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

PHASE4WithdrawnINTERVENTIONAL
0
Timeline

Start Date

April 30, 2011

Primary Completion Date

June 30, 2012

Study Completion Date

April 30, 2014

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 (1)

All Listed Sponsors
collaborator

Celleration, Inc.

INDUSTRY

lead

Georgetown University

OTHER