CLINICAL EVIDENCE Treatment of Venous Leg Ulcers (VLUs)

Transcription

1 CLINICAL EVIDENCE Treatment of Venous Leg Ulcers (VLUs) Endoform can help to improve healing and lower the cost of VLU management Endoform can be used from day one in difficult-to-manage VLU s. 1, 2, 3, 4 Endoform does not need to be removed and requires fewer dressing changes than other products; which may lead to greater patient satisfaction and compliance. 5 Endoform reduces the cost of VLU treatment because application can be carried out by a range of wound care practitioners (no suturing required) and subsequent applications can be carried out by the patient at home. 5 A case series using Endoform was shown to result in 95.7% closure of VLUs in 12 weeks with an average closure time of 7.3 weeks (n=23 wounds, ranging in size from cm2, in 14 patients). 5 Early reduction in wound area (20-40% in the first 2-4 weeks of treatment) is a good predictor of healing. 6 In a clinical study, 4 weeks of Endoform treatment resulted in complete closure in 40% of cases (n=28). 1 Week 0: Week 11: Week 7: Endoform treatment of ankle VLU. 5 Endoform can be used at all phases of wound management Stabilize Correct Build Organize Hemostasis Inflammation Proliferation Remodelling Wound Closure MKT

2 CLINICAL EVIDENCE Treatment of Venous Leg Ulcers (VLUs) Natural Dermal Template Antimicrobial Dermal Template References 1. Lullove, E. (2016). Use of Ovine Collagen Extracellular Matrix and Gentian Violet and Methylene Blue Antibacterial Foam Dressings to Help Improve Clinical Outcomes in Lower Extremity Wounds. Symposium on Advanced Wound Care - Fall, Las Vega, NA. 2. Liden BA, (2011). Case Study 1: Mixed Vascular Disease, from "Early Clinical Findings From The Use Of Endoform Dermal Template (Ovine Forestomach Matrix) To Treat Recalcitrant Wounds"; Presented at Symposium on Advanced Wound Care, April 14-17, 2011 Dallas, TX 3. Liden BA, (2011). Case Study 3: Mixed Vascular Etiology, from "Early Clinical Findings From The Use Of Endoform Dermal Template (Ovine Forestomach Matrix) To Treat Recalcitrant Wounds"; Presented at Symposium on Advanced Wound Care, April 14-17, 2011 Dallas, TX. 4. Curran, M. (2013). Case Study 9: Venous Ulcer, Aroa Biosurgery. 5. Bohn, G. A. and K. Gass (2014). "Leg ulcer treatment outcomes with new ovine collagen extracellular matrix dressing: a retrospective case series." Adv Skin Wound Care 27(10): Bohn, G. A., G. S. Schultz, B. A. Liden, M. N. Desvigne, E. J. Lullove, I. Zilberman, M. B. Regan, M. Ostler, K. Edwards, G. M. Arvanitis and J. F. Hartman (2017). "Proactive and Early Aggressive Wound Management: A Shift in Strategy Developed by a Consensus Panel Examining the Current Science, Prevention, and Management of Acute and Chronic Wounds." Wounds 29(11): S37-S42. RX Only. Prior to use, be sure to read the entire Instructions for Use package insert supplied with the product. For product questions, sampling needs, or detailed clinical questions concerning our products in the US, please call HCPCS are for reference only and subject to change. Endoform is a registered trademark of Aroa Biosurgery Limited. Manufactured for: AROA BIOSURGERY INC 340 Progress Drive, Manchester, CT Endoform Dermal Template is marketed in the USA by Appulse 2018 Aroa Biosurgery Limited MKT May 2018

