Last updated on February 2018

Comparing Concomitant Use of ACell MicroMatrix and ACell Cytal to Standard of Care in Stage 3 or 4 Pressure Injuries


Brief description of study

The purpose of this study is to evaluate incidence of complete epithelialization in stage 3 & 4 pressure ulcers using ACell products.

Detailed Study Description

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.

Clinical Study Identifier: NCT03283787

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Saint Vincent's Medical Center

Jacksonville, FL United States
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