The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, randomized trial in which pressure ulcers will be treated using Aurix and standard care and compared 1:1 to patients receiving undefined Usual and Customary Care.
Pressure ulcers (PUs) are a common problem in all patient care settings, especially long-term acute care facilities and nursing homes. Aurix is a platelet-rich plasma gel used in the treatment of non-healing chronic wounds. The results of Aurix to date when used to treat PUs have been promising. The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, randomized trial in which pressure ulcers will be treated using Aurix and standard of care to determine time to heal at 16 weeks. Comparison will be made to patients receiving undefined Usual and Customary Care in a 1:1 manner.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
800
Aurix is a platelet-rich plasma gel used in the treatment of non-healing wounds. It will be administered twice weekly for 2 weeks then weekly.
Time to Heal
Compare complete wound healing at 16 weeks for all pressure ulcers treated with Aurix plus standard of care with patients randomized to usual and customary care. Complete wound closure is defined as skin re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart (FDA Guidance for Industry Chronic Cutaneous Ulcer and Burn Wounds - Developing Products for Treatment, 2006).
Time frame: 16 weeks
Proportion of healed ulcers
Proportion of patients with completely healed pressure ulcers
Time frame: 16 weeks
W-QOL (Quality of Life with Chronic Wounds) score
Change in mean W-QOL (Quality of Life with Chronic Wounds) score between baseline and 16 weeks
Time frame: 16 weeks
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