Elastic Compression of Bioengineered Human Skin Substitute Improves Chronic Ulcer Healing: Fuzzy Yarn Compression Controls Wound Bed Edema

Painful Bilateral Diabetic Ulcers Ischemic Ulcer Recurrent Stasis Ulcer Stasis Ulcer

Insulin dependent diabetic treated 5 Right 5th metatarsal head ulcer is A veteran of the U.S. Army Air Corps who months in a rural hospital wound center accompanied by extensive edema. served in occupied Japan has had a 10 month with medical honey. Recurrent painful left leg stasis unrequited relationship with a local wound care ulcers make the patient miserable. center. Enzyme debridement had not been effective. Pedal pulses were present. Patient takes Prednisone 5mg daily for COPD. Problems Problems • Recurrent R foot ulcers • Diabetic, on insulin Problems Problems Wounds at rst clinic visit. Note how thin the skin appears. Patient is on Prednisone for COPD. Note • No healing progress over 7 months edema of the surrounding skin. • Lateral ankle ulcers • Recurrent L leg stasis ulcers • Venous insufficiency • Paraplegia • Poorly controlled diabetes Wounds at rst clinic visit. Wounds Foot is deformed due to paraplegia. Foot is painful • Pedal pulses present • have been treated with collagenase due to ischemia from aorto-iliac and femoral- at another wound clinic for several popliteal atherosclerotic occlusions. Observe the months. Wounds were weeping lymph • NPWT x 2 months heavy bioburden, heavy exudates, extensive edema  uid. Note severe stasis . and erythemia suggesting . Two surgeon • Healing stalled in spite of Left ankle lateral ulcers present for 5 months. Treated at Week two of therapy, severe stasis dermatitis • On Prednisone for emphysema The shiny red skin re ects light and consultants recommend R BK Amputation. community wound center with honey dressing. Observe with weeping serum and heavy bioburden. has a glassy appearance because shiny edematous granulation tissue, macerated skin • Atherosclerosis, absent pedal pulses of edema  uid in the dermis that community wound center edges, transparent skin around wounds and adherent refracts the re ected light. brin bioburden. Bacteria in the thick bio lm are likely therapy with use of honey for culprits for stalled healing. • L BKA, Refuses R BKA.

5 months HEMA nanoparticle powder is applied between Longitudinal Yarn Compression textile yarns after weekly wound debridement. Acoustic powered debridement of painful lateral ankle diabetic ulcer cleans up brinoid bioburden. Severe stasis dermatitis with weeping serum and heavy bioburden.

Longitudinal Yarn Compression (LYC) textile directly compresses the granulation wound surface as the rst layer of a four layer dressing. Rx • Longitudinal Yarn Compression as the Note the cornrow furrows in the skin Rx ( ) surrounding the healing stasis ulcers. Incomplete debridement of wounds at rst clinic visit with rst layer of a four layer dressing ***** . scalpel and curette. Patient was acutely short of breath and Rx debridement was halted. • Longitudinal Yarn ( ) • HEMA nanoparticle gel(****). • Bioengineered human skin substitute * Compression(*****) textile for ( ) Note LYC stockinet is in direct contact with • Bioengineered human skin substitute (*). treatment of stasis dermatitis for • Hypochlorous acid solution lavages ** the granulation surface. LYC is layer one of a Rx four layer dressing. 11 weeks. Note cornrow furrows in the skin ( ) • Weekly mechanical control of bio lm with around the ulcers. Fuzzy Yarns in • Acoustic powered *** debridements • Compression with Longitudinal Longitudinal Yarn Compression (LYC) ( ) LYC stockinet was placed directly on granulation ulcers. Note gauze textile creates furrows in the skin. ( ) Hypochlorous acid solution ** and 22.5 • Sharp and later Acoustic is on top of the stockinet yarns, held in place with nylon stockings. ( ) Ultrasonic powered debridement at 7 weeks Yarn Compression ***** (LYC) • HEMA Nanoparticle Power dressings **** ( ) of compression therapy. ( ) Longitudinal Yarn Compression textile creates KHz ultrasound debridement *** . powered *** weekly furrows in wound granulations. Note decrease in textile for four months to control ( ) edema and skin redness with LYC therapy. LYC debridements. • Longitudinal Yarn Compression Textile ***** compression appears to increase skin perfusion. severe stasis dermatitis. HEMA powder dressing helped control wound pain. Note the cornrow furrows in the granulation wound. • Bioengineered human skin • Two applications of ( ) substitute * . For the primary Bioengineered Human Skin dressing, LYC was used as the ( ) Bioengineered Human Skin Substitute Substitute * . LYC textile was used HEMA nanoparticle gel on granulating surface. placed after 15 weeks of yarn focused Note improved appearance of skin. rst layer of a four layer dressing. compression with LYC stockinet. Note how robust the skin appears after as a primary dressing after the clearing the dermatitis with compression. Note also the cornrow furrows in the skin surrounding the ulcers. second BeSS application. Bioengineered Human Skin Substitute (BeSS) is placed after 7 weeks of compression with fuzzy yarn. Polyester gauze** protects BeSS. Longititudinal Yarn Compression (LYC) stockinet is the base layer of a four Outcome Outcome layer dressing. LYC speeds healing of the BeSS graft. 5th metatarsal head ulcer healed 3 week after Bioengineered • Ulcers healed with 12 weeks of • Rapid 85% healing ischemic ankle ulcer human skin substitute. Outcome Longitudinal Yarn Compression and after BeSS grafting. • Nanoparticle Polymer Powder Gel Controls bioburden control Outcome • Failed mid-foot split thickness skin graft. Ulcer Pain • Ulcers healed 9 weeks after • LYC stockinet treats stasis dermatitis. • Complete healing 5th metatarsal head ulcer. • Longitudinal Yarn Compression Stockinet Bioengineered Human Skin Substitute • Wounds heal seven weeks after human (LYC) in Direct Contact with Granulation • Good control of pain. Extensor surface ulcer is 9 weeks post split thickness wound center pinch skin graft. Note the skin substitute. Tissue Speeds Healing pinch graft failed while the bioengineered human skin substitute healed the other two ulcers. • Ulcers Healing, at Time of Publication, After Left leg CSU’s “healed” after LYC for 7 months and two applications of BeSS. Wounds are 97% healed seven weeks after BeSS. Note skin cornrow furrows in the granulating wounds. 17 Days of Longitudinal Yarn Compression. Ankle Ulcer 80% healed 7 weeks post BeSS. Note how robust the skin looks as a result of Longitudinal Complete healing 9 weeks after bioengineered human skin substitute. Yarn Compression textile.