3 Use of Ovine Collagen Extracellular Matrix and Gentian Violet and Methylene Blue Antibacterial Foam Dressings to Help Improve Clinical Outcomes in Lower Extremity Wounds Eric J. Lullove, DPM, CWS, FACCWS West Boca Center for Wound Healing, Boca Raton, FL Purpose: To analyze our clinical outcomes with use of ovine collagen extracellular matrix (CECM)* and gentian violet/methylene blue (GV/ MB) polyurethane (PU) antibacterial foam dressings** in treating chronic lower extremity wounds. Introduction: Chronic lower extremity wounds are increasingly more prevalent and complex to treat, and are a significant cause of morbidity and drain on healthcare resources worldwide. Patient comorbid conditions such diabetes, peripheral vascular disease and obesity can delay wound healing, and must be clinically addressed to correct causes of tissue damage. In addition to underlying medical conditions, chronic wounds are characterized by a complex etiology that can include abnormal cell-extracellular matrix (ECM) interactions, elevated bioburden levels and bacterial biofilm, imbalances of matrix-metalloproteinases (MMP), and an unresolved inflammatory response all of which can damage the wound ECM. 1,2 Dressings that provide broad spectrum MMP reduction along with inherent aspects of an ECM may contribute to improved wound healing outcomes and shorter treatment times. 3 Preliminary reports of a CECM dressing have demonstrated benefits in chronic wound healing. 4,5 Methodology: Retrospective chart analysis was performed on observational data of consecutive patients with chronic lower extremity ulcers who were managed with CECM as a primary dressing and MB/GV PU antibacterial foam dressing to manage bioburden as a secondary dressing in an outpatient setting. All patients were treated twice weekly in the clinic for the first four weeks. During the first visit, wounds were cleansed with saline or dermal cleanser, sharp debrided as needed, and a CECM dressing covered with a MB/GV PU antibacterial foam was placed. At the mid-week appointment, wounds were again cleansed and examined, but not sharp debrided. An additional CECM dressing was placed if the previous CECM dressing was fully integrated into the wound and the MB/GV PU antibacterial foam was replaced. After the initial four week period, patients received once weekly treatment consisting of cleansing, sharp debridement as needed, and a CECM dressing covered with a GV/MB PU antibacterial foam until wound was healed. Results: Patient demographics n % Patients (n) 53 Male % Female % Mean age (years) 75.9 Mean Body Mass Index (BMI) 28.3 Wounds treated (n) 53 Mean wound area at presentation (cm2) 5.8 Fifty-three patients with 53 wounds were treated. Types of wounds treated were diabetic foot ulcers (n=22), venous leg ulcers (n=28), and heel pressure ulcers (n=3). Average BMI for study population was 28.3 using a standard BMI formula with a BMI between 25 and 30 being overweight; average patient age was 75.9 years. Mean percent wound size reduction at 4 weeks was 38.5%; mean wound size reduction at 8 and 12 weeks was 73.3% and 91.3%, respectively. 11/22 (50.0%) DFUs and 13/28 (46.4%) VLUs achieved at least 40% closure at week 4. Average time to heal for all wounds was 10.6 weeks (range: 5 to 24 weeks). All wounds were 100% re-epithelialized by week 20 except one DFU that was re-epithelialized at week 24. All patients responded well to treatment, with no reported adverse reactions or adverse side effects. Discussion: Overall, the use of CECM covered with MB/GV PU antibacterial foam in an overweight, advanced-age population was successful with an average time to closure of 10.6 weeks for wounds in this series. It is interesting to note that 24/25 wounds that did not achieve greater than 40% wound surface area reduction by week 4 progressed to complete closure by week 20, with no additional wound treatment