The purpose of this study is to evaluate incidence of complete epithelialization in stage 3 \& 4 pressure ulcers using ACell products.
A three arm, parallel-design, randomized study comparing 2 experimental arms to a single control arm. The primary comparison will be Group 1 (MicroMatrix® and ACell Cytal™ Wound Matrix 2-Layer vs. Group 3 (NPWT) to determine if Group 1 is superior to Group 3. NPWT is the standard of care (SOC) for patients with Stage 3 or 4 pressure ulcers and is the active control arm for the study. A secondary comparison will be conducted comparing Group 2 (MicroMatrix® and ACell Cytal™ Wound Matrix 2-Layer plus NPWT) vs. Group 3 (NPWT) to determine if Group 2 is superior to Group 3.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
MicroMatrix® and Cytal™ Wound Matrix 2-Layer
MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT
Negative Pressure Wound Therapy
Saint Vincent's Medical Center
Jacksonville, Florida, United States
Incidence of Complete Epithelialization
Number of participant wounds with complete epithelialization by 12 weeks. Complete wound closure (epithelialization) determination based on PI assessment.
Time frame: 12 weeks
Time to Complete Wound Epithelization
Time to complete wound epithelization between groups.
Time frame: 12 weeks
Rate of Wound Epithelization
Rate of wound epithelization between groups
Time frame: 12 weeks
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