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Bioatrix Phase I/II Trial Results • Wounds involving bone, joint or metalware exposure • All had osteomyelitis and receiving Topical Negative Pressure (TNP) treatment • TNP device removed • Wound measured • APC applied: • 1-3 ml APC (400 ug/ml) • shallow injections in periphery • TNP is re-applied Aruna Wijewardana, Elle Vandervord, Sepehr Lajevardi, John Vandervord, Christopher Jackson, Combination of activated protein C and topical negative pressure rapidly regenerates granulation tissue over exposed bone to heal recalcitrant orthopaedic wounds. Int J Lower Extrem Wounds, 2011, in press.
Bioatrix Phase I/II Trial Results - Patient 1 • • • • • 48 year old male Fracture in his left tibia in 1980 Bone defect at fracture site Osteotomy and bone graft performed in 2005.
Immediately developed osteomyelitis with a deep chronic ulcer on left shin.
Bioatrix Phase I/II Trial Results - Patient 1
Bioatrix Phase I/II Trial Results - Patient 2 • • • • • • • • 24 year old female No sig co-morbidities Motor vehicle accident – sustaining multiple fractures L metatarsal fracture fixed with plates and screws Post op infection and wound breakdown Metal-ware could not be removed due to low stability of underlying bone Skin grafting not possible due to exposed screws, tendon and bone. Flap reconstruction exposed metal-ware high risk of failure due to
Bioatrix Phase I/II Trial Results - Patient 2
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Bioatrix Phase I/II Trial Results - Patient 3 • • • • • 39 year old female PMHx: Severe Rheumatoid Arthritis Bilateral hip replacements due to degeneration Sacral pressure sore following prolonged hospitalisation Wound non-healing for 2 years with conventional dressings and debridement and TNP application
Bioatrix Phase I/II Trial Results - Patient 3
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Bioatrix 4. Phase I Trial Results - Patient 4 • • • • • • 47 year old male No sig co-morbidities Tibial fracture after being hit with baseball bat - required open reduction and fixation with plates and screws Post op infection and wound break down Chronic osteomylitis and removal of metal-ware Failure of wound closure after 2 years of various conventional dressings and TNP
Bioatrix Phase I/II Trial Results - Patient 4
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Bioatrix 4. Phase I Trial Results - Patient 5 • • • • • • • 55 year old male Sports injury 32 years ago with dislocated knee and rupture of popliteal artery and tibial fracture.
Vessels repaired - subsequently developed compartment syndrome and necrosis of the anterior compartment.
Necrotic tissue was debrided and wound healed after 12 months.
Skin remained intact until 12 month prior to presentation where he sustained a laceration across the old scar and developed an infection. Despite continued antibiotics treatment, he developed osteomyelitis. Continued antibiotics, frequent dressings and TNP. The wound however increased in size and he developed multiple abscesses.
Bioatrix 4. Phase I Trial Results - Patient 5