besides weekly application of CECM and MB/GV PU antibacterial foam dressings. Rates of wound size reduction at 4, 8, and 12 weeks were similar between VLUs and DFUs. Average % Wound Closure Patient outcomes n (%) Avg area Avg time Avg % area Avg % area Avg % area 40% 40% 100% 100% at 0 weeks to healing closed at closed at closed at closure at closure at closure at closure at (cm2) (weeks) 4 weeks 8 weeks 12 weeks 4 weeks n(%) 8 weeks n(%) 12 weeks n(%) 20 weeks n(%) Wounds treated (n) 53 (100.0) % 73.3% 91.3% 25 (47.2) 49 (92.5) 31 (58.5) 52 (98.1) DFU (n) 22 (41.5) % 76.5% 90.6% 11 (50.0) 20 (90.9) 13 (59.1) 21 (95.5) VLU (n) 28 (52.8) % 70.9% 92.6% 13 (46.4) 26 (92.9) 17 (60.7) 28 (100.0) PrU (n) 3 (5.7) % 72.0% 84.3% 1 (33.3) 3 (100.0) 1 (33.3) 3 (100.0) Wound surface area reduction over 20 weeks (percent) DFU (n=22) 60 VLU (n=28) 50 PrU (n=3) Weeks Compared to VLUs, DFUs showed a slightly greater percent size reduction rate at 8 weeks, but a lesser size reduction at 12 weeks. This is consistent with our observation that DFUs in this series took longer than VLUs to progress to full healing during the reepithelialization phase, but considerably more research is required to validate this observation. Drawing conclusions regarding pressure ulcer healing in this series was difficult due to low subject numbers. REFERENCES 1. Schultz GS, Wysocki A. Interactions between extracellular matrix and growth factors in wound healing. Wound Repair Regen 2009;17(2): McCarty SM, Percival SL. Proteases and Delayed Wound Healing. Adv Wound Care (New Rochelle) Oct;2(8): Bohn G, Liden B, Schultz G, Yang Q, Gibson D. Ovine-based collagen matrix dressing: Next generation collagen dressing for wound care. Adv Wound Care (New Rochelle) 2016 Jan 1;5(1): Liden BA, May BC. Clinical outcomes following the use of ovine forestomach matrix (endoform dermal template) to treat chronic wounds. Adv Skin Wound Care Apr;26(4): Bohn GA, Gass K. Leg ulcer treatment outcomes with new ovine collagen extracellular matrix dressing: a retrospective case series. Adv Skin Wound Care Oct;27(10): * Endoform dermal template, Distributed by Hollister Incorporated. ** Hydrofera Blue Ready foam, Distributed by Hollister Incorporated. Financial disclosure: Author received an investigator-initiated research study grant from Hollister Incorporated Case Study Patient: 66 year-old male patient with history of T2DM and HIV presented with anterior left ankle wound secondary to increased compression from treatment of pressure ulcer to heel that was almost closed. Patient was self-treating wound when he changed his dressing and over-tightened the gauze wrap on his left ankle. Week 0: 4.5 cm x 4.5 cm x 0.4 cm Initial presentation Anterior tibialis tendon exposed Wound treatment: Sharp debridement, CECM dressing applied with MB/GV PU antibacterial foam cover with dressings applied twice a week. Week 13: 1.2 cm x 1.2 cm x0.1 cm 93% wound closure Wound treatment: CECM dressing applied with MB/GV PU antibacterial foam cover with dressings applied one time a week. Week 7 Complete granulation over the tendon with contraction of wound edges Wound treatment: CECM dressing applied with MB/GV PU antibacterial foam cover with dressings applied one time a week. Week 15 Complete epithelialization Lullove, E. (2016). Use of Ovine Collagen Extracellular Matrix and Gentian Violet and Methylene Blue Antibacterial Foam Dressings to Help Improve Clinical Outcomes in Lower Extremity Wounds. Symposium on Advanced Wound Care - Fall, Las Vega, NA. Caution: Federal (USA) law restricts this device for sale by or on the order of a physician or licensed healthcare professional. Refer to Instruction for Use for contraindications, warnings, precautions and possible complications. Endoform is a trademark of Aroa Biosurgery Limited Aroa Biosurgery Limited Manufactured for: AROA BIOSURGERY INC 340 Progress Drive, Manchester, CT

