Comparative Effectiveness Study of MIST Therapy Versus Negative Pressure Wound Therapy

Withdrawn before enrolling · Phase 4

Conditions studied: Wounds

In brief

The purpose of this study is to evaluate the clinical and economic effectiveness of MIST Therapy vs NPWT vs MIST Therapy in conjunction with NPWT in the treatment of full thickness wounds presenting in the LTACH and SNF settings.

Key facts

Study ID

NCT01200563

Run by

Celleration, Inc.

People needed

0

Starts

2010-08-01

Expected to finish

2011-07-01

Last updated by the study team

2014-12-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subject of any race and at least 18 years old
• Subject presents with full thickness wound of any etiology
• Subject's wound is between 20cm2 and 250cm2
• Subject's wound has less that 20% necrotic tissue
• Subject is nutritionally stable and/or taking nutritional supplements and is being followed by a dietician
• Subject or subject's legally authorized representative understands the nature of the study procedure(s) and provides written informed consent prior to study enrollment
• Women of childbearing potential must not be pregnant or lactating, and must be using adequate and accepted contraceptive methods
• Subject has a reasonable expectation of completing the study
• Subject has had no prior MIST Therapy or Negative Pressure Wound Therapy to the enrolled wound

You may not qualify if…

• Subject's condition requires the use of topical antibiotics at the time of study enrollment
• Subject's wound would require ultrasound near an electronic implant or prosthesis, e.g., near or over the heart, or over the thoracic area if the patient is using a cardiac pacemaker
• Subject is known to be suffering from a disorder or other situation that the subject or investigator feels would interfere with compliance or other study requirements
• Subject is currently enrolled or has been enrolled in the last 30 days in another investigational device or drug trial
• Subject has a combination of medical condition(s) that in the opinion of the investigator would make the subject an inappropriate candidate for the study, i.e., diabetes, including renal, hepatic, hematologic, neurologic, or immune disease
• Subject's wound is not appropriate for Negative Pressure Wound Therapy or MIST Therapy
• Subject has osteomyelitis, systemic sepsis, or an infection not related to his/her index wound (e.g., UTI, pulmonary) that has been untreated or has not been appropriately managed
• Subject has a fistula(s) to the index wound bed
• Subject's index wound is a head or neck wound
• Subject's index wound presents with a malignancy in the wound bed
• Subject's anticoagulation therapy is unstable
• Subject is undergoing chemotherapy

Where it is running

• Trillium Specialty Hospital — Mesa, Arizona, United States

Full record on ClinicalTrials.gov

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