Skin Substitutes For W Ound Care AHM
Skin Substitutes for Wound Care AHMClinical Indications Any 1 or more of the following products for wound care are considered medicallynecessary if the individual criteria are met Apligraf (graftskin) aculture-derived human skin equivalent (HSE) is consideredmedically necessary for 1 or more of the following indications: For use with standard diabetic foot ulcer care for the treatment of full-thicknessneuropathic diabetic foot ulcers of greater than three-weeks duration that havenot adequately responded to conventional ulcer therapy and which extendthrough the dermis but without tendon, muscle, capsule or bone exposure In conjunction with standard therapy to promote effective wound healing ofchronic, non-infected, partial and full-thickness venous stasis ulcers that havefailed conservative measures of greater than one-month duration using regulardressing changes and standard therapeutic compression Dermagraft, a human fibroblast-derived dermal substitute, is considered medicallynecessary for any 1 or more of the following [A] [B] Treatment of full-thickness diabetic foot ulcers greater than six-week durationthat extend through the dermis, but without tendon, muscle, joint capsule or boneexposure Treatment of wounds related to dystrophic epidermolysis bullosa Systemic Hyperbaric Oxygen Therapy (HBOT ) - Refer to the HyperbaricOxygen Therapy Guideline. TransCyte, made up of allogeneic human dermal fibroblasts, a biosynthetic dressing,is considered medically necessary for any 1 or more of the following Temporary wound covering for surgically excised full-thickness and deep partialthickness thermal burn wounds in persons who require such a covering beforeautograft placement Treatment of mid-dermal to indeterminate depth burn wounds that typicallyrequire debridement and that may be expected to heal without autografting Orcel, a bilayered cellular matrix, is considered medically necessary for any 1 ormore of the following Healing donor site wounds in burn victimsAC-AESKI082011 Page 1 of 105Copyright 2016No part of this document may be reproduced without permission
ActiveHealth ManagementMedical Management Guidelines Dystrophic epidermolysis bullosa undergoing hand reconstruction surgery toclose and heal wounds created by the surgery, including those at donor sites. Biobrane biosynthetic dressing is considered medically necessary for temporarycovering of a superficial partial-thickness burn wound. Integra Dermal Regeneration Template, Integra Bilayer Matrix WoundDressing, and Integra Meshed Bilayer Wound Matrix (collagenglycosaminoglycan copolymers) is considered medically necessary for the treatmentof individuals with severe burns where there is a limited amount of their own skin touse for autografts or they are too ill to have more wound sites created. Alloderm, acellular dermal tissue matrix, is considered medically necessary forbreast reconstructive surgery Artiss fibrin sealant is considered medically necessary for the treatment ofindividuals with severe burns Oasis Wound Matrix is considered medically necessary for treatment of difficult-toheal chronic venous or diabetic partial and full-thickness ulcers of the lower extremitythat have failed standard wound therapy of at least 4-weeks duration. Graftjacket Regenerative Tissue Matrix is considered medically necessary fortreatment of full-thickness diabetic foot ulcers greater than 3-week duration thatextend through the dermis, but without tendon, muscle, joint capsule or boneexposure. Epicel cultured epidermal autograft is considered medically necessary formembers who have deep dermal or full thickness burns comprising a total bodysurface area of greater than or equal to 30%. Note: Epicel may be used in conjunction with split-thickness autografts, or alonein persons for whom split-thickness autografts may not be an option due to theseverity and extent of their burns.Current role remains uncertain. Based on review of existing evidence, there are currentlyno clinical indications for this technology. See Inappropriate Uses for more detailedanalysis of the evidence base. The following substitutes are considered investigationalbecause there is inadequate evidence in the peer reviewed medical literature to supporttheir clinical effectiveness Examples include Allopatch for soft tissue augmentation and all other indications Alloskin Alloskin RT AlloSource cryopreserved human cadaver skin AmnioCare AmnioExCel AmnioFix AmniomatrixAC-AESKI082011 Page 2 of 105Copyright 2016No part of this document may be reproduced without permission
