Split Thickness Donor Site Healing With MIST Study (NCT01214980) | Clinical Trial Compass
CompletedNot Applicable
Split Thickness Donor Site Healing With MIST Study
United States32 participantsStarted 2012-02
Plain-language 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 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of Wound Healing
Timeframe: Days to absence of drainage from the initial donor site harvest procedure