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1. 50 1A suppl C2 1 8 Kaplan M Banwell P Orgill DP Ivatury RR Demetriades D Moore FA Miller P Nicholas J Henry S Guidelines for the Management of the Open Abdomen WOUNDS 2005 Oct 17 Suppl 1 51524 Garner GB Ware DN Cocanour CS Duke JH McKinley BA Kozar RA Moore FA Vacuum assisted wound closure provides early fascial reapproximation in trauma patients with open abdomens The American Journal of Surgery 2001 Dec 182 6 630 8 Barker DE Kaufman HJ Vacuum Pack Technique of Temporary Abdominal Closure A 7 Year Experience with 112 Patients Presented at the 59th Annual Meeting ofthe American Association for the Surgery of Trauma September 16 18 1999 Boston Mass Brock WB Barker DE Temporary Closure of Open Abdominal Wounds The Vacuum Pack Presented at the 66th Annual Scientific Meeting of the Southeastern Congress Lake Buena Vista Florida February 6 10 1994 Sherck J Seiver A Covering the Open Abdomen A Better Technique Presented as a Poster at the 66th Annual Scientific Meeting and the Postgraduate Course Program Southeastern Surgical Congress Atlanta Georgia January 31 February 4 1998 CONTACT INFORMATION For questions regarding this product maintenance or additional information about KCI products and services please contact KCI or a KCI authorized representative or In the US call 1 800 275 4524 or visit www kcil com or www openabdomen com Outside the US visit www kci medical com MANU
2. ABThera SensaT R A C Curativo em Abd men Aberto Somente para uso com Terapia com Press o Negativa aplicadas pelos Sistemas de Terapia InfoV A C V A C ATS ou V A C UIta ABThera SensaT R A C A k Abdomen Pansumani Yaln zca InfoV A C V A C ATS ya da V A C UIta Tedavi Sistemleri taraf ndan sa lanan Negatif Basing Tedavisi ile kullan ma y neliktir ETTI EOUOG AVOIKT C KolAtaKfic xopac ABThera SensaT R A C M vo y a xenon ue ta ouotrjpaxa Oeparre ac apvnrtiknc r eongc InfoV A C V A C ATS kai V A C Ulta ABThera SensaT R A C Open Abdomen sidos k ytett v ksi vain InfoV A C V A C ATS tai V A C Ulta hoitoyksikoilla annettavan hoidon yhteydess ABThera Sensal R A C Forbinding for pent abdomen Bare for bruk med behandling med undertrykk med behandlingssystemene InfoV A C 5 V A C ATS eller V A C UIta From the Makers K of V A C Therapy ga INSTRUCTIONS FOR USE O ABThera SensaT R A C gt H A Bl h e ra TM Open Abdomen Dressing z r Active Abdominal Therapy Only for use with Negative Pressure Therapy e eo T provided by InfoV A C V A C ATS e e or V A C Ulta Therapy Units PRODUCT DESCRIPTION The ABThera SensaT R A C Open Abdomen Dressing when used with Negative Pressure Therapy provided by the InfoV A C V A C ATS and V A C Ulta Therapy Units provides an active temporary abdominal closure system designed to remove fluids
3. from the abdominal cavity and draw wound edges together helping to achieve primary fascial closure while protecting abdominal contents from external contaminates SAFETY INFORMATION IMPORTANT As with any prescription medical device failure to consult a physician and carefully read and follow all therapy unit and dressing instructions and safety information prior to each use may lead to improper product performance and the potential for serious or fatal injury Do not adjust therapy unit settings or perform therapy application without directions from or supervision by the clinical caregiver All disposable components of the ABThera SensaT R A C Open Abdomen Dressing are for single use only Re use of disposable components may result in wound contamination infection and or failure of the wound to heal INDICATIONS FOR USE The ABThera SensaT R A C Open Abdomen Dressing is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and or repeat abdominal entries are necessary The intended use of this dressing is in open abdominal wounds with exposed viscera including but not limited to abdominal compartment syndrome The intended care setting is a closely monitored area within the acute care hospital such as the ICU The abdominal dressing will most often be applied in the operating theater CONTRAINDICATIONS Never place exposed foam material directly in contact with exposed bowel o
