Status:
WITHDRAWN
Comparative Effectiveness Study of MIST Therapy Versus Negative Pressure Wound Therapy
Lead Sponsor:
Celleration, Inc.
Conditions:
Wounds
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 i...
Detailed Description
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, severi...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01200563
Start Date
August 1 2010
End Date
July 1 2011
Last Update
December 15 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Trillium Specialty Hospital
Mesa, Arizona, United States, 85206