PICO 7 Clinical guidelines and evidence... · It is a well-established principle that wounds are...

PICO 7

Clinical guidelines Supporting healthcareprofessionals for over 150 years

Table of contents

Introduction 3Wound bed preparation 4Optimization of NPWT in open wounds 5Wound assessment 6Optimization of incisional NPWT 7

PICO™ 8 Description 9Indications for use 9Contraindications 10Warnings 11Precautions 12General guidance 14Product application 15Dressing change 18Optimization of therapy application 19Use with fillers and wound contact layers 20 General use 21

Appendix 22 Is the wound PICO appropriate 22 Wound selection guidance: closed incisions 24 Frequently asked questions and answers 26 Ordering information 28References 28

Introduction — 3

Smith & Nephew has an extensive portfolio of wound care products and therapies that cover all major aspects of managing a wide range of wound types. It is a well-established principle that wounds are managed across a continuum of healing and require different therapies at each step in the continuum. Smith & Nephew offers negative pressure wound therapy (NPWT) as part of a complete range of wound care products to use along a patient’s journey towards healing. The key to deciding which product to use at each stage of the continuum is to identify the barriers to healing along with a treatment goal to combat those issues.1,2

NPWT is widely adopted as a standard treatment for patients with both acute and chronic wounds.3 A variety of formats are now available, and, as the wound progresses along the continuum, a switch from one format to another may be the most appropriate course. NPWT has been shown to be cost effective when used appropriately.4,5 Knowledge of when NPWT is most appropriate and when alternative therapies may be more appropriate is vitally important to maintain the efficient use of resources while not negatively affecting wound outcomes.3,6,7

Negative pressure wound therapy involves the application of controlled levels of sub-atmospheric (negative) pressure to a wound or closed surgical incision. The systems described in these guidelines consist of a disposable suction pump to generate negative pressure and a variety of wound dressing kits to deliver the therapy to the wound site. The benefits of NPWT for open wounds in progression towards wound healing go well beyond drainage management. Studies have shown that NPWT improves granulation tissue formation, may decrease bacterial burden, protects from the outside environment, promotes moisture balance within the wound bed, and may decrease the frequency of dressing changes.3

Additionally NPWT is now a widely accepted therapy for use on closed surgical incisions. Incisional NPWT (iNPWT) is the process of applying sub-atmospheric pressure to a closed surgical incision with the primary objective of preventing surgical site complications (SSCs). These may include complications such as seroma, surgical site infection, dehiscense, and prolonged drainage. iNPWT has multiple mechanisms of action that can help improve the speed, strength and quality of incisional wound closure.8 iNPWT synergistically delivers a multi-modal mechanism of action by protecting the incision from external contamination, reducing the lateral tension to the incision, reducing edema, improving perfusion, and it may reduce the likelihood of seroma and hematoma formations.9-13

4 — Introduction

T issue nonviable or deficient Infection or inflammation Moisture imbalance E dge of wound non-advancing or underminedBarrier Defective matrix and cell debris

High bacterial counts or prolonged inflammation

Desiccation or excess fluid

Non-migrating keratinocytes

Non-responsive wound cells

Intervention Debridement AntimicrobialsDressings

Compression

Biologicals agents

Adjunct therapies

Debridement

OutcomeRestore wound base and ECM proteins

Low bacterial counts and controlled inflammation

Restore cell migration, maceration avoided

Stimulate keratinocyte migration

Wound bed preparation

Wound bed preparation has been defined as the process of removing the barriers to healing. Removal of these barriers is thought to allow the wound repair process to progress.1,2

The Tissue, Infection, Moisture and Edge (epithelial margin) “TIME” scheme is a useful way of identifying and removing barriers to healing.

Wound bed preparation represents a combination of both scientific knowledge and practical skill; its application can help correct abnormalities in acute and chronic wounds and stimulate or progress the healing process.1 To optimize the use of negative pressure wound therapy, it is essential that clinicians ensure wound bed preparation is achieved prior to, during and after therapy.7

TIME principles of wound bed preparation2

Introduction — 5

Debride wound Effective debridement may:• Reveal extent of tissue damage• Reduce biochemical imbalance, senescent cells16

• Reduce bacterial burden16

• Reduce odor• Optimize healing potential16

Consequences of ineffective debridement are:• Potential for delayed healing• Potential for infection• Physical barrier preventing accurate assessment• Reduced patient Quality of Life (QoL)• Psychological aspects

Optimize wound closure – mechanisms of action3• Remove exudate• Assist in wound contraction• Stimulate granulation tissue• Protect from outside contaminants• Increase vascular perfusion

• May reduce wound bioburden• Remodel connective tissue matrix• Encourage maturation of epithelial cells• Maintain a moist wound environment

Know when to stop or change treatment• Established goal of therapy has been met 3,14

• No improvement or reduction in wound volume has been documented consecutively for 2 weeks14

• Individual patient characteristics and wound considerations may vary clinical decisions in regards towhether to continue or discontinue NPWT14

Use NPWT

Prepare the wound environment

Know when to stop or change treatment

Optimal healing/cost-effective wound care

Optimization of NPWT in open woundsThe effective use of NPWT relies on thorough assessment of the patient, the wound,and development of a plan for how the wound might be closed. When to debrideand when to start and stop NPWT are keys to an effective treatment plan.14,15

Foam Gauze

Optimal closure/cost-effective wound care

6 — Introduction

Wound assessmentNPWT treatment depends heavily upon the quality of the clinical wound assessment. The wound should have a detailed assessment at the initiation of the NPWT treatment regime and with every dressing change thereafter. The following areas should be addressed with every wound assessment:

Wound size: length, width, depth• NPWT has the ability to assist with removal of interstitial fluid and sloughy necrosis.17,18 With the

removal of the space filling materials, the volume of the wound may increase slightly. This will likelyhappen within the first few dressing changes, especially if the wound is in the inflammatory phaseof wound healing.

Granulation tissue: amount and description• Healthy granulation tissue should be beefy red and not bleed easily. No trauma should occur to the

granulation tissue with dressing removal. A non-adherent dressing or a contact layer may be usedto reduce pain or where the risk of tissue ingrowth is present.3

Epithelialization: amount and description• Epithelialization is thin and often noted to be shiny or silver in appearance and may be hard to see.