4. BI a era INSTRUCTIONS FOR USE ABThera SensaT R A C Active Abdominal Therapy Open Abdomen Dressing Only for use with Negative Pressure Therapy provided by InfoV A C V A C ATS or V A C UIta Therapy Systems ABThera Sensal R A C Dressing f r offenes Abdomen Nur zur Verwendung mit Unterdrucktherapie der Therapiesysteme InfoV A C V A C ATS oder V A C UIta ABThera Sensal R A C Open Abdomen Dressing Alleen voor gebruik met Negative Pressure Therapy geleverd door InfoV A C V A C ATS of V A C Ulta Therapy systems Pansement pour abdomen ouvert ABThera Sensal R A C A utiliser uniquement avec une unit de th rapie par pression n gative InfoV A C V A C ATS ou V A C UIta ABThera SensaT R A C Medicazione per addome aperto esclusivamente per l uso con la terapia a pressione negativa erogata dai sistemi terapeutici InfoV A C V A C ATS o V A C UIta Ap sito para Abdomen Abierto ABThera SensaT R A C Para uso exclusivo con Terapia de Presi n Negativa suministrada mediante Sistemas de Terapia InfoV A C V A C ATS o V A C Ulta ABThera Sensal R A C Forbinding til det bne abdomen Kun til brug med Negative Pressure Therapy fra InfoV A C V A C ATS eller V A C Ulta Terapisystemer ABThera Sensal R A C F rband f r ppna buksar Far endast anv ndas i behandling med negativt tryck genom behandlingssystemen InfoV A C V A C ATS eller V A C Ulta
5. FACTURER INFORMATION m C C 0473 KCI USA Inc San Antonio TX 78219 USA 1 800 275 4524 www kcil com EC REP KCI Medical Products UK Ltd Wimborne Dorset BH21 75H United Kingdom www kci medical com All trademarks designated herein are property of KCI Licensing Inc its affiliates and or licensors 1 2013
6. acement of any temporary abdominal closure does not eliminate the possibility of elevation in intra abdominal pressure IAP When using Negative Pressure Therapy IAP monitoring for clinical or diagnostic signs and symptoms of elevated IAP should continue as indicated by patient condition and in accordance with institutional clinical practice or guidelines If intra abdominal hypertension IAH or abdominal compartment syndrome ACS is observed or suspected note intra abdominal pressures and turn off power to the Negative Pressure Therapy Unit discontinuing negative pressure After full expansion of the perforated foam obtain a new intra abdominal pressure measurement If IAH ACS persists without negative pressure discontinue the use of Negative Pressure Therapy and address the underlying condition as medically indicated Use of Visceral Protective Layer When using Negative Pressure Therapy ensure that the Visceral Protective Layer completely covers all exposed viscera and completely separates the viscera from contact with the abdominal wall Place the Visceral Protective Layer over the omentum or exposed internal organs and carefully tuck it between the abdominal wall and internal organs making sure the Visceral Protective Layer completely separates the abdominal wall from the internal organs Adhesions and Fistula Development Formation of adhesions of the viscera to the abdominal wall may reduce the likelihood of fascial reapproximation
7. ackaging and insert into the therapy unit until it locks into place NOTE Abdominal wounds often have copious drainage Consider using the 1000 cc mL canister Ensure an adequate supply of canisters is readily available CAUTION Consider the size and the weight of the patient patient condition wound type monitoring capability and care setting when using the 1000 cc ml canister NOTE f the canister is not fully engaged the therapy unit will alarm 2 Connect Sensal R A C Pad tubing to canister tubing and ensure clamp on each tube is open Fig 18 Position clamps away from patient 3 Turn on power to the therapy unit and select 125 mmHg continuous mode therapy setting for efficient fluid removal rates Negative pressure therapy settings below 125 mmHg are not recommended CAUTION Do not use intermittent therapy Dynamic Pressure Control DPC with the ABThera SensaT R A C Open Abdomen Dressing 4 Initiate therapy Assess dressing to ensure integrity of seal The dressing should collapse and have a wrinkled appearance There should be no hissing sounds If there is any evidence of non integrity check drape and SensaT R A C Pad seals tubing connections and canister insertion and ensure clamps are open Secure excess tubing to prevent inadvertent tension on tubing which may disrupt the seal Monitor Fluid Output The dressing is designed to efficiently remove fluid from the abdominal compartment and to evenly
