We Can Now Say Bye-bye To Bandages, Discover New Technology Heals Wounds Using Patient’s Blood
In the wake of developing more effective medical solutions, the health sector will experience a major improvement in wound treatment methods other than the use of traditional bandages. Recently RedDress, an innovative wound care solution, has unveiled its revolutionary ActiGraft PRO product, which has given rise to the question of Bye-bye bandages. This ground-breaking innovation has gained national recognition from both Medicare and Medicare Advantage through the utilization of NCD 270.3 and G-0465 & G-0460 codes. ActiGraft PRO sets a new benchmark in whole-blood wound care solutions, boasting a swift procedure time and eliminating the need for blood transfer via a centrifuge or needle.
RedDress emerges as a pioneering force of the New technology that heals wounds using patients’ blood.. The company’s innovative suite of ActiGraft products has initiated a transformative wave in the field of wound care, addressing a diverse spectrum of persistent wounds that include diabetic ulcers, neuropathic ulcers, venous ulcers, pressure injuries, traumatic wounds, post-surgical wounds, skin tears, and surgical wounds, among others. This comprehensive array of ActiGraft wound care systems is now accessible in more than 30 countries spanning five continents, extending their impact across the globe. Notable nations encompassed within this network encompass Brazil, Canada, Hong Kong, India, Mexico, Turkey, United Arab Emirates, South Africa, Ireland, Italy, and many more. Founded in 2009 with an ambitious vision, RedDress originated with a mission to redefine the landscape of wound treatments. By harnessing the inherent potential of whole-blood technology, the company’s establishment was grounded in a dedication to pioneer natural and efficacious remedies for chronic wounds. With a strategic presence in Israel and a subsidiary named RedDress Inc. situated in Jacksonville, Florida, the company’s private ownership underscores its commitment to revolutionizing wound management. RedDress envisions its whole-blood technology not just as a solution for chronic wounds, but as a gateway to address a broader spectrum of human ailments.
Dehiscence and infection of hard-to-heal surgical wounds which increases medical complications and mortality rate. A hard-to-heal surgical wound will suppress the levels of factors that cause growth in humans and increase the level of debris and matrix metalloproteinases which can destroy the extracellular matrix (ECM). Also, surgical wounds in patients with comorbidities may fail to initiate the natural wound healing process which can cause the deterioration of the wound into a situation that may cause infection and amputation of the affected limb. These worries lead to the major reason why RedDress invented ActiGraft to heal surgical wounds or hard-to-heal wounds using the patient’s blood. This new invention was found to be an effective approach helping reduce the risk of infection and ensure fast wound closure and healing process.
The ActiGraft is an autologous whole blood clot, created at the point of care to promote wound healing and granulation over skin defects, and it can take place in an outpatient setting. The blood clot is created from the patient’s peripheral blood and prepared into a whole blood clot matrix. The autologous whole blood clot incorporates itself into the surrounding tissue, encompassing any skin defects in the area to which it is applied. The autologous whole blood clot supports wound hemostasis by taking the form of a blood clot which eliminates debris and drainage consisting of blood, purulence, and serous fluid. The blood clot forms a matrix that is used as a scaffold to assist in the reconstruction of the ECM as a means of attracting and allowing adhesion of necessary growth factors, such as platelet-derived growth factor (PDGF); fibroblast growth
factors (FGF); epidermal growth factor (EGF); vascular endothelial growth factor (VEGF); insulin-like growth factor (IGF); and transforming growth factor (TGF), to enhance and accelerate the wound into subsequent phases of the wound healing process.
Phases of the wound healing process. It has been shown That an exterior blood clot helps in controlling microbial Infection. The fibrin in the clot plays a pivotal role in Controlling infection at injury sites, forming a barrier That delays bacterial infiltration and movement into the Wound, as well as slowing bacterial proliferation. The scaffold also assists in protecting the wound While the body removes debris from the wound bed, Producing oxygenation and nutrients via angiogenesis Of the wound bed through VEGF, and coalescence of Wound edges through granulation during tissue Regeneration to provide complete wound Closure or closure of overexposed structures. Once in The proliferative phase, the scaffold recruits endothelial Cells and fibroblasts to ultimately construct a permanent ECM. During this phase, a continuation of granulation Occurs to fill skin defects and provide coalescence of Cutaneous wound edges. Once this has been achieved, The blood clot dries and forms a scab, which then acts As a protective barrier by allowing the cutaneous tissue Underneath to properly remodel. Patients or their legally Authorized representatives gave written informed consent before the patient participated in the study, And this covered all of the patient’s medical history, Wound properties, and wound images for Publication.