The new cells are very fragile. If undermining is present, it is important to fill the undermined areaswith gauze or foam to prevent the edges from rolling under.

Necrotic tissue: type and amount• The use of NPWT in wounds with necrotic tissue with eschar present is contraindicated.

• Necrotic tissue is devitalized tissue and often appears black or brown, hard and dry. Soft or boggynecrotic tissue should be assessed for infection.

• NPWT, along with the autolytic environment established by the Transparent Film, may result in adecrease in necrotic slough.17,19

Slough • Slough is necrotic or devitalized tissue that is yellow in appearance and can be dry or moist.

Exudate: type, amount and consistency• Assess wound exudate for type, amount, color and consistency. Evaluate the wound exudate for

consistent characteristics with the wound type and the anticipated exudate. Significant changes inexudate warrant a reassessment of the wound.

Odor: present/absent, description• It is important to note that body fluids that have been contained in a sealed system for an extended

period of time may likely have an unpleasant odor. This odor is not a direct indication of woundinfection. Remove dressing and cleanse wound per facility protocol. If odor persists, assess forwoundinfection, and if required, treat and increase frequency of dressing changes until odor is undercontrol. The use of an antimicrobial wound contact layer may be used to reduce bacterial burden.20

General therapy considerations

Introduction — 7

Optimization of NPWT in closed incisions The effective use of iNPWT relies on thorough assessment of the patient, the incision, and the preparation of the surgical site.

• Determine if patient has risk factors for SSCs that may warrant the use of iNPWT

• Ensure skin surrounding incision is clean and dry

• If using a skin protectant, allow it to thouroughly dry

• Determine length of time for iNPWT therapy

Optimize wound closure – mechanisms of action for iNPWT • Protect the incision from external contaminents9

• Reduce lateral tension to the incision10

• May help reduce edema11

• May help improve perfusion11

• May help reduce seroma and hematoma formations12,13

Know when to stop or change treatment • Established goal of therapy has been met (ex. Incision is intact with no drainage and the epithelium

is closed).

• Incision does not respond to iNPWT, consider additional applications or other treatment modalities.

Helps hold the incisions edges together and helps reduce tension across the incision10

May help improve perfusion11

May help reduce edema11

May help reduce seroma and hematoma fluid collections12,13

Protects the incision from external contamination9

PICO™ 7 Single Use NegativePressure Wound Therapy System

PICO 7 Single Use Negative Pressure Wound Therapy System — 9

DescriptionPICO™ 7 consists of a pump and sterile dressing(s). The PICO 7 pump maintains negative pressure wound therapy at -80 mmHg (nominal) to the wound surface. Exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.15

The PICO 7 dressing kit is intended to be used for up to 7 days on low exuding wounds. For moderate exuding wounds the system is intended to be used for up to 4 days. For 7 days use on moderate exuding wounds additional dressings will be required (available for purchase separately).

Low exuding wounds are considered to be up to 0.6g of liquid exudate/2cm of wound area/24 hours. Moderate exuding wounds are considered to be up to 1.1g of liquid exudate/2cm of wound area/24 hours. 1g of exudate is approximately equal to 1ml of exudate.

The frequency of dressing changes can be affected by multiple factors such as wound type, wound size, rate or volume of exudate, orientation or environmental conditions. Additional dressings are available to purchase separately, as required.

Indications for usePICO 7 is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials. Examples of appropriate wound types include:

• Chronic

• Acute

• Traumatic

• Subacute and dehisced wounds

• Partial-thickness burns

• Ulcers (such as diabetic or pressure)

• Flaps and grafts

• Closed surgical incisions

PICO Single Use Negative Pressure Wound Therapy System is suitable for use both in a hospital and homecare setting.

10 — PICO 7 Single Use Negative Pressure Wound Therapy System

ContraindicationsThe use of PICO™ 7 is contraindicated in the presence of:

• Patients with malignancy in the wound bed or margins of the wound (except in palliative care toenhance quality of life).

• Previously confirmed and untreated osteomyelitis.

• Non-enteric and unexplored fistulas.

• Necrotic tissue with eschar present.

• Exposed arteries, veins, nerves or organs.

• Exposed anastomotic sites.

PICO 7 should not be used for the purpose of:

• Emergency airway aspiration.

• Pleural, mediastinal or chest tube drainage.

• Surgical suction.

Important Information


Warnings

2. Certain patients are at high risk of bleeding complications which, if uncontrolled, couldpotentially be fatal. Patients must be closely monitored for bleeding. If sudden or increasedbleeding is observed, immediately discontinue therapy, leave dressing in place, take appropriatemeasures to stop bleeding and seek immediate medical assistance.

3. Hemostasis must be achieved before applying the dressing, although the use of anticoagulants doesnot deem a patient inappropriate for treatment with PICO 7. Patients suffering from difficult hemostasisor who are receiving anticoagulant therapy have an increased risk of bleeding. During therapy, avoidusing hemostatic products that may increase the risk of bleeding, if disrupted. Frequent assessmentmust be maintained throughout the therapy.

4. At all times care should be taken to ensure that the pump and tubing does not:

− Lie in a position where it could cause pressure damage to the patient.

− Trail across the floor where it could present a trip hazard or become contaminated.

− Present a risk of strangulation or a tourniquet to patients.

− Rest on or pass over a source of heat.

− Become twisted or trapped under clothing or bandages so that the negative pressure is blocked.

5. Sharp edges or bone fragments in a wound must be covered or removed prior to using PICO 7 due torisk of puncturing organs or blood vessels while under negative pressure.

6. In the event that defibrillation is required, disconnect the pump from the dressing prior to defibrillation.Remove the dressing if it is positioned in a location that will interfere with defibrillation.

7. MR Unsafe. The PICO 7 pump is not MRI compatible. Remove the PICO 7 pump from the dressingbefore entering the MRI suite. Do not bring PICO 7 into the MRI scan room.The device presents a projectile hazard.

Important Information

Warnings


Precautions1. Precautions should be taken in the following types of patients who are at high risk of

bleeding complications:

− Receiving anticoagulant therapy or platelet aggregation inhibitors or actively bleeding.

− Having weakened or friable blood vessels or organs in or around the wound as a resultof, but not limited to; anastomoses, infection, trauma or radiation.

