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

NCT01125735 | Withdrawn Phase 4

• 1 other identifier: 2010-093
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Rate of Healing

  To compare the rate of healing at 20 weeks between the MIST therapy group and the control group and to compare the clinical effectiveness between the treatment groups in achieving appropriate wound bed preparation for a delayed primary closure procedure.

  20 weeks

Secondary Outcomes (1)

• Role and Presence of biofilm

  20 weeks

Study Arms (2)

MIST Therapy

EXPERIMENTAL

MIST Therapy is a low energy, low intensity ultrasound delivered through a saline mist to the wound bed.

Device: MIST Therapy

Standard of Care

OTHER

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.

Other: Standard of Care

Interventions

MIST Therapy DEVICE

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.

MIST Therapy

Standard of Care OTHER

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.

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is at least 18 years or older.
• Subject has a chronic non healing wound located below the knee.
• Subject's wound is 5 cm2 or larger
• Subject's wound is adequately vascularized, demonstrated by SOC Doppler assessment.
• Subject must sign an institutional review board (IRB) approved informed consent.
• Subject is willing and able to complete required follow up.
• Subject's wound has been present longer than 30 days without 50% reduction in surface area in previous 30 days.
• Subject's wound presents with acute gangrene or massive tissue loss that does not meet the 30 day criteria.

You may not qualify if:

• Subject's wound requires the use of topical antibiotics at the time of study enrollment.
• subject's wound presents with a malignancy in the wound bed.
• Subject has a cardiac pacemaker or other electronic device implants.
• Subject has a disorder or situation that the investigator believes will interfere with study compliance.
• Subject is currently enrolled or enrolled in the last 30 days in another investigational device or drug trial.
• Subject is pregnant or pregnancy is suspected.
• Subject's wound is smaller than 5cm2

Sponsors & Collaborators

• Georgetown University: lead
• Celleration, Inc.: collaborator

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Christopher Attinger, MD

  Georgetown Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Division of the Center for Wound Healing

Study Record Dates

• First Submitted: May 17, 2010
• First Posted: May 18, 2010
• Study Start: April 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: April 1, 2014
• Last Updated: July 2, 2013

Record last verified: 2013-07