MedTrace Logo

Epidermal Coverage of Traumatic Wound Injuries Via Use of Autologous Spray Skin Applied Over Bilayered Wound Matrix

NCT02469168 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2018-08-07

Study results available
· View outcomes & findings →

Summary

The purpose of this investigation is to evaluate the safety, tolerability, preliminary and long-term effectiveness of utilizing the ReCell Autologous Cell Harvesting Device (ReCell) combined with widened split-thickness skin graft (STSG) mesh onto the dermal regenerate INTEGRA™ Meshed Bilayer Wound Matrix (MBWM) for healing of full-thickness wounds.

Conditions

  • Wounds and Injury

Interventions

DEVICE

Recell

ReCell Treatment over wound pretreated with INTEGRA™ MBWM Wound Matrix

PROCEDURE

Control

Standard meshed split thickness skin graft over wound pretreated with INTEGRA™ MBWM Wound Matrix

Sponsors & Collaborators

  • University of Pittsburgh

    collaborator OTHER

  • Rubin, J. Peter, MD

    lead OTHER

Principal Investigators

  • Leon J Nesti, PhD · Walter Reed National Military Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT02469168 on ClinicalTrials.gov