ActiveHealth ManagementMedical Management Guidelines AmnioMTMAmnioShieldAmniotic fluid injection for corneal wound healing and for prevention of adhesionsafter orthopedic surgeryAmniox (human embryonic membrane) for tarsel tunnel repair and all otherindicationsArtelon (poly[urethane urea] elastomer) for anterior cruciate ligament reconstruction,rotator cuff repair, trapezio-metacarpal joint osteoarthritis and all other indicationsArthres GraftRope for acromio-clavicular joint separation reconstructionArthroflex (FlexGraft)Autologous blood-derived products (e.g., autologous platelet-rich plasma, autologousplatelet gel, and autologous platelet-derived growth factors (e.g., Autologel, Procuren,and SafeBlood))Autologous fat for the treatment of scarsAxogen 2 nerve wrapAvotermin for improvement of skin scarringBioDfactor/BioDfence human amniotic allograftBiostat Biologx fibrin sealant for wound healing and all other indications;Biotape reinforcement matrix for soft tissue augmentation and all other indicationsCellerateRXCollaFixConexa reconstructive tissue matrixCorMatrix Patch for cardiac tissue repair and all other indicationsC-QUR biosynthetic meshCRXaCymetra injectable allograft for wound healingDermacellDermaClose RC continuous external tissue expander for facilitation of wound closureand all other indicationsDermagraft for chronic foot ulcer secondary to necrotizing fasciitisDermaMatrix for wound healing and other indications other than breastreconstructionDermaSpanDryFlex (human amnion allograft) for shoulder repair and all other indicationsDuraGen Plus dural regeneration matrix for surgical repair of soft tissue deficienciesand all other indicationsDuraSealDurepair Regeneration MatrixEndoformAC-AESKI082011 Page 3 of 105Copyright 2016No part of this document may be reproduced without permission
ActiveHealth ManagementMedical Management Guidelines ENDURAGenEpidexEpiFix amniotic membrane for indications other than ocular surface disordersEPIFLO transdermal continuous oxygen therapy for wound healingEquine-derived decellularized collagen products (e.g., OrthADAPT, Unite, and UniteBiomatrix)E-Z Derm for wound healing and all other indicationsEvicel fibrin sealant for repair of cerebrospinal fluid leakage and all other indicationsFlexHD acellular dermal matrix for wound healing; for FlexHD for breastreconstructionFloGraftGammagraft skin substitute for wound healing and all other indicationsGORE BIO-A Fistula PlugGrafix Core and Grafix PrimeGraftjacket express injectable allograft for wound healing and all other indicationsHyalomatrix (hMatrix)HydroFixInforceIntegra Neural Wrap for peripheral nerve repair and all other indicationsIntegra Wound Matrix and Integra Flowable Wound Matrix for the management ofwounds including partial and full-thickness wounds, pressure ulcers, venous ulcers,diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgicalwounds (e.g., donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric,wound dehiscence), trauma wounds (e.g., abrasions, lacerations, second-degree burns,skin tears) and draining wounds and all other indicationsLiquidGenMatridermMatriStem wound micromatrix powderMediHoneyMedeorMemodermMenaflex Collagen Meniscus ImplantMeso BioMatrixNeoform Dermis for wound healing; for NeoForm for breast reconstructionNeox 1KNeox 100NeuragenNeuraWrapNeuroflexAC-AESKI082011 Page 4 of 105Copyright 2016No part of this document may be reproduced without permission
