Status:
COMPLETED
Split Thickness Donor Site Healing With MIST Study
Lead Sponsor:
Celleration, Inc.
Conditions:
Burns
Trauma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Subjects requiring skin grafting due to burns, trauma, or chronic venous ulcers with split thickness donor sites expected to be between 20 and 200 square cm will be consecutively screened for study el...
Detailed Description
Enrolled subjects will be randomized to receive one of two treatment courses: a) MIST Therapy in conjunction with standard of care (SOC) (treatment group); or b)SOC alone (control group). On post-op ...
Eligibility Criteria
Inclusion
- Male or female subject of any race and at least 18 years old
- Subject requires skin grafting
- Subject's wound must be between 20 cm2 and 200 cm2
- Subject's wound presents with no clinical signs of acute infection
- Subject has ahd no prior MIST Therapy to the enrolled wound
- Subject or subject's legally authorized representative understands the nature of the procedure(s) and provides written informed consent prior to study enrollment
- Subject is willing and able to comply with all specified care and visit requirements
- 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
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 subject 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
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01214980
Start Date
February 1 2012
End Date
July 1 2014
Last Update
December 19 2014
Active Locations (1)
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1
Tampa General Hospital
Tampa, Florida, United States, 33606