4 CASE STUDY 1 Mixed Vascular Disease Sex: Co-morbidities: Wound Type: Wound Location: Wound Age: Previous Treatments: Secondary Dressing: Outcomes: Endoform applications: Female Non-insulin dependent diabetes Congestive heart failure Congestive obstructive pulmonary disease Peripheral vascular disease Mixed Vascular Left ankle 1 year Compression Sharp debridement Silver dressing Steroid therapy Non-adherent dressing Rolled gauze Compression therapy Offloading pressure device Granulation tissue at Week 5 Complete healing at Week 11 9 Week 0: Week 7: Wound area over time Week 7:

5 Initial Preparation The wound was surgically debrided down to viable tissue and irrigated with hypochlorous acid solution and treated with a silver dressing and compression. The wound was assessed for visible signs of infection (i.e., absence of swelling, pain, purulent drainage, or tracking into the deep tissue planes). The wound had to remain free of infection to start using the Endoform dermal template. Silver dressing treatments were stopped at this time. Endoform dermal template Application Using aseptic technique, Endoform dermal template was trimmed to roughly overlap the wound margins, placed on the wound bed and rehydrated with sterile saline. Following hydration, the color of the dressing changed from white to opaque. Light pressure was applied to the dressing to ensure that it conformed to the underlying wound bed. The dressing was covered with a nonadherent secondary dressing. Compression stockings, exudate control and offloading were used as required. Follow-Up The patient received weekly follow-up, during which time the wound was debrided as required and irrigated to remove loose material. The Endoform dermal template was reapplied on a weekly basis. Changes in the wound granulation tissue, epithelial tissue and wound dimensions were monitored and recorded using digital photography. Observations In approximately three days, the dressing had adhered to the underlying wound bed. After seven days, the dressing was completely integrated into the wound bed. In some cases, only remnants of the dressing remained as an off-white gel that was allowed to remain in place during subsequent applications of Endoform dermal template. Case provided by: Liden BA, Ward BR, May BCH; Early Clinical Findings From The Use Of Endoform Dermal Template (Ovine Forestomach Matrix) To Treat Recalcitrant Wounds; Presented at Symposium on Advanced Wound Care, April 14-17, 2011 Dallas, TX. RX Only. Prior to use, be sure to read the entire Instructions for Use package insert supplied with the product. For product questions, sampling needs, or detailed clinical questions concerning our products in the US, please call HCPCS are for reference only and subject to change. Endoform is a registered trademark of Aroa Biosurgery Limited. Endoform Dermal Template is marketed in the USA by Appulse Manufactured for: AROA BIOSURGERY INC 340 Progress Drive, Manchester, CT Aroa Biosurgery Limited

6 CASE STUDY 3 Mixed Vascular Etiology Sex: Female Co-morbidities: Wound Type: Wound Location: Diabetes Congestive heart failure Venous reflux Mixed vascular Left lower medial leg, anterior ankle Week 0: Wound Age: 1+ year Previous Treatments: Secondary Dressing: Outcomes: Endoform applications: Compression Sharp debridement Enzymatic debrider Growth factos Skin substitute (x4) Silver dressing Non-adherent dressing Rolled gauze Granulation tissue at week 4 Complete Healing at week 9 6 Week 4: Wound area over time Week 9:

