Split Thickness Donor Site Healing With MIST Study
Completed · Not applicable
Conditions studied: Burns, Trauma, Venous Ulcers
In brief
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 eligibility. This study is a prospective, randomized, controlled trial evaluating effect of MIST Therapy on the healing of split thickness skin graft donor sites compared to standard care. Subjects meeting all eligibility criteria and providing appropriate written informed consent will be enrolled for study participation.
Key facts
- Study ID
- NCT01214980
- Run by
- Celleration, Inc.
- People needed
- 32
- Starts
- 2012-02-01
- Expected to finish
- 2014-07-01
- Last updated by the study team
- 2014-12-19
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 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
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 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
Where it is running
- Tampa General Hospital — Tampa, Florida, United States
Full record on ClinicalTrials.gov
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