order of a physician. References: 1. Riou JP, Cohen JR, Johnson H Jr. Factors influencing wound dehiscence. Am J Surg. 1992 Mar;163(3):324-30. doi: 10.1016/0002-9610(92)90014-i. PMID: 1531739. 2. Abbas SM, Hill AG. Smoking is a major risk factor for wound dehiscence after midline abdominal incision; case-control study. ANZ J Surg. 2009 Apr;79(4):247-50. doi: 10.1111/j.1445-2197.2009.04854.x. PMID: 19432709. 3. K  CI Cumulative NPWT Wounds 2018. 4. 3M™ V.A.C.® Publications Report dated 19 April 2021.

NOTE: Specific indications, contraindications, warnings, precautions and safety information exist for these products and therapies. Please consult a clinician and product instructions for use prior to application. Rx only. © 2021 3M. All rights reserved. 3M and the other marks shown are marks and/or registered marks. Unauthorized use prohibited. 70-2011-8232-9 PRA-PM-US-03100 (05/21)

3M Company 2510 Conway Ave St. Paul, MN 55144 USA Phone Web

1-800-275-4524 (NPWT products) 1-800-228-3957 3M.com/medical