− Suffering from difficult wound hemostasis.

− Untreated for malnutrition.

− Noncompliant or combative.

− Suffering from wounds in close proximity to blood vessels or delicate fascia.

2. If pain, reddening, odor, sensitization or a sudden change in the volume or color of woundfluid occurs during use, contact your healthcare professional.

3. Where PICO 7 is used to bolster skin grafts, it is important to visually inspect the systemregularly, especially in the first week of treatment to ensure that negative pressure woundtherapy is continually applied and a seal is maintained.

4. Where PICO 7 dressings are used on infected wounds, more frequent dressing changes maybe required. Regular monitoring of the wound should be maintained to check for signs ofinfection.

5. If deemed clinically appropriate, care should be taken that the application of a circumferentialdressing or the use of negative pressure wound therapy on ischemic limbs does notcompromise circulation.

6. PICO 7 does not contain audible alarms. The pump should be carried so that it is accessible and the patient/healthcare professional can check the status routinely.

7. Although PICO 7 dressings can be used under clothing/bedding, it is important thatocclusive materials e.g. film dressings, are not applied over the pad area of the dressing asthis will impair the intended evaporation of moisture through its outer layer.

8. The PICO 7 dressing should not be covered by rigid immobilization devices or casts whichmight apply excessive pressure and cause tissue injury at the wound site, especially wherethe tubing enters the dressing.

9. Prolonged placement of rigid or opaque materials over the PICO 7 dressing may prevent theregular inspection and assessment of the wound, and disrupt scheduled orrequired dressing changes.

10. Where PICO 7 dressings are used on patients with fragile skin, a skin protectant such asNO-STING SKIN-PREP™ should be used on areas of skin where fixation strips are to be applied.Inappropriate use or repeated application of fixation strips may otherwise result in skin stripping.

8. PICO™ 7 has not been studied on pediatric patients. Patient size and weight should beconsidered when prescribing this therapy.

9. PICO 7 is unsuitable for use in areas where there is danger of explosion (eg hyperbaricoxygen unit).

10. The system contains small parts which could represent a choking hazard for youngchildren. Keep out of the reach of children.

11. PICO 7 is not suitable for use in the presence of flammable anesthetic mixture with oxygenor nitrous oxide.

12. PICO 7 dressings should only be applied, changed or removed by a healthcare professional.

13. Each PICO 7 dressing (including Multisite) must be used to dress one wound only.


11. Do not use PICO™ 7 dressings with oil-based products such as petrolatum as it may compromise establishing an effective seal.

12. The use of negative pressure wound therapy presents a risk of tissue ingrowth into foam when this is used as a wound filler. When using foam filler with PICO 7, tissue ingrowth may be reduced by using a non-adherent wound contact layer or by increasing the frequency of dressing changes.

13. PICO 7 may be used in conjunction with surgical drains provided the dressing is not placed over tubing where it exits the skin. Any surgical drain should be routed under the skin away from the edge of the dressing and function independently of the PICO 7 System.

14. The pump must be protected from sources of fluid e.g. from incontinence or spillages. Discontinue PICO 7 use if fluid ingress is observed.

15. When showering the PICO 7 pump should be disconnected from the dressing. While disconnected, ensure the end of the tubing attached to the dressing is facing down so that water does not enter the tube.

16. Do not take the pump apart.

17. The PICO 7 dressing should only be used with PICO 7 pumps.

18. Do not alter or cut tubing configuration or pull on the tubing or soft port.

19. Do not cut the PICO 7 dressing pad as this may lead to loss of negative pressure wound therapy application.

20. Always ensure that the PICO 7 dressing is positioned centrally over the wound. The soft port should be positioned uppermost on intact skin and not extend over the wound so that the risk of fluid collecting around the soft port and potentially blocking the therapy is minimized.

21. The potential for electromagnetic interference in all environments cannot be eliminated. Use caution if PICO 7 is near electronic equipment such as RFID (Radio Frequency Identification) readers, anti-theft equipment or metal detectors.

22. CT scans and x-ray have the potential to interfere with some out of the x-ray or scanner range. If the pump has been taken into the CT scan or x-ray range, check that the system is functioning correctly following the procedure.

23. The PICO 7 system is single use only. Use of any part of this system on more than one patient may result in cross contamination that may lead to infection.

24. High temperatures and humidity may reduce wear times of PICO 7 dressings.

25. The PICO 7 system is intended for use in both a hospital and homecare setting. The system can also be used in aircraft, train and boat transportation. Special care must be taken regarding pump positioning when in close proximity to other people (see magnet warning).

26. During transport there is a potential for radio frequency interference that could affect PICO 7 performance. If the PICO 7 pump malfunctions, replace batteries. If not corrected, contact your healthcare professional to replace the system.

27. When applying dressings next to one another, ensure the dressing borders do not overlap.

Adverse Reactions Excessive bleeding is a serious risk associated with the application of suction to wounds which may result in death or serious injury. Careful patient selection, in view of the above stated contraindications, warnings and precautions is essential. Carefully monitor the wound and dressing for any evidence of a change in the blood loss status of the patient. Notify the healthcare professional of any sudden or abrupt changes in the volume or the color of exudate.


Instructions for useGuidance on wound suitability

PICO 7™ dressings should be used on wounds which fit comfortably within the area of the pad, observing precautions on soft port positioning (on intact skin and not extending over the wound). PICO 7 Multisite dressings are designed to enhance conformability when dressing awkward anatomical areas. PICO 7 dressings (including Multisite) must be used to dress one wound only.

As a guide:

Depth – Wounds greater than 0.5cm (1/4 in.) in depth are likely to require a foam or gauze negative pressure wound therapy filler to ensure adequate treatment of all the wound surfaces. Wounds treated with the larger dressing sizes of the PICO 7 system should generally be no more than 2cm (4/5 in.) in depth.

Exudate – PICO 7 is intended for use on wounds where the level of exudate is low (up to 0.6g of liquid exudate/2cm of wound area/24 hours) to moderate (up to 1.1g of liquid exudate/2cm of wound area/24 hours). 1g of exudate is approximately equal to 1ml of exudate. When used on a moderately exuding wound, the size of the wound should generally be no more than 25% of the dressing pad area.