ActiveHealth ManagementMedical Management Guidelines NeuroMatrix collagen nerve cuff for peripheral nerve repair and all other indicationsNeuroMend collagen nerve wrap for peripheral nerve repair and all other indicationsNuCel liquid wound coveringNuShield, NuShield Orthopaedics, and NuShield SpineOasis burn matrix for wound healing and all other indicationsOasis Tri-Layer MatrixOrthADAPT Bioimplant (type I collagen scaffold) for tendon repair and all otherindicationsOsseoGuardOvationPalinGen membrane for wound healingParietex Composite (PCO) Mesh for the treatment of genito-urinary (e.g., uterine orvaginal vault) prolapsePeri-Guard Repair PatchPeri-Strips Dry, and Peri-Strips Dry with Veritas Collagen MatrixPermacol Biologic Implant for soft tissue surgical repairs, including hernia repair,muscle flap reinforcement, rectal prolapse (including intussusception), rectocelerepair, abdominal wall defects, plastic and reconstructive surgery, complex abdominalwall repair and all other indicationsPorcine-derived decellularized collagen products (e.g., Collamend, Cuffpatch,Pelvicol, and Pelvisoft)Porcine-derived decellularized fetal skin products (e.g., Mediskin)Porcine-derived polypropylene composite wound dressing (e.g., Avaulta Plus)PriMatrix acellular dermal tissue matrix for wound healing and all other indicationsPromogranPromogranPTFE feltPuracolRadiofrequency stimulation devices (e.g., Provant Wound Closure System, MicroVasVascular Treatment System) for wound healingSeamguardSilver-coated wound dressings (e.g., Acticoat, Actisorb, and Silversorb) for woundhealing and all other indicationsSolana allograftSportMatrixSportMeshStrattice tissue matrix for wound healingSuprathelAC-AESKI082011 Page 5 of 105Copyright 2016No part of this document may be reproduced without permission
ActiveHealth ManagementMedical Management Guidelines SurgiMend for plastic and reconstructive surgery, muscle flap reinforcement, herniarepair, reinforcement of soft tissues repaired by sutures or suture anchors, duringtendon repair surgery (including reinforcement of the rotator cuff, patellar, Achilles,biceps, quadriceps, or other tendons), and all indications other than breastreconstruction; for SurgiMend for breast reconstructionSurgisis (including Surgisis AFP Anal Fistula Plug, Surgisis Gold Hernia RepairGrafts, and Surgisis Biodesign)TalymedTenoGlide tendon protector sheet (Tendon WrapTM tendon protector) for themanagement and protection of tendon injuries and all other indicationsTenSix (acellular dermal matrix) for tendon repair and all other indicationsTheraSkinTissueMend for the repair or reinforcement of soft tissues repaired by sutures orsuture anchors during tendon repair surgery, including reinforcement of the rotatorcuff, patellar, Achilles, biceps, quadriceps, or other tendons, and all other indicationsTornier BioFiber Absorbable Biological Scaffold, and Tornier Collagen CoatedBioFiber ScaffoldVaso ShieldVeritas collagen matrix for use as an implant in the surgical repair of soft tissuedeficiencies and all other indicationsVitagel surgical hemostat for wound healing and all other indications;X-RepairXCM BiologicXelmaXenMatriEvidence SummaryBackground Apligraf (Graftskin):In recent years, skin grafting has evolved from the initial autograft and allograftpreparations to biosynthetic and tissue-engineered human skin equivalents (HSE).Apligraf (graftskin) (Organogenesis, Canton, MA) is a living, cell-based, bilayered skinconstruct. Like human skin, Apligraf has 2 primary layers, including an outer, epidermallayer made of living human keratinocytes, the most common cell type of the humanepidermis, to replicate the structure of the human epidermis. The human keratinocytesand fibrobasts are derived from neonatal forsekins. The dermal layer of Apligraf consistsAC-AESKI082011 Page 6 of 105Copyright 2016No part of this document may be reproduced without permission
ActiveHealth ManagementMedical Management Guidelines of living human fibroblasts and bovine type 1 collagen, the most common cell type in thehuman dermis, to create a dermis-like structure that produces additional matrix proteins.Proponents state that Apligraf stimulates the patient's own cells to regenerate tissue andheal the wound through mechanisms that include the secretion of growth factors,cytokines, and matrix proteins (Snyder, et al., 2012). Apligraf does not containmelanocytes, Landgerhans' cells, macrophages, lymphocytes, or tissue structures such asblood vessels, hair follicles, and sweat glands.Apligraf has has received a premarket approval (PMA) by the U.S. Food and DrugAdministration (FDA) in 1998 for treatment of venous leg ulcers and in 2001 fortreatment of diabetic ulcers. Apligraft has been approved for marketing under apremarket approval for "use with standard therapeutic compression for the treatment ofnoninfected partial and full-thickness skin ulcers due to venous insufficiency of greaterthan 1 month duration and which