Comparative Effectiveness Study of MIST Therapy Versus Negative Pressure Wound Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01200563|
Recruitment Status : Withdrawn (Study site compliance)
First Posted : September 13, 2010
Last Update Posted : December 15, 2014
|Condition or disease||Intervention/treatment||Phase|
|Wounds||Device: MIST Therapy Device: Vacuum Assisted Closure Device: MIST Therapy and Negative Pressure Wound Therapy||Phase 4|
A comparative, prospective, randomized study.
Study objectives: Comparison between study groups of the assigned study treatment's effect on the rate of wound healing, cost per episode of care, severity of wound pain, and the occurrence of adverse events.
Subject recruitment: Consecutive, prospective subjects admitted to the study site will be screened for study enrollment and potential randomization. Prospective data will be collected on study subjects until at least 10 subjects are randomized into each of three treatment groups: MIST Therapy; NPWT; or MIST Therapy and NPWT.
Protocol and procedures: All randomized subjects will continue to receive standard of care treatment appropriate for their wound for the duration of their study treatment regardless of their assigned treatment group. Subjects will continue to receive assigned study treatment as long as their wound continues to show improvement, as determined by the investigator. Study treatment will continue until wound closure, or for up to 6 weeks without wound closure. A baseline evaluation will include a medical history assessment, VAS pain score, wound history and evaluation including: wound dimension measurements, overall wound assessment, digital photography, and appropriate sharp debridement, if necessary. Weekly wound assessments will include a wound evaluation, digital photography and VAS pain score. Prospective data will also be collected on specific wound care supplies and interventions provided. These data will be tracked as interventions occur while the wound continues to be treated with the assigned study treatment. Economic data will include type, quantity, duration, associated frequency, and professional time requirements.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparative, Prospective, Randomized Study of MIST Therapy vs NPWT vs MIST Therapy in Conjunction With NPWT on the Rate of Healing and Its Economic Value in the Treatment of Full Thickness Wounds in a LTACH and SNF|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||July 2011|
Active Comparator: Group 1
Subjects assigned to receive MIST Therapy will be treated 3 times per week. The duration of each MIST treatment will be dependent on the wound's area measured at baseline and at each weekly assessment.
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.
Other Name: MIST
Active Comparator: Group 2
Subjects assigned to receive Negative Pressure Wound Therapy will be treated with the Vacuum Assisted Closure system. For administration of this study treatment, e.g., treatment cycle, target pressure and dressing changes, the manufacturer's recommended guidelines will be followed.
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.
Other Name: VAC Therapy
Active Comparator: Group 3
Subjects assigned to this group will receive MIST Therapy treatments and Negative Pressure Wound Therapy.
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.
- Rate of wound healing. [ Time Frame: 6 weeks ]Determined by the change in wound surface area/volume from the initial evaluation date to study end.
- Change wound exudation levels. [ Time Frame: 6 weeks ]Determined by the change in amount of exudates recorded using a scale of none, mild, moderate, and heavy, from the initial evaluation date to study end.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01200563
|United States, Arizona|
|Trillium Specialty Hospital|
|Mesa, Arizona, United States, 85206|
|Principal Investigator:||Kenneth O Anaeme, MD||Trillium Specialty Hospital|