Management of open wounds (see wound selection guide section for further information)

• Intended for use on wounds with low to moderate levels of exudate.

• Not intended for use on complex wounds with extensive undermining or tunneling. Complexity of thewound refers to the characteristics of the wound and not specific to wound etiology.

• When used on a moderately exuding wound, the size of the wound should generally be no more than25% of the dressing pad area.

Incision management – closed surgical incisions (see wound selection guide section for further information.) Surgical procedures – NPWT is indicated for patients considered to be at risk for surgical site complications.

• Choose dressing size slightly larger than incision or wound length to allow the port to be positionedabove or lateral to the incision to minimize exposure of port to wound drainage.

• If excessive exudate is present and/or large volume incisional drainage is anticipated, consider the useof traditional NPWT until fluid noted is low to moderate and then transition the patient to PICO 7.

• NO-STING SKIN-PREP™ may be used on intact skin surrounding the incision. It is important to allow theNO-STING PREP to dry completely before dressing application.


•

Split thickness skin graft (STSG)/Skin substitutes

PICO™ 7 may be utilized over STSG/skin substitutes.• Choose dressing size slightly larger than graft to allow the port to be positioned above the graft to

minimize exposure of port to wound drainage.

• Generally a non-adherent layer is applied over the graft prior to PICO 7 application.

• Depending on the contour of the graft site additional filler may be utilized to stabilize the graft.

• PICO 7 has a continuous set pressure of nominal -80mmHg.

• Monitor dressing and pump functionality frequently.

Product application1. The dressing should only be applied by a healthcare professional. Remove

any excess hair to ensure close approximation of the dressing to the wound.If necessary, irrigate the wound with sterile saline and pat the wound dry.

2. Using a clean technique, peel off the central release handle and place thedressing centrally over the wound to reduce the chance of wound fluidcoming into contact with the port. The port should be uppermost from thewound (depending on the patient’s primary position), placed on intact skinand not extending over the wound to prevent fluid pooling around the portand blocking the negative pressure. Remove the other handle and smooththe dressing around the wound to prevent creasing. Reposition if requiredto ensure border is not creased.

3. Once the dressing is in place, remove the pump and the batteries from the tray.Insert the batteries. Replace the cover. Following this all four indicators shouldilluminate for 3 seconds.

4. Join the pump to the dressing by twisting together the tubing connectors. Pressthe orange button to start the application of negative pressure. The green lightwill start to flash.

Depending on the size of the wound, the pump should take up to 65 secondsto establish negative ressure wound therapy.

If after 65 seconds the system has not established negative pressure woundtherapy, the amber air leak light will illuminate. To troubleshoot refer to section.

5. If using NO-STING SKIN-PREP™ prior to application of the fixation strips(see Precautions), wipe the area surrounding the dressing and allow skin to dry.

6. Apply the fixation strips to each of the four sides of the dressing. Remove topcarrier on the strip after each one has been applied. These strips maintain /theseal over the wear time of the dressing. In awkward areas, it may be useful toapply the strips to help achieve a seal prior to switching on the pump. Placeeach strip so that it overlaps the dressing border by approximately 1cm (2/5 in.).Do not apply fixation strips directly over white PICO pad. Ensure tubing is nottwisted or trapped between clothing.

Please note that if at any time the fixation strips are removed, the dressingshould also be replaced.

PICO 7 does come with extra extension tubing if needed.


The pump is working to achieve NPWT but has not reached the intended pressure.

Wait up to 65 seconds. Assess whether NPWT has been established.

Green “OK” and orange “leak” indicators flash

Pump status and troubleshooting

Display/indicator status Possible cause Comments/troubleshooting

System is functioning properly but the batteries are low.

Replace the batteries and press the orange button to restart therapy.

Green “OK” and orange “battery low” indicators flash

Orange “leak” indicator flashesA high air leak has been detected. NPWT is not being applied.

Note: the pump will automatically try to restart NPWT after 1 hour.

Smooth down the dressing and strips to remove any creases. Press the orange button to restart therapy. If the air leak remains, the orange ‘leak’ indicator will flash again after approximately 60 seconds. Ensure that the tube connectors have been twisted together securely. Press the orange button to restart NPWT. The green OK indicator and orange air leak indicator will start to flash together (indicates pump working to re-establish NPWT). Depending on the size of the wound, the pump should take up to 65 seconds to re-establish NPWT. If the air leak remains, the orange “leak” indicator will flash again after approximately 65 seconds. If the air leak persists, contact healthcare professional.

System is functioning properly.No issues.

The pump may be heard running occasionally as it maintains the negative pressure. This is normal.

Green “OK” indicator flashes

All indicators offThe pump is in standby.

The pump has completed its course of NPWT.

The batteries have depleted.

NPWT is paused. Press the orange button to restart NPWT.

Pressing the orange button will not restart NPWT. Healthcare professional to apply new pump and dressing if further NPWT is required.

If the pump has not yet completed its course of NPWT, replace the batteries.

Pump status and troubleshootingPICO™ 7 has visual indicators to let the user know when there is an issue. PICO 7 does not contain audible alerts. The pump should be carried so that it is accessible and the patient/healthcare professional can check the status routinely in case there is a fault or in case of damage.

PICO™ 7 Single Use Negative Pressure Wound Therapy System — 17

Display/indicator status Possible cause Comments/troubleshooting

Orange “leak” and orange “battery low” indicators flash A high air leak has been detected

and the batteries are low. NPWT is not being applied.


Resolve the air leak according to instructions detailed in the brochure. Also replace the batteries and press the orange button to restart therapy.

Orange “dressing full” indicator flashes Dressing is saturated or filter is blocked.

NPWT is not being applied.


Healthcare professional to replace the dressing with a new one and press the orange button to restart NPWT.

Orange “dressing full” and orange “battery low” indicators Dressing is saturated or filter is blocked

and the batteries are low. NPWT is not being applied.


Healthcare professional to replace the dressing with a new one. Also replace the batteries and press the orange button to restart therapy.

All indicators solidly illuminatedA pump error has been detected. The pump can no longer apply NPWT.

Healthcare professional to apply a new pump and dressing.