Elastic Compression of Bioengineered Human Skin reported improved split thickness skin graft healing when yarn focused elastic compression healing rates with Bioengineered Skin Substitute. is applied at the rst dressing change.(4) Legend Authors: Substitute Improves Chronic Ulcer Healing: Fuzzy Yarn References: Compression Controls Wound Bed Edema This study answers two questions about BeSS therapy for CSU: Is YFC textile a feasible (1) Espensen, EH, et al. “Use of subatmospheric (VAC) therapy to improve bioengineered and safe primary dressing for CSU treated with BeSS? Does the control of healing wound * Apligraf ®, Organogenesis, Canton, MA tissue grafting in diabetic foot wounds.” Journal of the American Podiatr. Med. Assoc. 92(7): Martin J. Winkler, MD, FACS Introduction: Lymphatic insufficiency accompanies Chronic Stasis Ulcers (CSU), surface edema with Yarn Focused Compression improve BeSS healing? creating an edematous wound hostile to skin graft healing. Bioengineered skin substitute 395-397, 2002. ( ) ** Vashe® Wound Therapy, PuriCore, Malvern, PA (BeSS) (*) reliably “heals” CSU hostile wound beds that wound not “take” a split thickness Methods: Four patients with skin ulcers of mixed etiology, were treated with BeSS * held (2) Kozeny, D., Stott, K. “Longitudinal yarn compression textile: An innovative treatment for leg ( ) ( ) ( ) National Science Foundation Steven L. Clinch, MD, FACS skin graft. Negative wound pressure therapy (NWPT), and three layer compression in place with nanoparticle hydrogel ** , a thin polyester mesh ****** and YFC textile ***** as a swelling.” Journal of Vascular Nursing, Volume 25, Issue 3, Pages 62-62, September 2007. fuzzy compressive rst layer of a three layer dressing. Grant Award Number 0650233 ® dressings speed healing of hostile wounds treated with BeSS, presumably by controlling *** SonicOne , Misonix, Farmingdale, NY (3) Landon, Laura, et al. “Controlling wound edema with fuzzy yarn focused elastic pathological edema at the wound surface.(1) Karla A. Manzel, BSN, MS, CWON, FCN Results: YFC compression textile was well tolerated. Ulcer healing is documented in compression in direct contact with granulation tissue speeds healing.” Clinical Symposium on photos. Dislodgement of the dressing protecting the BeSS was the only complication. **** Altrazeal™, Uluru Corporation, Addison, TX Yarn Focused Compression (YFC) textile creates cornrow furrows in the subcutaneous Advances in Skin & Wound Care Abstract October 2009. beneath fuzzy yarns. YFC, at a physiological level, is a novel elastic compression Lindsey Manzel, BS Conclusions: Elastic compression of BeSS grafted ulcers with Yarn Focused (4) Maloley, Brittney J., et al. “Improved skin graft maturation and cosmesis with yarn focused ® textile for edema control.(2) Landon delivered yarn focused elastic compression, with YFC Compression textile appears to be comfortable and safe. Controlling healing surface edema ***** EdemaWear , Compression Dynamics, LLC, Omaha, NE elastic compression.” American College of Surgeons, Poster Session, October 2009. resting directly on granulating CSU surface and showed increased healing.(3) Maloley that accompanies stasis ulcers with Yarn Focused Compression textile may improve ulcer