7 Initial Preparation The wound was surgically debrided down to viable tissue and irrigated with hypochlorous acid solution and treated with enzymatic debriding agent and compression. The wound was assessed for visible signs of infection (i.e., absence of swelling, pain, purulent drainage, or tracking into the deep tissue planes). The wound had to remain free of infection to start using the Endoform dermal template. Previously used dressings and enzymatic debriding treatments were stopped at this time. Endoform dermal template Application Using aseptic technique, the Endoform dermal template was trimmed to roughly overlap the wound margins, placed on the wound bed and rehydrated with sterile saline. Following hydration, the color of the dressing changed from white to opaque. Light pressure was applied to the dressing to ensure that it conformed to the underlying wound bed. The dressing was covered with a nonadherent secondary dressing. Compression stockings, exudate control and offloading were used as required. Follow-Up The patient received weekly follow-up, during which time the wound was debrided as required and irrigated to remove loose material. The Endoform dermal template was reapplied on a weekly basis. Changes in the wound granulation tissue, epithelial tissue and wound dimensions were monitored and recorded using digital photography. The wound was monitored for a further four weeks. Observations In approximately three days, the dressing had adhered to the underlying wound bed. After seven days, the dressing was completely integrated into the wound bed. In some cases, only remnants of the dressing remained as an off-white gel that was allowed to remain in place during subsequent applications of Endoform dermal template. Case provided by: Liden BA, Ward BR, May BCH; Early Clinical Findings From The Use Of Endoform Dermal Template (Ovine Forestomach Matrix) To Treat Recalcitrant Wounds; Presented at Symposium on Advanced Wound Care, April 14-17, 2011 Dallas, TX. RX Only. Prior to use, be sure to read the entire Instructions for Use package insert supplied with the product. For product questions, sampling needs, or detailed clinical questions concerning our products in the US, please call HCPCS are for reference only and subject to change. Endoform is a registered trademark of Aroa Biosurgery Limited. Endoform Dermal Template is marketed in the USA by Appulse Manufactured for: AROA BIOSURGERY INC 340 Progress Drive, Manchester, CT Aroa Biosurgery Limited

8 CASE STUDY 9 Venous Ulcer Patient: 53-year-old male, presented with a venous ulcer wound to the left ankle Wound characteristics and prior treatment: The wound was treated initially with zinc-paste-impregnated gauze and an alginate dressing Treatment: After debridement, wound measures 1 cm x 1 cm x 0.2 cm. Endoform dermal template treatment begun Week 3, wound measures 0.7 cm 0.8 cm x 0.1 cm Wound cleansed with normal saline Sharp debridement to remove devitalized wound base tissue Endoform dermal template was applied, covered with a secondary foam dressing, and secured with tape Week 4, wound measures 0.6 cm 0.9 cm x 0.2 cm Results: Initial wound measurement after debridement was 1.0cm x 1.0cm x 0.2cm After seven weeks of treatment, wound had decreased to 0.2cm x 0.2cm x 0.1cm Week 5, wound measures 0.4 cm 0.8 cm x 0.2 cm Week 7, wound measures 0.2 cm 0.2 cm x 0.1 cm

9 CASE STUDY 9 Venous Ulcer Case provided by: Maeve Curran, PT, CWS, CLT; Desert Regional Medical Center, Palm Springs, CA RX Only. Prior to use, be sure to read the entire Instructions for Use package insert supplied with the product. For product questions, sampling needs, or detailed clinical questions concerning our products in the US, please call HCPCS are for reference only and subject to change. Endoform is a registered trademark of Aroa Biosurgery Limited. Manufactured for: AROA BIOSURGERY INC 340 Progress Drive, Manchester, CT Endoform Dermal Template is marketed in the USA by Appulse 2018 Aroa Biosurgery Limited