Advanced Wound ManagementSmith & Nephew, Inc. Customer Care Center

USA Fort Worth, TX 76109 1 800 876-1261

T 727 392-1261

www.smith-nephew.com

F 727 392-6914

™Trademark of Smith & Nephew©2018 Smith & NephewPCBE3-14182-0818

Supporting healthcare professionals for over 150 years

www.possiblewithpico.com

For detailed product information, includingindications for use, contraindications, effects, precautions, warnings, and important safetyinformation, please always consult product’s Instructions for Use (IFU) prior to use.

For more information on electromagneticimmunity and electromagneticemissions see: www.mypico.com or ask your Smith &Nephew representative for a hardcopy.


Dressing change Dressings should only be changed by a healthcare professional.

1. Dressings should only be changed in line with standard wound management guidelines, typically every 3-4 days. At the healthcare professional’s discretion a PICO™ 7 dressing may be left in place for up to 7 days. The orange dressing full indicator on the pump will flash if it detects a full dressing or blocked filter. More frequent dressing changes may be required depending on the level of exudate, condition of the dressing, wound type/ size, orientation of the dressing, environmental considerations or other patient considerations; e.g. when PICO 7 is used on infected wounds. Additional dressings for PICO 7 are available for purchase separately.

Dressing requires change - absorbent area is full

Dressing properly positioned and is acceptable to be left in place

Dressing requires change - port may block with fluid

2. Inspect the PICO dressing regularly. If the dressing appears ready for changing (see diagram above), press the orange button and disconnect the dressing from the pump. The fixation strips should be stretched away from the skin and the dressing lifted at one corner and peeled back until it has been fully removed. Apply another dressing, connect to the pump and press the orange button to reinitiate the therapy.

3. Based on dressing change frequency, further dressings may be required.

4. The PICO 7 dressing should be disposed of as clinical waste.

5. The pump life ends and it automatically stops functioning at 7 days (all the indicators will turn off at this point). The batteries should be removed from the pump; and both batteries and pump disposed of according to local regulations.

6. For additional information on disposal requirements see: www.mypico.com or speak to your Smith & Nephew representative.

Is the exudate level low to moderate?PICO 7 is suitable for incisions with low to moderate exudate.

Low Medium High

Dressing change indicator



Dressing requires change - port may block�with�fluid

Go

7. Apply�the�fixation�strips�to�each� of the four sides of the dressing.

8. The device has a 7 day life and the dressing may be left in place for up to 7 days, depending on the level of exudate.

9. When�a�filler�is�used,�the�filler� and the PICO 7 Dressing should be changed 2 to 3 times a week.


Low Medium High





Go





Low Medium High





Go





Optimization of therapy application Ensuring a good seal – assessing for leaks

• After application, firmly run your fingers around the perimeter of the dressing pad and silicone border.

• Assess for wrinkling and smooth down wrinkles in the silicone border prior to the application adhesive anchoring strips.

• If placing PICO™ 7 in areas of complexity (i.e., skin folds, digits, contours), use of a gel strip or other wound care products may be used to create a tight seal. Adhesive strips may be needed to seal difficult areas.

• When placing PICO 7 in close proximity to drains, isolate the drains using gel strip or other wound care supplies.

• Ensure that the connector between the pump and dressing are securely and tightly attached.

Protecting intact skin and minimizing the risk of skin blistering

1. Position dressing tubing port above the wound towards patient’s head.

2. Position dressing over wound, incision, or graft placing pad area down first.

3. Starting at the middle gently smooth silicone border to periwound area and work towards ends. Avoid applying any tension to border during application. If concerned about applying tension, may lift up and reapply silicone border to release any possible tension.

4. Connect to PICO 7 pump and ensure air tight seal, may reposition to minimize creases and/or leaks.

5. Once seal is achieved, apply anchoring strips – avoid using any tension during application. To prevent blistering of skin, NO-STING SKIN PREP™ may be used under adhesive strips. Always allow NO-STING SKIN PREP to dry completely prior to dressing application.

Closed surgical incision management

• When applying over a curved area such as an elbow or knee, flex the joint 15-30 degrees to prevent tension on the skin and allow for range of motion.

• To aid in application, snip or cut the silcone boarder up to but not into the pad to allow for contouring of the dressing in difficult areas or when external hardware is present.


Use with fillers and wound contact layers The PICO™ 7 System is compatible with standard gauze and foam fillers used in traditional NPWT where this is clinically appropriate – for example on a defect wound. When a filler is used, the filler and the PICO 7 dressing should be changed 2 to 3 times a week, according to local clinical protocol and manufacturer’s instructions. Gauze should be moistened with saline or sterile water prior to application and loosely fill to the surface of the wound. Foam should be cut to fit within the margins of the wound bed. Avoid over packing of wound fillers.

PICO may be used over the top of a non-adherent layer if required, for example over a skin graft.

On infected wounds or wounds at risk of infection, ACTICOAT™ Flex Silver-Coated Antimicrobial Dressings may be used under PICO.

14

Use with fillers and wound contact layersThe PICO™ System is compatible with standard gauze and foam fillers used in traditional NPWT where this is clinically appropriate – for example on a defect wound. When a filler is used, the filler and the PICO dressing should be changed 2 to 3 times a week, according to local clinical protocol and manufacturer’s instructions. Gauze should loosely fill to the surface of the wound. Avoid over packing of wound fillers.



Wound fillers

Considerations PICO tNPWT

Anticipated wound drainage Low – moderate < 300cc > 300cc

Contour of wound bed Minimal undermining or tunneling

Complex wound contour, significant undermining/tunneling

Wound filler May be used with or without filler depending on surface area and contour

Requires wound filler

2CM

2CM

PICO able to conform to wound with larger surface area – no filler required

PICO not able to conform to wound with small surface area – filler required

ACTICOAT Flex Silver-Coated Antimicrobial Dressing

Gauze filler Foam fillerGauze filler Foam filler ACTICOAT Flex Silver-Coated

Antimicrobial Dressing

Wound fillers



Contour of wound bed Minimal undermining ortunneling

Complex wound contour,significant undermining/tunneling

Wound fillerMay be used with orwithout filler depending onsurface area and contour


14




Wound fillers







2CM

2CM




Gauze filler Foam filler



14




Wound fillers







2CM

2CM




Gauze filler Foam fillerACTICOAT Flex may be kept on for 3 days in combination with NPWT. The products featured herein have different indications and study populations. Smith & Nephew makes no representations or claims of any kind related to increased clinical efficacy in using the products in combination. When PICO is used on an infected wound more frequent dressing changes may be required. Regular monitoring of the wound should be maintained to check for signs of infection. ACTICOAT Flex 3 is not intended to provide sole treatment for infected wounds. ACTICOAT Flex 3 may be used on infected wounds which are being managed per local clinical protocol. For detailed product information, including indications for use,contraindications, effects, precautions and warnings, please consult the product’s Instructions for Use (IFU) prior to use.

