Clinical Data Supports the Claim that ActiGraft+® System is a Viable Solution for Complex Wounds
Figure 1
Jacksonville, Fla, Jan. 20, 2023 (GLOBE NEWSWIRE) — RedDress, a privately held U.S. and Israel-based medical device company, today announced that new data has been published outlining their wound care product, ActiGraft+, use on complex wounds.
“Clinical data is foundational to validating our technology and progressing how clinicians manage wounds to improve their patient’s outcomes,” said Sharon Sirota, Clinical Team Leader at RedDress. Our latest Consensus paper’s findings clearly outline how our technology is effective even in the most complex of wounds.”
The consensus panel included a core group of 9 clinicians from the United States and Germany with extensive experience in wound care and surgical wound care management to develop a consensus of decision pathways and recommendations for TABCT (Topical Autologous Blood Clot Therapy) use in specific complex wound types. The clinicians in the panel defined four recommendations focused on complex diabetic foot ulcers, pressure injuries, venous ulcers and surgical wounds that had tunneling, exposed bone and/or tendon and could not undergo sharp debridement.
- TABCT should be applied to wounds after adequate debridement in patients in which this can be performed. For patients who cannot undergo debridement, TABCT is still a viable treatment option because it maintains a moist wound environment which has the ability to aid in autolytic debridement.
- TABCT can be used as a physical barrier to prevent bacteria from the surrounding skin and the external environment from entering the wound bed.
- TABCT is a viable treatment option for patients with irregular wound beds or tunneling. The flowable solution1 is able to fill the entire wound bed allowing the application to send beneficial growth factors to the wound.
- TABCT can be used in full-thickness wounds with exposed tendon and/or bone to serve as a barrier to bacterial ingress and assist in maintenance of a moist wound healing environment to aid in conversion from a proinflammatory to an anti-inflammatory state of healing and prevent desiccation and/or necrosis of exposed structures.
The panel concluded that ActiGraft+ is a viable option for these complex wounds because it can assist in autolytic debridement, achieve complete wound bed coverage, maintain a moist wound healing environment and provide structural support necessary for wound healing to occur.
“Autologous therapies are considered the latest cutting-edge technology to be utilized in wound care. These statements as well as previously published clinical data highlight that using autologous therapies on complex, hard-to-heal wounds is an effective and viable solution for the patient,” said Dr. Robert Snyder, one of RedDress’ medical advisors.
In addition to the four consensus statements, the panel integrated ActiGraft+ into the DIME wound care management model; see Figure 12 for more information.
About the Suite of ActiGraft Products
ActiGraft and ActiGraft+, based on RedDress’ proprietary patented technology, are FDA-cleared wound care solutions that enable health care providers to produce – in real time – an in vitro blood clot from a patient’s whole blood. Once applied, the blood clot serves as a protective covering and supports wound healing processes which naturally occur in the patient’s body.
ActiGraft and ActiGraft+ are intended for exuding cutaneous wounds. The systems include blood-contacting components that have been sterilized by Ethylene Oxide, which may cause serious allergic reactions in patients that are sensitized. For full prescribing information, visit www.reddressmedical.com/safety-info.
About RedDress
RedDress (www.reddressmedical.com) is a privately held, Israel-based company with a U.S. subsidiary, RedDress Inc., located in Ponte Vedra Beach, Florida. Founded in 2009 with the goal of developing more effective, natural, and economically viable treatments for chronic wounds, we’re proud to expand our suite of products to include ActiGraft and our latest innovation – ActiGraft+.
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ActiGraft® system is a registered trademark of RedDress Ltd.
ActiGraft+® system is a registered trademark of RedDress Ltd.
1 Snyder, R. et al. Topical Autologous Blood Clot Therapy: An Introduction and Development of Consensus Panel to Guide Use in the Treatment of Complex Wound Types. WOUNDS.
2 Et al.
Attachment
- Figure 1
CONTACT: Alessandra Lalli RedDress 2032974404 [email protected]
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