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Comparative Effectiveness Study of MIST Therapy Versus Negative Pressure Wound Therapy

NCT01200563 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2014-12-15

No results posted yet for this study

Summary

The purpose of this study is to evaluate the clinical and economic effectiveness of MIST Therapy vs NPWT vs MIST Therapy in conjunction with NPWT in the treatment of full thickness wounds presenting in the LTACH and SNF settings.

Conditions

  • Wounds

Interventions

DEVICE

MIST Therapy

Low-frequency, non-contact ultrasound system delivering therapeutic ultrasound via a fine saline mist to the wound bed without direct contact of the device with the body.

DEVICE

Vacuum Assisted Closure

Controlled negative pressure (vacuum) delivering negative (sub-atmospheric) pressure to the wound site applied by a tubing which decompresses a foam dressing, continuously or intermittently depending on wound type.

DEVICE

MIST Therapy and Negative Pressure Wound Therapy

MIST Therapy will be provided 3 times per week, NPWT will be provided according to the manufacturer's recommended guidelines.

Sponsors & Collaborators

  • Celleration, Inc.

    lead INDUSTRY

Principal Investigators

  • Kenneth O Anaeme, MD · Trillium Specialty Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2011-07-31
Completion
2011-07-31

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 NCT01200563 on ClinicalTrials.gov