The use of negative pressure presents a risk of tissue ingrowth into foam when this is used as a wound filler. When using foam filler with PICO, tissue ingrowth may be reduced by using a wound contact layer or by increasing the frequency of dressing changes.


General use Showering and bathing

Light showering is permissible; however, the pump should be disconnected (see Precautions) and placed in a safe location where it will not get wet. The dressing should not be exposed to a direct spray or submerged in water. Ensure the end of the tubing attached to the dressing is facing down, or covered, so that water does not enter the top of the tube.

Cleaning

Adherence to clinical directives concerning hygiene is of prime importance. The pump may be wiped clean with a damp cloth using soapy water or a weak disinfectant solution.

Appendix — 23 22 — Appendix

Is the wound PICO™ appropriate?

Not PICO appropriate

Exudate levelsStep 1

Low Moderate 300ml

Does the wound have low to moderate levels of exudate?

Continue to Step 2 YesYes

No

Not PICO appropriate

Does the wound fit under 1 of the 10 PICO Dressings?

Wound sizeStep 2

Continue to Step 3

No

Yes

Recommendation: Choosing a dressing size that is slightly larger than the wound allows the benefits of negative pressure to extend to the periwound area

Appendix

Appendix — 23

Is the wound PICO™ appropriate?

Continue to Step 4, prior to application

Wound depthStep 3

Begin application

No

Note: NPWT requires direct contact with the wound bed. Prior to application, assess the wound to determine depth and if a filler would be required

Does the PICO™ system conform to the wound bed?

Yes

Wound bed depth 0.5cm in depth are likely to require a foam or gauze NPWT filler. Wounds >2cm in depth should generally not be treated with PICO dressings

Wear instructions:

• At the healthcare professional’s discretion, a PICO dressing may be left in place for up to 7 days, depending on level of exudate • When a filler is used, the filler and the PICO Dressing should be changed 2 to 3 times a week, according to the local clinical protocol and manufacturer’s instructions

Foam should be changed at least 3 times per week and gauze at least 2 times per week

FillersStep 4

10cm x 12.5cmFoam wound dressing

15cm x Antimicrobial gauze 17cm

Note: Gauze should loosely fill to the surface of the wound. Avoid over packing

Note: Please refer to the IFU for information regarding possible tissue ingrowth when using foam filler


Consideration 1: Is the patient high-risk for complications?21

Wound selection guidance: closed incisions

24


Does patient have BMI 35 or over?

The PICO™ System

The PICO SystemStandard dressing

• High BMI• Hypertension• Diabetes• Blood or hematological disorder• Autoimmune disease• Multiple Caesarean births• Pre-existing skin problems that will

impact healing• History of wound or healing problems• Emergent/urgent Caesarean births

Does patient have two or more high-risk factors?

No

YesNo


Yes

1st application

Day 6

Hernia1514

W O R L D U N I O N O F W O U N D H E A L I N G S O C I E T I E S

CONSENSUS DOCUMENT

Functions of a dressing applied to a closed surgical incision include acting as a barrier to external contamination, absorption of excessive leakage and providing a moist environment to aid healing[130]. Dressings containing antiseptic agents, such as silver, are being investigated for potential to prevent SSI[131].

Alternatives to conventional dressingsCyanoacrylate surgical wound adhesives perform the roles of surgical closure and wound sealant. However, a systematic review concluded that sutures are significantly better than adhesives at preventing dehiscence, and that there was no difference in SSI rate between incisions that had been sutured or glued[132].

NPWT is indicated for use on closed surgical incisions to aid healing in patients who are at increased risk of surgical site complications such as SSI, seroma, haematoma and dehiscence. There is a substantial body of evidence that incisional NPWT following a wide range of surgery types reduces the rates of surgical site complications[10,20,92,133-136]

(Appendix 9, pages 28–32).

As shown in Figure 2, the Expert Working Group proposes that NPWT is used in patients with closed surgical incisions who have intrinsic risk factors for surgical site complications or who have had a surgical procedure associated with higher incidence and/or higher consequence of surgical site complications. As research continues, new Level I evidence may become available that demonstrates beneficial effects of NPWT on surgical site complication rates in particular patient populations. If so, these patients should also be considered for incisional NPWT.

It may be clear pre-operatively that incisional NPWT is indicated for a patient. However, where this is not the case, a review following surgery and prior to application of a dressing

PREVENTING SURGICAL SITE COMPLICATIONS

Prevention of surgical site complications is complex because of the wide range and convoluted interactions of patient-related, environmental and surgical factors that may be involved. Risk factors may occur at multiple points during the pre-operative, operative and post-operative phases of surgery.

Since 2009, the WHO Surgical Safety Checklist (Appendix 5, page 24) has been used and adapted in many countries worldwide with the aim of improving surgical outcomes and reducing surgical mortality[71].

A prospective international multicentre cohort study found that introduction of the checklist was associated with significant reductions in mortality, and rates of any complication and SSI[117]. However, difficulties in replicating these results, and research showing that the checklists are not always used properly, have highlighted the complexity of the operating room environment and the importance of carefully planned implementation that includes gaining acceptance and support[24,121-123].

Interventions to reduce the risk of surgical site complicationsA wide range of interventions may help to reduce the risk of surgical site complications. Published recommendations about which interventions should be used tend to focus on those intended to reduce the incidence of SSI[30,68,72,73,124].

Efforts to reduce SSI, whether at local or national level, often include a limited number of selected interventions that are grouped together in a ‘care bundle’ to aid implementation[125] (Box 7). Compliance to the care bundle is often a feature of audit to monitor the impact of a bundle on SSI rates.