8. and increase the risk of fistula development which is acommon complication in patients with exposed viscera Infection Infected abdominal wounds should be monitored closely and may require more frequent dressing changes than non infected wounds dependent upon factors such as patient condition wound condition and treatment goals Refer to dressing application instructions for details regarding dressing change frequency Dressing Placement Always use a dressing from a sterile package that has not been opened or damaged Do not force any dressing component into the wound as this may damage underlying tissue Dressing Removal The dressing components are not bioabsorbable Always remove all dressing components from the abdomen at every dressing change Keep Negative Pressure On Never leave the dressing in place without active negative pressure for more than two hours If negative pressure is off for more than two hours change dressing as shown in the dressing application instructions Either apply a new dressing from an unopened sterile package and restart negative pressure or apply an alternative dressing Defibrillation Remove adhesive drape from area of defibrillation to prevent inhibition of electrical energy transmission Acrylic Adhesive The drape has an acrylic adhesive coating which may present a risk of adverse reaction in patients who are allergic or hypersensitive to acrylic adhesives If a patient has a known allergy or hypers
9. distribute negative pressure When treating patients with the Negative Pressure Therapy Unit the volume of exudate in the canister and tubing should be frequently examined Bleeding Patients with abdominal wounds must be closely monitored for bleeding as these wounds may contain hidden blood vessels which may not be readily apparent If sudden or increased bleeding is observed in the dressing tubing or canister immediately discontinue Negative Pressure Therapy take appropriate measures to stop bleeding and contact the physician Negative Pressure Therapy is not designed to prevent minimize or stop bleeding Refer to WARNINGS Bleeding section ALARM RESOLUTIONS Alltherapy unit alarms should be addressed in a timely manner Refer to the therapy unit user manual for complete information on alarm resolutions In case of a leak alarm patch leak source with additional drape to ensure integrity of seal CAUTION Due to the highly exudative nature of abdominal wounds Negative Pressure Therapy should be interrupted only for wound care and dressing change Interruption of therapy can result in loss of seal integrity DRESSING CHANGES Dressing changes should occur every 24 to 72 hours or more frequently based upon a continuing evaluation of wound condition and patient presentation Consider more frequent dressing changes in the presence of infection or abdominal contamination Refer to Application Setting section under WARNINGS Wheneve
10. e pad or insert the tubing into the foam dressing This may occlude the tubing and cause the Negative Pressure Therapy Unit to alarm and could injure underlying viscera 1 Choose pad application site Give particular consideration to fluid flow and tubing position to allow for optimal flow and avoid placement over bony protuberances or within creases in the tissue 2 Pinch drape and cut a 2 5 cm hole not a slit through the drape Fig 14 It is not necessary to cut into the foam NOTE Cuta hole rather than a slit as a slit may self seal during therapy 3 Apply pad which has a central disc and a surrounding outer adhesive skirt Gently remove both backing layers 1 and 2 to expose adhesive Fig 15 Place pad opening in central disc directly over hole in drape Fig 16 Apply gentle pressure on the central disc and outer skirt to ensure complete adhesion of the pad 4 Pull back on blue tab to remove pad stabilization layer Fig 17 Dressing application is complete V A C NEGATIVE PRESSURE THERAPY APPLICATION NOTE Only for use with Negative Pressure Therapy provided by InfoV A C VA C ATS and V A C Ulta Negative Pressure Therapy Units Refer to the therapy unit user manual for complete instructions for use NOTE SensaT R A C Pad tubing is not compatible with hospital vacuum systems WARNING Review all Negative Pressure Therapy System Safety Information before initiating therapy 1 Remove canister from p
