NCT03283787

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Integra LifeSciences Corporation · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Pressure Ulcers Stage III
• Pressure Ulcer, Stage IV
• Pressure Ulcer

Interventions

Type	Name	Description
DEVICE	MicroMatrix® and Cytal™ Wound Matrix 2-Layer	MicroMatrix® and Cytal™ Wound Matrix 2-Layer
DEVICE	MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT	MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT
DEVICE	Negative Pressure Wound Therapy	Negative Pressure Wound Therapy

Timeline

• Start date: 2017-04-01
• Primary completion: 2019-09-25
• Completion: 2019-12-23
• First posted: 2017-09-14
• Last updated: 2021-04-20
• Results posted: 2020-11-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study