CLINICAL EVIDENCE Partial and Deep Partial Burns Endoform helps to improve re-epithelialization after burn injuries Endoform helps to facilitate tissue granulation and epithelialization in partial and deep partial burns.1,2 Weekly treatment of Week 0: Week 4: Week 1: Week 11: deep partial burns with Endoform helped lead to 100%reepithelialization of wounds after 11 weeks.1 Use of Endoform may reduce the need for surgical skin grafting.2 In a clinical study, Endoform treated wounds were not hypertrophic and the patients were satisfied by cosmetic outcomes.2 By week 11, Endoform treated burns are 100% re-epithelialized.1 Week 3: Endoform can be used at all phases of wound management Stabilize Hemostasis MKT.1442.01 Correct Inflammation Build Proliferation Organize Remodelling Wound Closure
CLINICAL EVIDENCE Partial and Deep Partial Burns Natural Dermal Template Antimicrobial Dermal Template References: 1. Zilberman, I. (2015). Case Study 19: Bilateral Feet + Second Degree Burn. 2. Aballay, A. and E. Tolchin (2018). Results of an ovine extracellular matrix dressing in the management of a variety of burns and wounds. The Symposium on Advanced Wound Care Charlotte, NC. 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. 340 Progress Drive, Manchester, CT 06042 Endoform Dermal Template is marketed in the USA by Appulse MKT 1442.01 May 2018
Bilateral Feet - Second Degree Burn Patient: 77 year-old male with second degree burn. Diabetic with peripheral neuropathy Second degree burn to bilateral feet due to prolong standing by the pool area Previous treatment: Hospitalized for debridement and antibiotic therapy Cellular tissue based products x 3 After 3 applications of cellular tissue based products, there were 3 areas still open Wound Treatment: Endoform dermal template, Restore contact layer FLEX, Hydrofera Blue classic foam secured with stretch gauze. Dressings changed weekly per clinician s preference. At week 4, when drainage diminish to moderate amount, treatment was changed to Endoform dermal template, covered with Restore contact layer FLEX, Hydrofera Blue Ready foam, secured with stretch gauze. Changed weekly. Week 0: Endoform application Right forefoot: 6 cm x 5 cm x 0.5 cm Left heel: 1 cm x 1 cm x 0.3 cm Left forefoot: 5 cm x 3 cm x 0.5 cm Week 1: Right forefoot: 4 cm x 4 cm x 0.5 cm Left heel: 1 cm x 1 cm x 0.3 cm Left forefoot: 4.5 cm x 3 cm x 0.5 cm Week 3: Right forefoot: 1 cm x 3 cm x 0.3 cm Left forefoot: 1 cm x 1 cm x 0.2 cm Left heel: Re-epithelized Week 14 Right forefoot: 0.5 cm x 1 cm x 0.2 cm Left forefoot: 0.8 cm x 0.5 cm x 0.2 cm Week 11: All wounds 100% Re-epithelialized
CASE STUDY 19 Bilateral Feet - Second Degree Burn Case provided by: Deborah Felton, RN, BSN, WCC; Mount Carmel East Hospital, Columbus, OH 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 340 Progress Drive, Manchester, CT 06042
Results of an ovine extracellular matrix dressing in the management of a variety of burns and wounds Ariel Aballay, MD, FACS Eric Tolchin PA-C West Penn Burn Center, Department of Surgery, Western Pennsylvania Hospital; Allegheny Health Network, Pittsburgh, PA Introduction: Wound care affects 5.7 million people at an annual cost of $20 billion. 1 A common dilemma for Burn Surgeons is balancing outcomes with cost of care. Frequently faced with deep partial thickness wounds post-surgical debridement, many utilize a dermal skin substitute or extracellular matrix. We recently discovered a collagen extracellular matrix (CECM) derived from ovine forestomach* and indicated for partial and full thickness wounds. CECM dressings may help modulate matrix metalloproteases. An intact native extracellular matrix helps to promote tissue granulation 2 and epithelialization for final wound closure. 