11. ensitivity to such adhesives do not use the dressing If any signs of allergic reaction or hypersensitivity develop such as redness swelling rash urticaria or significant pruritus discontinue use and ensure appropriate emergency medical treatment If bronchospasm or more serious signs of allergic reaction appear remove dressing and ensure appropriate emergency medical intervention as indicated Magnetic Resonance Imaging MRI Therapy Unit The Negative Pressure Therapy Unit is MR unsafe Do not take the device into the MR environment Magnetic Resonance Imaging MRI ABThera SensaT R A C Open Abdomen Dressing The dressing can remain on the patient with minimal risk in an MR environment assuming that use of Negative Pressure Therapy is not interrupted for more than two hours please refer to Keep Negative Pressure On section Hyperbaric Oxygen Therapy HBO Do not take the Negative Pressure Therapy Unit into a hyperbaric oxygen chamber The Negative Pressure Therapy Unit is not designed for this environment and should be considered a fire hazard After disconnecting the Negative Pressure Therapy Unit either i replace the dressing with another HBO compatible material during the hyperbaric treatment or ii cover the unclamped end of the SensaT R A C Pad tubing with moist cotton gauze For HBO therapy the tubing must not be clamped Never leave a dressing in place without active negative pressure for more than two hours
12. nce This may lead to loss of system efficacy or harm to the patient Bleeding Patients with abdominal wounds must be closely monitored for bleeding as these wounds may contain hidden blood vessels which may not be readily apparent If sudden or increased bleeding is observed in the dressing tubing or canister immediately discontinue Negative Pressure Therapy take appropriate measures to stop bleeding and contact the physician Negative Pressure Therapy is not designed to prevent minimize or stop bleeding Hemostasis must be achieved prior to dressing placement The following conditions may increase the risk of potentially fatal bleeding e Suturing and or anastomoses Trauma Radiation Inadequate wound hemostasis Non sutured hemostatic agents for example bone wax absorbable gelatin sponge or spray wound sealant applied in the abdomen may if disrupted increase the risk of bleeding Protect against dislodging such agents Infection in the abdominal wound may weaken visceral organs and associated vasculature which may increase susceptibility to bleeding Use of anticoagulants or platelet aggregation inhibitors Bone fragments or sharp edges could puncture vessels or abdominal organs Beware of possible shifting in the relative position of tissues vessels or organs within the abdominal wound that might increase the possibility of contact with sharp edges Intra abdominal Pressure Monitoring Laparotomy with the pl
13. onsidered for certain small or elderly patients who are at risk of fluid depletion or dehydration Monitor fluid output including the volume of exudate in both the tubing and canister This therapy has the potential to remove and collect large volumes of fluid Tubing volume approximately 25 mL from Sensal R A C Pad to canister Spinal Cord Injury In the event a patient experiences autonomic dysreflexia sudden changes in blood pressure or heart rate in response to stimulation of the sympathetic nervous system discontinue Negative Pressure TOherapy to help minimize sensory stimulation Bradycardia lo minimize the risk of bradycardia the dressing must not be placed in proximity to the vagus nerve Enteric Fistula or Leak When treating an open abdomen where enteric fistulas are present clinicians should consider the potential for abdominal contamination if effluent is not appropriately isolated or managed 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 drape hydrocolloid or other transparent film e Multiple layers of the drape may decrease the moisture vapor transmission rate which may increase the risk of maceration Ifany signs of irritation or sensitivity to the drape foam or SensaT R A C Pad tubing appear discontinue use and consult a physician To avoid trauma to the
14. periwound skin do not pull or stretch the drape over the foam dressing during drape application If there are any questions regarding the proper placement or usage of the ABThera SensaT R A C Open Abdomen Dressing please contact your local KCI clinical representative DRESSING APPLICATION ABThera SensaT R A C OPEN ABDOMEN DRESSING COMPONENTS CED a CED Foam 2 Sensal R A C Visceral Protective Pad 1 Layer 1 WOUND PREPARATION WARNING Review all ABThera SensaT R A C Open Abdomen Dressing Safety Information before beginning wound preparation Ensure adequate hemostasis has been achieved prior to dressing placement refer to Bleeding section under WARNINGS 1 Sharp edges or bone fragments must be eliminated from wound area or covered refer to Bleeding section under WARNINGS 2 Irrigate abdominal wound and cleanse periwound skin as indicated 3 Clean and dry periwound tissue 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 drape hydrocolloid or other transparent film VISCERAL PROTECTIVE LAYER APPLICATION The Visceral Protective Layer is fenestrated to allow for active fluid removal when negative pressure is applied and is designed to allow application of this layer directly over omentum or exposed internal organs WARNING The foam in the Visceral Protective Layer i