have not adequately responded to conventional ulcertherapy." Multiple supplemental approvals have been added since the first approval,including an indication for treating diabetic foot ulcers. Several of teh supplementsinvolve approval of the use of new human keratinocyte or fibroblast cell strains in themanufacture of Apligraf (Snyder, et al., 2012). Venous ulceration, a relatively commonmanifestation of venous hypertension, is often refractory to conservative treatment anddifficult to treat.Human skin equivalents appeared to promote wound healing in 3 ways: (i) apparent graft"take"; (ii) temporary wound closure (persistence of HSE with subsequent wound reepithelialization from wound margins); and (iii) stimulation of host healing withouttemporary persistence by acting as a biologic dressing.Apligraf was shown in clinical trials to heal even longstanding (greater than 1 year'sduration) venous leg ulcers more effectively and faster than compression therapy alone.The results of controlled, multi-center studies indicate that HSE interacts with thepatient's own cells, responds to individual wound characteristics, and promotes healing.Further studies are underway to investigate its use for the treatment of pressure sores,dermatological surgery wounds and burns. At this time, there is insufficient informationto extend coverage for the use of Apligraf in the treatment of these conditions.Dermagraft:Another product approved by the FDA for repair of diabetic foot ulcers is AdvancedBioHealing, Inc. (La Jolla, CA) Dermagraft, composed of cryopreserved human-derivedfibroblasts and collagen applied to a bioabsorbable mesh (similar to the material used instrong bioabsorbable sutures). The fibroblasts are obtained from human newborn foreskintissue. During the Dermagraft manufacturing process, the human fibroblasts are seededonto a bioabsorbable polyglactin mesh scaffold. The fibroblasts proliferate to fill theinterstices of this scaffold and secrete human dermal collagen, matrix proteins, growthfactors and cytokines, to create a 3-dimensional human dermal substitute containingAC-AESKI082011 Page 7 of 105Copyright 2016No part of this document may be reproduced without permission
ActiveHealth ManagementMedical Management Guidelines metabolically active, living cells. Dermagraft does not contain macrophages,lymphocytes, blood vessels, or hair follicles. It comes frozen as a single sheet (2 by 3inches) for a single applicationIn September 2001, FDA approved Dermagraft for marketing under the premarketapproval (PMA) process for "use in the treatment of full-thickness diabetic foot ulcersgreater than six weeks' duration which extend through the dermis, but without tendon,muscle, joint capsule or bone exposure. Dermagraft should be used in conjunction withstandard wound care regimens and in patients that have adequate blood supply to theinvolved foot."In support of FDA approval, a 12-week multi-center clinical study was performedinvolving 314 patients with chronic diabetic ulcers who were randomized to Dermagraftor control. Patients in the Dermagraft group received up to 8 applications of Dermagraftover the course of the 12-week study. All patients received pressure-reducing footwearand were encouraged to stay off their study foot as much as possible. By week 12, themedian percent wound closure for the Dermagraft group was 91 % compared to 78 % forthe control group. The study also showed that ulcers treated with Dermagraft closedsignificantly faster than ulcers treated with conventional therapy. Patients treated withDermagraft were 1.7 times more likely to close than control patients at any given timeduring the study. No serious adverse events were attributed to Dermagraft. There was alower rate of infection, cellulitis, and osteomyelitis in the Dermagraft treated group.Of the patients enrolled, 10.4% of the Dermagraft patients developed an infection while17.9 % of the Control patients developed ulcer infection. Overall, 19 % of the Dermagraftgroup developed infection, cellulitis, or osteomyelitis. In the control group, 32.5 %patients developed the same adverse events. Dermagraft has also been approved by theFDA for use in the treatment of wounds related to dystrophic epidermolysis bullosa.In May 2006, Advanced BioHealing purchased the global rights to Dermagraft fromSmith & Nephew.TransCyteTransCyte (Advanced Tissue Sciences Inc. La Jolla, CA), a bioactive skin substitute, wasgranted premarket approval (PMA) by the FDA in 1997 for "for use as a temporarywound covering for surgically excised full-thickness and deep partial-thickness thermalburn wounds in patients who require such a covering prior to autograft placement."TranCyte was not indicated for chronic wounds. TransCyte consists of human dermalfibroblasts grown on nylon mesh, combined with a synthetic epidermal layer. TransCytecan be used as a temporary covering over full thickness and some partial-thickness burnsuntil autografting is possible. It can also be used as a temporary covering for some burnwounds that heal without autografting. TransCyte is packaged and shipped in a cryopreserved state to burn treatment centers. The surgeon then thaws the product andAC-AESKI082011 Page 8 of 105Copyright 2016No part of this document may be reproduced without permission
ActiveHealth ManagementMedical Management Guidelines stretches it over a burn site. In about 7 to 14 days, the TransCyte starts peeling off, andthe surgeon trims it away as it peels.OrcelOrcel is an absorbable bilayered cellular matrix, made of bovine collagen, in whichhuman dermal cells have been cultured. OrCel (Forticell Bioscience, Inc., formerly OrtecInternational, Inc., New York, NY) is composed of normal, human, allogeneic, epidermalkeratinocytes and dermal fibroblasts (Snyder, et al., 2012). The cells are cultured in twoseparate layers into a type I bovine collagen sponge. Neonatal human fibroblasts andkeratinocytes are obtained from the same donor. According to the manufacturer, thematrix is designed to provide a structure for host cell invasion along with a mix ofcytokines and growth factors.The matrix is absorbed as the wound heals. Because of the extensive culturing process,the cells do not express the antigens responsible for rejection. The cells produce growthfactors. When this dressing is applied to the open wound created where the patient'shealthy skin was removed, the patient's own skin cells migrate into the dressing and takehold, along with the cultured cells, as healing commences. The dressing is graduallyabsorbed during the healing process.Orcel was approved by the FDA under its humanitarian device exemption (HDE) inFebruary 2001 for healing donor site wounds in burn victims, and for use in patients withrecessive dystrophic epidermolysis bullosa (RDEB) undergoing hand r
Integra Wound Matrix and Integra Flowable Wound Matrix for the management of wounds including partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical . SurgiMend for plastic and reconstructive surgery, muscle flap reinforcement, hernia repair .
Bruksanvisning för bilstereo . Bruksanvisning for bilstereo . Instrukcja obsługi samochodowego odtwarzacza stereo . Operating Instructions for Car Stereo . 610-104 . SV . Bruksanvisning i original
What does skin cancer look like? There are many different types of skin cancer (such as melanoma and basal cell skin cancer). Each type looks different. Also, skin cancer in people with dark skin often looks different from skin cancer in people with fair skin. A change on the skin is the most common sign of skin cancer. This may
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Hotell För hotell anges de tre klasserna A/B, C och D. Det betyder att den "normala" standarden C är acceptabel men att motiven för en högre standard är starka. Ljudklass C motsvarar de tidigare normkraven för hotell, ljudklass A/B motsvarar kraven för moderna hotell med hög standard och ljudklass D kan användas vid
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PG0365 – 12/22/2020 Amniotic Tissue Membrane Human Growth Factor Substitutes Platelet Rich Plasma Bone marrow aspirate processed to concentrate growth factors Bone graft substitutes containing anorganic bone material Allograft bone graft substitutes used exclusively as stand-alone stabilization devices for fusion B
outer part, the skin is prone to disease. One of these diseases is known as skin cancer. Skin cancer is an abnormality in skin cells caused by mutations in cell DNA. One of the most dangerous types of skin cancer is melanoma cancer. Melanoma is a skin malignancy derived from melanocyte cells, the skin pigment cells that produces melanin .
