The need for technologies to improve healing of leg ulcers in New Zealand has been recognized by the New Zealand Health Research Council (HRC) who have awarded a team led by Associate Professor Andrew Jull (University of Auckland) a Grant to conduct a fully-powered RCT comparing keramatrix® to standard care, see http://www.hrc.govt.nz/funding-opportunities/recipients/associate-professor-andrew-jull-0. Keraplast Technologies are pleased that the HRC recognise the potential for improved healing with keratin-based technology and are enthusiastically supporting this trial. Robert Allen Smith (MD), Keraplast’s medical director, says “Since developing our products, they have performed very well in-vitro as well as animal studies and many human studies and it is pleasing that HRC have recognised this potential and are funding a comprehensive clinical trial for VLUs where there is a well-recognized unmet clinical need”.
keramatrix®, a Replicine® Functional Keratin® advanced wound care treatment from Keraplast Technologies, has been granted reimbursement code Q4165 by the US CMS agency. The decision recognises the status of keramatrix® in the cellular or tissue based products (CTP) category, previously referred to as skin substitutes.
Gaining reimbursement coding allows clinicians to consider keramatrix® alongside other funded treatments for management of a wide range of wound indications, including venous leg ulcers, diabetic foot ulcers, donor sites and burns. Being able to gain reimbursement for keramatrix® is timely, as recent clinical findings continue to support the use of keramatrix® as a first choice in wound management. A February 2016 paper in the leading journal Burns demonstrated a 39% reduction in healing time and a 47% reduction in cost of care when using keramatrix® compared to standard of care controls. This adds to the 7 publications in the last 12 months of clinical research on Replicine® Functional Keratin® in different wound indications, including chronic wound care and dermatological disorders.
Dr Robert Allen Smith, MD and Medical Director of Keraplast said "Clinicians want to be able to choose the best available technology when managing wounds, in particular complex chronic wounds. Skin substitutes have long been a viable option, but to be considered a treatment option has to have a good evidence base and be able to be reimbursed. keramatrix® has been building a solid evidence base over several years, and now has the reimbursement status to make it a viable choice for clinicians."
keramatrix® has CMS code Q4165 and is available in two sizes, 10cmx10cm or 5cmx5cm.
Product information is available here.
A full guide to on how to apply keramatrix® reimbursement is available here.
keramatrix® reimbursement guide.
The latest findings on the use of Replicine® Functional Keratin® in wound healing have been published in Burns, the Journal of the International Society for Burn Injuries. The article, published in the January online edition of the world's leading burn journal, details the 80 patient cohort study on partial thickness and superficial burns, comparing burn management using keratin wound care with standard of care in the treatment facility. Burn patients, with an age range of 7 months to 69 years, had wounds treated with either keragelT®, keragel® or keramatrix® depending on location and exudate level of the wound. The keratin products were found to facilitate healing faster (mean healing time of 8.7 days compared to 14.4 days) with minimal permanent skin change or scarring reported for the treatment group. The keratin products were well tolerated with minimal pain and itch, a common issue at dressing change. The keratin treatments were easy to use and administer for the health professionals in both outpatients and community settings and a cost of care analysis showed a 47% cost saving compared to the control group.
Mr Jeremy Simcock (FRACS(Plast), MD(Melb)), PI for the study summarised the key finding as “The keratin products are found to facilitate healing with minimal scarring, be well tolerated with minimal pain and itch, be easy to use for the health professional and be cost effective for the health care provider. For these reasons they are being adopted into use at our facility.” Sharon Cassidy (CNS) commented "Since being involved in the clinical trial and seeing the outcomes for myself, I now routinely use the keratin-based products for all burn injuries that I treat in my community-based nursing practice. I like the idea that these dressing products not only promote a moist environment, but also donate something extra to the wound-bed (Keratin), which accelerates faster wound healing. I consistently get positive feedback from my clients on their results”
Dr Robert Allen Smith, Keraplast Medical Director said "fast epithelisation and so fast wound closure is crucial for good burn healing. As we have seen in clinical settings for both acute and chronic wounds, keragelT®, keragel® and keramatrix® encourage fast epithelisation. In burn management this reduces the risk of permanent skin change/scarring and we see that clearly from this study." He added "ease of application and patient comfort are clinically significant findings from the study also. Dealing with paediatric patients is complex and can be burdensome on hospital resources, particularly with burns on the face or hands. Minimal pain at dressing change and the high ease of use reported is important for routine clinical practice."
Dr Clive Marsh, Keraplast Wound Care Development Manager said "Replicine® Functional Keratin® products have been used extensively in many areas, including diabetic foot ulcers, venous leg ulcers, donor site healing and for scar management. This work demonstrates effectiveness in burn management and provides a good evidence base to support clinical decision making in burn care. It was encouraging to see good outcomes for the injuries (rapid healing, minimal permanent skin change/scarring), the patients (comfort and rapid resumption of ADLs), the health professionals (ease of use) and the health care system (reduced cost of care). With the wide availability of keragelT®, keragel® and keramatrix® throughout the world this gives clinicians a new option for burn care."
Replicine® Functional Keratin® wound care products, including keragel®, keramatrix®, kerasorb® and keragelT®, are available through a network of distributors throughout the world, including the EU, Asia and US. A detailed list for each region is available here.
Detailed information on keragel®, keramatrix® and other wound care products is available here.
Loan F, et al. Keratin-based products for effective wound care management in superficial and partial thickness burns injuries. Burns (2016), http://dx.doi.org/10.1016/j.burns.2015.10.024
Keraplast has extended distribution of its Replicine™ Functional Keratin® wound care product range to the Kingdom of Saudi Arabia through the appointment of Tiryaqi Advanced for Trading as exclusive distributor for the region. "We are excited to work with such a dynamic company focused on bringing innovative healthcare solutions to the clinicians in Saudi Arabia" said Dr Rob Kelly, Chief Scientific Officer of Keraplast. "This significantly extends our coverage and ensures patients living with epidermolysis bullosa, or suffering chronic wounds, can access the most advanced solutions available. Our advanced wound care technology is now available on every continent." Dr Mahmoud Salem, Vice President of Tiryaqi added "a high incidence of diabetes means the unmet clinical needs in the areas of chronic wound care in our region is significant, and we focus on bringing the most advanced solutions available to our clinical partners. In addition, to work closely with those families living with epidermolysis bullosa, and offer them the best in class care, is very important for us." For more information contact:
Tel: +966 12 657 2470
Fax:+966 12 651 5218
Web Site: http://tiryaqi.com/
Epidermolysis bullosa (EB) is a severe and debilitating genetically inherited condition which causes skin fragility, leading to skin damage, skin loss and wounding. New research conducted at the Great Ormond Street Hospital, London, UK, published in the October 2015 issue of Journal of Wound Care details the use of the keratin product keragelT® in management of this condition.
In the study a ten patient convenience sample of patients enrolled at the specialist clinic used keragelT® as part of daily wound care for periods of up to 20 weeks on both chronic and acute wounds. Patients reported faster healing and more resilient healed skin compared to standard of care. Consistent with other studies on the keratin gel, improvements in quality of life were also reported. Full details of the study can be found here http://www.magonlinelibrary.com/doi/10.12968/jowc.2015.24.10.446.
October 25th-31st is Epidermolysis Bullosa Awareness Week.
Make a difference for families living with this devastating condition today by donating to the charity DEBRA here.