15. please refer to the Keep Negative Pressure On section Application Setting Dressing applications and changes should be performed under strict sterile conditions in the surgical suite If dressing change is performed outside the surgical suite it must be performed in an environment equipped to address the onset of critical complications refer to WARNINGS section and where strict aseptic technique can be utilized 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 fluids is likely Intra abdominal Packing When using intra abdominal packing with Negative Pressure Therapy packing material may be drier than anticipated Evaluate packing material prior to removal and rehydrate if necessary to prevent adherence or damage to adjacent structures Monitor Fluid Output he dressing is designed to efficiently remove fluid from the abdominal compartment and to evenly distribute negative pressure When treating patients with Negative Pressure Therapy the volume of exudate in the canister and tubing should be frequently examined Patient Size and Weight The size and weight of the patient should be considered when prescribing Negative Pressure Therapy Initial lower negative pressure should be c
16. r the dressing is changed always replace all dressing components with components from an unopened sterile package DRESSING REMOVAL Remove and discard previous dressing per institution protocol Completely inspect wound including paracolic gutters to ensure all pieces of dressing components have been removed If intra abdominal packing is present packing material may be drier than anticipated Evaluate packing material prior to removal and rehydrate if necessary to prevent adherence or damage to adjacent structures WARNING Refer to Dressing Removal section under WARNINGS EXPLANATION OF SYMBOLS USED Me Manufacturer Date of Manufacture Do not use if package is damaged or open Single use only S Y Consult instructions for use Content information EN Contains Phthalates E DEHP EC REP Authorized Representative in the European Community Method of sterilization Radiation Conforms with the Medical Device C Directive 93 42 EEC and has been subject to the conformity procedures Use by laid down in the council directive CAUTION Federal US law restricts Rx Only this device to sale rental by or on the order of a physician Keep dry T 2013 KCI Licensing Inc All Rights Reserved 370553 Rev D REFERENCE LIST References available on request Please contact KCI at 1 800 275 4524 in the US Kaplan M Managing the open abdomen Ostomy Wound Management 2004 Jan
17. rgans blood vessels or nerves Protect vital structures with the Visceral Protective Layer at all times during therapy Patients with open abdominal wounds containing non enteric unexplored fistulas should not be treated with the ABThera SensaT R A C Open Abdomen Dressing Management of the open abdomen has been documented in case reports and consensus panel literature Please refer to the References List section of this document Not for use with Instillation Therapy Although it is accepted medical practice to flush a contaminated open abdominal cavity with saline or other medical solutions the ABThera Sensal R A C Open Abdomen Dressing was not designed for this purpose and KCI has no studies to support its safe and effective use with instillation therapy Potential risks of instillation into the open abdomen include Instillation of fluid in the abdomen without sufficient fluid recovery may lead to abdominal compartment syndrome Instillation of fluids in the abdomen that are untested for safety and efficacy with this application could lead to severe hollow viscus and solid organ damage Instillation of unwarmed fluid in large quantities may lead to hypothermia Only Use the SensaT R A C Pad Substitution with any other tubing alteration of the SensaT R A C Pad or breach of the prescribed SensaT R A C Pad application for the purpose of instilling fluids into the open abdomen is not recommended under any circumsta
