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

This study has been withdrawn prior to enrollment.
(Contract negotiations were terminated and study never started.)
Sponsor:
Collaborator:
Celleration, Inc.
Information provided by (Responsible Party):
Christopher Attinger, M.D., Georgetown University
ClinicalTrials.gov Identifier:
NCT01125735
First received: May 17, 2010
Last updated: July 1, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Chronic Nonhealing Wounds
Device: MIST Therapy
Other: Standard of Care
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled Study of MIST Therapy's Effectiveness in Wound Bed Preparation and the Role of Bacterial Biofilm in Subjects Presenting With Chronic, Non-healing Wounds

Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • Rate of Healing [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Role and Presence of biofilm [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    To evaluate the role and presence of biofilms in chronic wounds in persons with ESRD undergoing MIST therapy as compared to the control group and to evaluate if the presence of a biofilm is reflected in the quantitative wound culture


Enrollment: 0
Study Start Date: April 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MIST Therapy
MIST Therapy is a low energy, low intensity ultrasound delivered through a saline mist to the wound bed.
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 Name: MIST Therapy
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.
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.
Other Name: Standard of Care

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

OR

  • Subject's wound presents with acute gangrene or massive tissue loss that does not meet the 30 day criteria.

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01125735

Sponsors and Collaborators
Georgetown University
Celleration, Inc.
Investigators
Principal Investigator: Christopher Attinger, MD Georgetown Hospital
  More Information

No publications provided

Responsible Party: Christopher Attinger, M.D., Chief of the Division of the Center for Wound Healing, Georgetown University
ClinicalTrials.gov Identifier: NCT01125735     History of Changes
Other Study ID Numbers: 2010-093
Study First Received: May 17, 2010
Last Updated: July 1, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 01, 2014