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11 Pub,, USh-.llbl'l'ol....,. PubMed H...,... H,, If> Advanced Help Foonat: Abstract Nav;29(11) $37--$42 Proactive and Early Aggressive Wound Management: A Shift in Strategy Developed by a Consensus Panel Examining the Current Science, Prevention, and Management of Acute and Chronic Wounds. illlllll.qmjgl!ulll,.zill1ama.=.liilllm,. Send to... Abstract Normal wound healing is aocotnplished th1ough a series of well-eoordinat&d, ptogressive events wi1h overlapping phases. Chronic wounds are desaibed as not progress i ng lo healing or nol being responsive lo mal\agement in a timely manner. A consensus panel 01 multidisciplinary wound care professionals was assembled to (1) educate wound ca.re practitioners by identifying key principles of the basic science of chroni<: wound pathophy-$iology, highlighting the impact of metalloproleklases and biofitms, as well 8$ the role of the e racellular matrix; and (2) equip practitioners with a syslematic strategy for lhe prevention and heating ol acule injuries and chronic wounds based upon scientific evidence and the panel members' expertise. An algorithm is presen1ed that represents a shifl in strategy to proactive and earty agg,essive wound management Wit11 proactive mamgement. adjuncl therapies a,e applied preemptively to acute injuries to reduce wound duration and risk ol ctironicity. For existi chronic wounds. earty aggressive wound management is employetd to bleak the pattioptiysiology cycle and drive wounds Ioward healing. Reducing biol>urden through debridernent and bioburden managemenl and using collagen dressings to balance protease act i vity prior to lhe use of advanced modalities may enhance their effectivefless. This earty aggressive wound management slrategy is reoommend&d for patients at high risk lor chronic: wound development al a minimum. In their own practices. lhe panel members apply lhis systemalic stralegy for aji patients presenting with acute injuries or Chronic wounds. PMID Free full text Full text links I,..,,_ti:: I.WOUNDS Save items Add to Favorites Similar 8rticles Community-based care lor chronic wound management: [Ont Health Temnol Assess ser. Management ot chronic pressure s: an evidencebas< [Ont Health Temnol Assess Ser. EWMA Documenl: Nogative Pressure Woond Therapy. IJ -.nc1 ca,e cmmm Systematic revie'ns ol womd caie management: (3),!Health Tect,nol Assess. 2000) C!ll'ElJ Recommenclalions f"' the management of biofilm: a consensu$ do< IJ _,ncl care 2016) see,ev1ews... Seeal... WOUNDS la.a\\l '7 < I 11 I q JCll ;,r., \L HCI.IE SUBSCRIBE l'bue \1ULT1MECIA EDLIC)TlON U0UlU3!IIGN JP LCG M in Proaclive and Early Aggressive Wound Management A Shifl in Strategy Developed by a Consensus Panel Examining tho Current Science, Prevention, and Management of Acute and Chronic Wounds 1-W'IU OOMMI.JNl(.;,\110!{emote errperature Moortonng 1n mati. c i=oot U l cn C c-tcc-j"' ill 11'11. 01/1,?"l I Orwc; PROACTIVE AN a EARLY AGGRESSIVE WOUND MANAGEMENT: A Shift in Strategy Des eloped tiy a Consensus Panel E<ilmining the Current Science, P,e,ent,on and Management of Acute and Chronic Wound, Abstrut l11bodud.iur1. i:l.llqh; r ll Llu:Mi. (OF Ji.: i:41'::i ass:dated \\'itt ioa..at,a,d 1101:,d ::y. n'iol'talir,'. ;md resource utilization. Rerrcte f raftlu! rrvdiulnn :RT\11"1 :'I H <!\1,1rm, r. t'i::rm :md r<'!n'lrrrnr.ndr. 1 w1n1,1u11 11l L f -li.111u,11j p1::vt11lt.1liv.: L ul c,ara torhi3h-<i : p Llations :hat car dgt;;ct lhe i111f amr a;:ion poeceding and IIN'.:-,... r;;n lfl!] 11FIJ r.:-.'lini1p r!'.=o,1inf1 MOST rorular ARTl::. s tlnrfor i;ndln!j Ol!'ll'W'!tk.lndur.Tlon nf Cdl JliJ1 Si.:m.: i.:cm;i:; A Cund:.c R.:vi w -OJUay:Q'V/101-li? Chairaderiitic!o ot U19ical Site l11 ction rcllo 1oin!=j Cclon-ctal Surge,r/ in o TErtief'l c.,mrp.r! F:rriP.:rwiP.il 'lflf:r:rrum fu nr.10mr. P.- 1J1Uth.n:i11f 8ai.;Lc1i;:, Cul iitit:. in Dbt. c::;t , '.&nflnl "'"""""' Edito,iol Meg e: Yoo U'fom to Spit on r.tywr,un:t'? -- -:sa,,1 2111s1r1 ni,lid!; tdiluti;:11 MY6ti,i,t\J ; Huv, Ou Yoo t1;-.11rji Adl"&ft.ity'i'