N/A
N=32
Split Thickness Donor Site Healing With MIST Study
Burns · Trauma · Venous Ulcers
Bottom Line
View on ClinicalTrials.gov: NCT01214980 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: Rate of Wound Healing — 12.1; 21.3 Days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MIST Therapy (Device); Standard of care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Celleration, Inc.
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Wound Healing |
12.1; 21.3 | — |
| SECONDARY Time to Full Epithelialization |
18.2; 27.5 | — |
| SECONDARY Numeric Pain Score |
0; 1.8 | — |
| SECONDARY Numeric Itching Score |
0.7; 4.1 | — |
| SECONDARY Donor Site Recidivism Rate |
1; 5 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01214980). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.