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

NCT03283787 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-04-20

Study results available
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Summary

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

Conditions

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

Interventions

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

Sponsors & Collaborators

  • St Vincent's Hospital

    collaborator OTHER

  • Integra LifeSciences Corporation

    lead INDUSTRY

Principal Investigators

  • Carol Bowen-Wells, MD · Saint Vincent's Medical Center Riverside

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-01
Primary Completion
2019-09-25
Completion
2019-12-23
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03283787 on ClinicalTrials.gov