18. rofile 2 Gently place perforated foam into wound cavity over the Visceral Protective Layer Fig 8 Ensure that perforated foam does not go below the level of the abdominal incision or wound Do not force foam into any area of the wound NOTE Ensure foam to foam contact for even distribution of negative pressure NOTE A ways note the total number of pieces of foam used and document on the drape and in the patient s chart DRAPE APPLICATION 1 Holding the drape partially pull back one side of layer 1 to expose adhesive Fig 9 Be sure to hold layer 1 flap back to prevent re adherence to drape 2 Place the drape adhesive side down to cover foam and intact skin ensuring drape covers at least an 8 10 cm border of intact periwound tissue Fig 10 Use any excess drape to seal difficult areas if needed NOTE 7o avoid trauma to the periwound skin do not pull or stretch the drape over the foam dressing Minimize wrinkles as they may be a source of negative pressure leaks refer to PRECAUTIONS Protect Periwound Skin section 3 Remove remaining tab 1 backing material and pat around drape to ensure an occlusive seal 4 Remove green striped stabilization layer 2 Fig 11 5 Remove perforated blue handling tabs from drape Fig 12 NOTE When using multiple pieces of drape ensure that the edges of the drape overlap in order to achieve a seal Fig 13 SENSAT R A C PAD APPLICATION NOTE Do not cut off th
19. s encapsulated for patient safety Protect vital structures with Visceral Protective Layer at all times during therapy Never place exposed foam material directly in contact with exposed bowel organs blood vessels or nerves 1 Remove contents from inner pouch and unfold the Visceral Protective Layer in a sterile field Either side of the Visceral Protective Layer may be placed on the omentum or viscera 2 Gently place Visceral Protective Layer over the open abdominal cavity Fig 1 3 Determine the orientation of the dressing for the specific application If Visceral Protective Layer will be placed around tubes drains or the falciform ligament cut only between the foam extensions Fig 2 Do not cut near or through foam extensions Orient the Visceral Protective Layer accordingly before cutting 4 Size the Visceral Protective Layer by folding or cutting as described in the following sections Folding Visceral Protective Layer to Size 1 Hold dressing by the edge and slightly lift Slowly lower dressing into the paracolic gutter using the other hand to gently and evenly work the dressing down Fig 3 Fold any excess Visceral Protective Layer up and over onto itself 2 Continue placing Visceral Protective Layer between abdominal wall and internal organs Fig 4 throughout the abdominal compartment The goal is to ensure full coverage of all viscera Cutting Visceral Protective Layer to Size 1 Cut Visceral Protecti
20. ve Layer away from wound through center of large foam squares using sterile scissors Fig 5A Do not cut through narrow connecting tabs between the large foam squares 2 Pinch the remaining half of the foam square and its connecting tab and pull The foam and tab will separate at the next square Fig 5B This will ensure that edges of Visceral Protective Layer cover exposed foam edge Fig 5C and foam cannot contact organs see WARNING above 3 Document number of foam extensions removed and that each piece has been properly disposed of away from wound cavity CAUTION Do not tear the foam over the wound as fragments may fall into the wound Rub or trim foam away from wound removing any fragments to ensure loose particles will not fall into or be left in the wound upon dressing removal PERFORATED FOAM APPLICATION Fig 6 The perforated foam Fig 6 provided with the ABThera SensaT R A C Open Abdomen Dressing is intended to Transfer negative pressure from the Negative Pressure Therapy Unit to the Visceral Protective Layer to promote active fluid removal Provide medial tension upon foam collapse to help maintain fascial domain 1 Tear or cut perforated foam to needed size as shown below Fig 7 The foam should fit directly over the Visceral Protective Layer and be in contact with wound edges Do not allow foam to contact intact skin One or both pieces ofthe provided perforated foam can be used depending on the wound p

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