3 Case Study 1: Patient: 38 year-old female patient was undergoing a colposcopy; she sustained chemical burn to buttocks Acute myeloid leukemia Silver sulfadiazine dressing QID Day 18, post-injury, all wounds were debrided. CECM was applied to wounds post debridement per manufacturer s guidelines Case Study 2: Patient: 21 year-old male with 3 full-thickness electrical wounds to left foot Paraplegic secondary to spinal bifida Surgical debridement performed with placement of bilayer matrix. IV antibiotics in hospital CECM covered with a non-adherent contact layer dressing changed weekly Case Study 3: Patient: 26 year-old male sustained 2nd degree thermal burn to right hand Previous wound history: Silver sulfadiazine and an oral antibiotic Surgical debridement performed 10 days post-injury. CECM dressing applied post debridement in the OR and covered with a non-adherent dressing and gauze wrap Case Study 4: Patient: 49 year-old male presented with cellulitis and a non-healing wound over right anterior tibia s/p fall Surgical debridement of wound; cellulitis treated with oral antibiotics CECM dressings to tunnel and wound bed, covered with a non-adherent contact layer dressing. Dressings changed 3x a week In this 4-case series, CECM dressings were used in the management of wounds with deep dermal deficits due to surgical debridement. The applicability of this option was used for early aggressive wound management to treat acute wounds. Methodology: A convenience sampling of 4 wounds and burns were selected. Patients who would be a potential candidate for a dermal skin substitute or a skin graft were chosen. CECM dressings were applied in the OR post-surgical debridement according to manufacturer s instructions for use. Patients were followed through to wound closure. Week 0 Pre-debridement, 100% slough tissues with rolled edges CECM Week 2 Wound bed with granulation tissues with continued epithelialization Day 1 Post debridement. Wound clean. CECM dressing initiated Day 18 Day 0 Pre-debridement Day 17 Wound closure Day 0 Debridement in OR. CECM applied under NPWT Day 38 NPWT discontinued; CECM continued with weekly application Results: All wounds proceeded to closure without complications. In 3 patients, wounds progressed to closure, not requiring surgical skin grafting. One patient required application of a skin graft for final wound closure. Conclusion: CECM is an intact, native extracellular matrix dressing which may facilitate tissue granulation and epithelialization for final wound closure. In this case series, three out of four patients did not require surgical skin grafting. The healed wounds were not hypertrophic and patients were satisfied by the cosmetic outcome. Week 1 Epithelial buds noted on wound bed. CECM dressings noted on wound edge Week 8 100% Re-epithelialized. Wound closed without further need for surgery Day 6 Wound bed with granulating tissues. Periwound skin intact Day 30 100% re-epithelialized Day 10 CECM incorporating on right hand. CECM reapplied Day 9 CECM, applied weekly under NPWT. NPWT dressing changed 3 times a week, per instructions for use Day 45 CECM discontinued. Patient was scheduled for skin graft REFERENCES 1. Järbrink, Krister, et al. The Humanistic and Economic Burden of Chronic Wounds: a Protocol for a Systematic Review. Systematic Reviews, BioMed Central, 24 Jan. 2017. 2. Tonnesen MG et al. Angiogenesis in Wound Healing. The Society for Investigative Dermatology, Inc. Vol 5, 1; 2000. 3. Pastar I et al. Epithelialization in Wound Healing: A Comprehensive Review. Adv in Skin and Wound Care, Vol 3, 7; 2014. Lindholm, Christina, and Richard Searle. Wound Management for the 21st Century: Combining Effectiveness and Efficiency. International Wound Journal, Blackwell Publishing Ltd, 27 July 2016. Bohn, Gregory, et al. 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, supplement Nov. 2017, pp. S37 S42. Endoform dermal template IFU Lun S, Irvine SM, Johnson KD. A functional extracellular matrix biomaterial derived from ovine forestomach. Biomaterials 2010;31:4517 4529. Irvine SM, Cayzer J, Todd EM, et al. Quantification of in vitro and in vivo angiogenesis stimulated by ovine forestomach matrix biomaterial. Biomaterials. 2011;32:6351 6361. Simcock J, May B. Ovine forestomach matrix as a substrate for single-stage split-thickness graft reconstruction. eplasty. 2013;13:495-502. * Endoform TM dermal template, Manufactured for Hollister Incorporated. Financial Disclosure: The author received an honorarium from Hollister Incorporated. Aballay, A. and E. Tolchin (2018). Results of an ovine extracellular matrix dressing in the management of a variety of burns and wounds. The Symposium on Advanced Wound Care Charlotte, NC. 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. 340 Progress Drive, Manchester, CT 06042