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MIST Therapy's Effectiveness in Wound Bed Preparation and Role of Bacterial Biofilm in Chronic, Non-healing Wounds

NCT01125735 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2013-07-02

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effectiveness of MIST Therapy in combination with standard of care (SOC) compared to SOC alone on reducing the bacteria in your wound and preparing the wound bed for surgical closure in patients that have chronic, non-healing wounds.

The MIST Therapy System delivers therapeutic ultrasound to the wound bed without direct contact. Saline solution is converted into fine particles and released towards the wound by sound pressure waves to remove dead or damaged tissue. The MIST Therapy System is currently the only FDA cleared non-contact ultrasound device to promote wound healing.

Standard of care procedures include surgical debridement of the wound in the operating room to remove all infected, dead tissue and bone.

This research is being done because the investigators do not know which of these commonly-used treatments is better, and because the investigators would like to evaluate the bacteria that is present in the wound.

Conditions

  • Chronic Nonhealing Wounds

Interventions

DEVICE

MIST Therapy

The MIST Therapy System is designed to deliver therapeutic ultrasound to the wound bed without direct contact of the device to the body (noncontact). The system generates and propels the therapeutic MIST Therapy towards the tissue. The saline solution is directed to the tip surface and is atomized through the vibration of the tip surface. This surface creates atomization of the fluid, breaking it apart into small particles of uniform size. Once the particles of fluid are released from the tip, a second phenomenon, the acoustic pressure wave, drives them toward the wound.

OTHER

Standard of Care

Standard of Care with saline rinse using a sham device which is a nebulizer compressor designed to deliver a continuous saline mist to a skin treatment site. The saline mist generated has been designed to be comparable to that delivered by the MIST Therapy System, but without the ultrasound waves.

Sponsors & Collaborators

  • Celleration, Inc.

    collaborator INDUSTRY

  • Georgetown University

    lead OTHER

Principal Investigators

  • Christopher Attinger, MD · Georgetown Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2012-06-30
Completion
2014-04-30

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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 NCT01125735 on ClinicalTrials.gov