CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 32 enrolled
Drug / intervention
MIST Therapy +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01214980
NCT01214980N/ACompleted
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A Prospective, Randomized, Controlled Pilot Study of the MIST Therapy System for the Treatment of Split Thickness Donor Sites

Celleration, Inc.·interventional·Posted Oct 5, 2010·Updated Dec 19, 2014

In Brief

A clinical study evaluating MIST Therapy and Standard of care for Burns and 2 related conditions. Completed, enrolled 32 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBurns, Trauma, Venous Ulcers
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 5, 2010
Enrollment StartFeb 1, 2012
Primary CompletionJul 1, 2013
Study CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 15.7 years ago

Interventions

MIST Therapydevice

Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment on a daily basis for 5 days.

Standard of careother

Standard of care provided per site-specific protocol