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

Pressure Ulcer Clinical Trial

Official title:
A Single Site Randomized, Clinical Trial Comparing the Concomitant Use of MicroMatrix® With Cytal™ Wound Matrix 2-Layer to Standard of Care in Patients With Stage 3 or 4 Pressure Injuries

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03283787
Study type Interventional
Source Integra LifeSciences Corporation
Contact
Status Completed
Phase N/A
Start date April 1, 2017
Completion date December 23, 2019
View Details
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