The challenges of constructing a care bundle include ensuring that the interventions selected are evidence based and feasible within the healthcare organisation[127], and that using the bundle does not distract from established good practice[128].

However, at present, risk stratification for surgical site complications and the impact of interventions in different patient groups are not sufficiently understood for a tailored, patient-centred approach. As a result, bundles are often used for all patients regardless of level of risk for surgical site complications. Ideally, interventions to reduce the risk of surgical site complications should be tailored and used according to an individual patient’s level of risk.

General pre-, intra- and post-operative interventions identified by the Expert Working Group as important for reduction of surgical site complications are summarised in Appendices 6–8 (pages 25–27). When constructing a bundle for a particular type of surgery or procedure, interventions specific to that surgery or procedure that reduce rates of surgical site complications effectively should also be considered. The strategy for implementation of an intervention or bundle is as important as the intervention or bundle itself.

Post-operative care of closed surgical incisionsThe aim of post-operative care of closed surgical incisions is to allow the wound to heal rapidly, without complications, and with the best functional and aesthetic results.Despite lack of definitive evidence that applying a dressing to a closed incision reduces the evidence of SSI[129], it is common practice and is advocated in SSI prevention guidelines[72].

Box 7 | Definition of a care bundle[126]

A care bundle is a structured way of improving the processes of care and patient outcomes: a small, straightforward set of evidence-based practices – generally three to five – that, when performed collectively and reliably, have been proven toimprove patient outcomes

ROLE OF NPWT IN CLOSED

SURGICAL INCISION MANAGEMENT

Patient with closed surgical incision

YES

YES

YES

NO

NO

NO

Standard post-operative dressing

Major patient-related factorsDoes the patient have any of the following major patient-related factors for surgical site complications:

n BMI≥40 kg/m2 or ≤18 kg/m2?n Uncontrolled insulin-dependent diabetes mellitus?

n Renal dialysis?

Apply NPWT to the closed surgical incision under aseptic conditions and before the patient leaves the operating room

High incidence/high consequence procedureHas the patient undergone surgery that has a higher incidence and/or higher consequence of surgical site complications?

Other risk factorsDoes the patient have 2 or more other patient-related or procedure-specific major or moderate risk factors for surgical site complications?

Figure 2 | Proposed role of NPWT in closed surgical incision management for the prevention of incisional complications

WUWHS_SI_consensus_FINALR1.indd 12-13 04/08/2016 12:24

24


Does patient have BMI 35 or over?

The PICO™ System

The PICO SystemStandard dressing

• High BMI• Hypertension• Diabetes• Blood or hematological disorder• Autoimmune disease• Multiple Caesarean births• Pre-existing skin problems that will

impact healing• History of wound or healing problems• Emergent/urgent Caesarean births

Does patient have two or more high-risk factors?

No

YesNo


Yes

1st application

Day 6

Hernia

Individual Results May Vary

Appendix — 25

Consideration 2: Which PICO™ Dressing size best fits the incision?

Dressing Dressing size

Multisite small 15cm x 20cm

Multisite large 20cm x 25cm

10cm x 20cm

10cm x 30cm

10cm x 40cm

15cm x 15cm

15cm x 20cm

15cm x 30cm

20cm x 20cm

25cm x 25cm

Consumables

Foam dressing filler

Gauze dressing filler

ACTICOAT™ Flex 7


Frequently asked questions and answers What is the suction pressure of your machine or the range of pressure that the machine achieves?PICO™ 7, operates at continuous negative pressure of -80mmHg.

Is the pressure pre-set?The pressure is pre-set on the PICO 7 System and it operates at continuous negative pressure of -80mmHg.

Can it be changed?The pressure cannot be changed on the PICO 7 System.

Is there an Intermittent feature and when should I use it?The PICO 7 System does not have an Intermittent feature. If intermittent therapy in clinically necessary consider using tNPWT.

Should I change the canister only when the canister full alarm is initiated?

The PICO 7 System is canister-free. Traditional NPWT may be the best option to manage wound fluid that is expected to exceed greater than 300cc in a week.

Is there a one-way valve to prevent fluid from coming back through the tubing towards the patient?The PICO 7 System has a filter that prevents fluid from coming back through the tubing toward the patient.

How long does the battery last?The PICO 7 System runs on two AA batteries that can be changed out if required, but should not be necessary. It is indicated for use up to 7 days, at which time the system is disposable.

How much does the machine weigh? (How portable is it?)PICO 7 is less than 4.2oz, and is small enough to easily fit in a pocket, like a smart phone.

What is the interface with the wound?The PICO 7 System employs a proprietary dressing technology that manages exudate, through a process of absorption and evaporation, eliminating the need for canisters.15

How often do you recommend changing the dressing?The PICO 7 System may be left in place for up to 7 days, depending on level of exudate and clinical judgment. If a wound filler is used with PICO, refer to filler guidelines. ACTICOAT FLEX 3 and ACTICOAT FLEX 7 are only approved for use with NPWT for up to 3 days.

Appendix — 27

Can you “Y” wounds together and if so how many?PICO™ 7 dressings cannot currently be Y-connected.

How do you handle exposed tendon or bone?Exposed tendons and bone should be covered with natural tissue or a non-adherent dressing layer prior to applying the NPWT dressing.

Do you have any special recommendations for high bioburden or infection?If available, we recommend the use of Smith & Nephew ACTICOAT™ Flex as a wound contact layer for wounds with a high bioburden or infection. ACTICOAT Flex is compatible for use with gauze or foam NPWT interface materials. ACTICOAT Flex is also indicated for use with PICO 7. Wounds that are infected may require more frequent dressing changes. Wound bed preparation and debridement should be practiced prior to the application of NPWT. ACTICOAT FLEX 3 and ACTICOAT FLEX 7 are only approved for use with NPWT for up to 3 days.