The wound-healing cascade is an organized process, involving many cells in the area of the wound, enabling it to go through the four phases of wound healing: hemostasis, inflammation, proliferation, and remodeling. Secretion of growth factors such as TGF-8, FGE, EGF, PDGF, and VEGF takes place with integration into the wound bed. The attraction of neutrophils has a major role in reducing bacterial bioburden and introducing monocytes into the wound. This creates homeostasis in the wound area and promotes wound healing The most common wound complication is the elevation of the inflammatory response, especially macrophages. Simultaneously, increased secretion of MMPs occurs, causing a breakdown in the ECM. This results in inhibition of the PDGF, TGF-B, and VEGF secretion, preventing the wound from progressing to the proliferative phase. Macrophages play a major role in wound healing by secreting pro-inflammatory cytokines that are necessary for the initiation of the inflammatory phase. This is mediated by MI macrophages. However, progression toward the proliferative phase is a result of the transition of M1 macrophages into M2 anti-inflammatory macrophages. In hard-to-heal wounds, this transition fails, maintaining the wound in the inflammatory and hard-to-heal phase. 15 In this study, the autologous whole blood clot, created in a point-of-care setting, was found to be safe and effective in treating hard-to-heal wounds of the lower extremities. The autologous whole blood clot creates a scaffold that acts as an ECM, reestablishing the communication between the cells in the wound environment.” The ECM contains multiple noncellular scaffold proteins (Le., collagen, elastin, fibronectin, and proteoglycans), glycosaminoglycan, polysaccharides, and water, which provide not only physical infrastructure but also act as a regulator of cellular activity with the cells in the wound area. The autologous whole blood clot was suggested to influence the transition of macrophages from an M1 to M2 characteristic, reducing MMP levels in the wound area and causing the wound to progress toward healing.
Blood was withdrawn from the patient into acid citrate Dextrose adenine (ACDA) vacuum tubes The blood will be then gently mixed with a Calcium coagulant and kaolin in a coagulation mold To create a blood clot, which took approximately Eight minutes. The clot was then attached to the wound bed using steri-strips and was covered with a Non-adherent dressing. A secondary hydrophilic foam
The dressing was used on top of the non-adherent pad. And Re-application was performed weekly.
Reports had it that A 72-year-old female patient with multiple comorbidities that included type 2 diabetes, osteoarthritis, osteoporosis, chronic renal failure, hypertension, artery disease, obesity, PVD, and chronic obstructive pulmonary disease, underwent a transmetatarsal amputation of the left foot. Following the amputation, the wound failed to progress towards healing, resulting in wound dehiscence and an overall wound bed area of 37cm². Wound VAC treatment was applied with no improvement and a recommendation of a BKA was made. Autologous whole blood clot treatment (ActiGraft) was introduced to the wound as a last option before the BKA. Following autologous whole blood clot application, signs of tissue granulation were observed and an improvement in the wound was noted weekly until a complete closure was achieved. Debridement was also performed each week before applying a new clot. The autologous whole blood clot was applied nine times over 10 weeks and resulted in complete wound closure also another patient, having had a cesarean section, presented with a two-week-old, hard-to-heal surgical wound in the lower abdomen. The patient had folic acid deficiency, iron deficiency, and obesity. Pemphigus Vulgaris, chronic skin tag, and fibromyositis. The patient was treated with a wound VAC, with no improvement. Autologous whole blood clot treatment (ActiGraft) was introduced once to the wound bed area resulting in complete wound closure on the same day.
In summary, The ActiGraft was found to be safe and effective in treating hard-to-heal wounds of the lower extremity, causing the wound to progress from a hard-to-heal inflammatory phase to the proliferative phase of the wound healing cascade. The autologous whole blood clot promotes cell granulation and has been shown to have a high benefit in surgical wounds, not only by initiating the natural wound healing properties but also by preventing wound infection, reducing the risk for any postoperative complications. Autologous whole blood clot as a point-of-care treatment has the potential to reduce hospitalization time, lowering the burden on the health system and, as an autologous treatment, showing a high safety pattern, reducing any negative implications that may arise due to immunological rejection. But there is a need to conduct a large study with more patients to evaluate the statistically significant efficacy of the ActiGraft whole blood clot in surgical cases. Moreover, the registry currently carried out, only included patients treated with the autologous whole blood clot(ActiGraft )and comparison group data were not available. In conclusion, autologous whole blood clot treatment (ActiGraft) showed high efficacy in promoting delayed wound healing, contributing to the improvement of the patient health and recovery process.