Advanced Wound ManagementSmith & Nephew, Inc. Fort Worth, TX 76109 USA

www.smith-nephew.com

Customer Care Center 1-800-876-1261 T 727-392-1261F 727-392-6914 Supporting healthcare professionals for over 150 years

™Trademark of Smith & Nephew ©2019 Smith & Nephew PCCE65-14182-0319

Dressing Dressing size 2x dressing kit* 1x dressing kit** Fluid Management Packs***

Multisite small 15cm x 20cm

66022000 66022010 66022020

Multisite large 20cm x 25cm

66022001 66022011 66022021

10cm x 20cm 66022002 66022012 66022022

10cm x 30cm 66022003 66022013 66022023

10cm x 40cm 66022004 66022014 66022024

15cm x 15cm 66022005 66022015 66022025

15cm x 20cm 66022006 66022016 66022026

15cm x 30cm 66022007 66022017 66022027

20cm x 20cm 66022008 66022018 66022028

25cm x 25cm 66022009 66022019 66022029

Consumables Product code

Foam dressing filler 10cm x 12.5cm 66801692

Gauze dressing filler 15cm x 17cm 66801691

ACTICOAT™ Flex 7 1in x 24in 66800544

* 2 x dressing kit = 2 dressings + 1 pump; ** 1 x dressing kit = 1 dressing + 1 pump; *** Fluid Management Packs = 5 dressings only

PICO™ 7 Ordering information

References: 1. Schultz GS, Sibbald RG, Falanga V, Ayello E a, Dowsett C, Harding K, et al., Wound bed preparation: a systematic approach to wound management. Wound Repair Regen. 2003 Mar;11 Suppl 1(Figure 1):S1–28. 2. Leaper DJ, Schultz G, Carville K, Fletcher J, Swanson T, Drake R. Extending the TIME concept: what have we learned in the past 10 years?(*). Int Wound J. 2012 Dec;9 Suppl 2:1–19. 3. Birke-Sorensen H, Malmsjo M, Rome P, Hudson D, Krug E, Berg L, et al., Evidence-based recommendations for Negative Pressure Wound Therapy: Treatment variables (pressure levels, wound filler and contact layer) - Steps towards an international consensus. J Plast Reconstr Aesthet Surg. 2011 Sep;64 Suppl:S1–16. 4. Apelqvist J, Armstrong DG, Lavery L a, Boulton AJM. Resource utilization and economic costs of care based on a randomized trial of vacuum-assisted closure therapy in the treatment of diabetic foot wounds. Am J Surg [Internet]. 2008;195(6):782–8. 5. Braakenburg A, Obdeijn MC, Feitz R, van Rooij I a LM, van Griethuysen AJ, Klinkenbijl JHG. The clinical efficacy and cost effectiveness of the vacuum-assisted closure technique in the management of acute and chronic wounds: a randomized controlled trial. Plast Reconstr Surg. 2006 Aug;118(2):390–7; 6. Runkel N, Krug E, Berg L, Lee C, Hudson D, Birke-Sorensen H, Depoorter M, et al., Evidencebased recommendations for the use of Negative Pressure Wound Therapy in traumatic wounds and reconstructive surgery: steps towards an international consensus. Injury. 2011 Feb;42 Suppl 1:S1–12. 7. Vig S, Dowsett C, Berg L, Caravaggi C, Rome P, Birke-Sorensen H, et al., Evi-dence-based recommendations for the use of negative pressure wound therapy in chronic wounds: steps towards an international consensus. J Tissue Viability. 2011 Dec;20 Suppl 1:S1–18. 8. Gomoll A, Lin A, Harris M. Incisional Vacuum-Assisted Closure Therapy. J Orthop Trauma _ Volume 20, Number 10, November/December 2006. 9. Lumb H. Bacterial barrier testing (wet-wet) of PICO dressing with a 7 day test duration against S. marcescens. 10. Wilkes RP, Kilpad DV, Zhao Y, Kazala R, McNulty A. Closed incision management with negative pressure wound therapy (CIM): biomechanics. Surg Innov. 2012;19(1):67–75.11. Karlakki S, Brem M, Giannini S, Khanduja V, Stannard J, Martin R. Negative pressure wound therapy for management of the surgical incisions in orthopaedic surgery: A review of evidence and mecha-nisms for an emerging indication. Bone Joint Res. 2013;2(12):276–284. 12. Canonico S, Campitiello F, Della Corte A, et al. Therapeutic possibilities of portable NPWT. Initial multidisciplinary observations with the negative pressure therapy device. Acta Vulnol. 2012;10(2):57–66. 13. Selvaggi F, Pellino G, Sciaudone G, et al. New advances in negative pressure wound therapy (NPWT) for surgical wounds of patients affected with Crohn’s disease. Surg Technol Int. 2014;24:83–89. 14. Henderson V, Timmons J, Hurd T, Deroo K, Maloney S, Sabo S. NPWT in everyday practice Made Easy. Wounds Int. 2010;1(5):1–6. 15. Malmsjö M, Borgquist O. NPWT Settings and Dressing Choices Made Easy. Wounds Int. 2010;1(3):1–6. 16. Kamolz L-P, Wild T. Wound bed preparation: The impact of debridement and wound cleansing. Wound Med [Internet]. Elsevier B.V.; 2013 ;1:44–50. 17. Lorée S, Dompmartin a, Penven K, Harel D, Leroy D. Is Vacuum Assisted Closure a valid technique for debriding chronic leg ulcers? J Wound Care [Internet]. 2004 Jun;13(6):249–52. Available from: http://www.ncbi.nlm.nih.gov/pubmed/15214145 18. Young SR, Hampton S, Martin R. Non invasive assessment of negative pressure wound therapy using high frequency diagnostic ultrasound: oedema reduction and new tissue accumulation. Int Wound J [Internet]. 2013 Jun 4 [cited 2013 Jun 13];10:383–8. Available from: http://doi.wiley.com/10.1111/j.1742-481X.2012.00994.x 19. Bondokji S, Rangaswamy M, Reuter C, Farajalla Y, Mole T, Cockwill J, et al. Clinical efficacy of a new variant of a foam-based NWPT system. J Wound Care [Internet]. 2011 Feb [cited 2012 Jun 7];20(2):62, 64–7. Available from: http://www.ncbi.nlm.nih.gov/pubmed/21378681 20. Lumb H. Smith & Nephew Data on File 0810010 The antimicrobial activity of Acticoat and Acticoat Flex 3 while under negative pressure 21. World Union of Wound Healing Societies (WUWHS) Consensus Document. Closed surgical incision management: understanding the role of NPWT. Wound International, 2016.

Appendix — 28

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