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Mist Ultrasound: The Results of a Prospective, Non‐Randomized Efficacy Study of Recalcitrant Wounds
Author(s) -
Ennis William J.,
Gainer Marianne,
Meneses Patricio
Publication year - 2008
Publication title -
wound repair and regeneration
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.847
H-Index - 109
eISSN - 1524-475X
pISSN - 1067-1927
DOI - 10.1111/j.1067-1927.2005.130216ax.x
Subject(s) - medicine , mist , surgery , clearance , clinical endpoint , debridement (dental) , clinical trial , wound healing , randomized controlled trial , urology , physics , meteorology
MIST ultrasound, a recently FDA‐cleared noncontact ultrasound therapy, was utilized prospectively in an IRB‐approved trial for the treatment of recalcitrant wounds of various etiologies. Twenty‐nine wounds from 23 patients were studied. Inclusion criteria included wounds greater than 4 weeks duration with no evidence of clinical improvement (>15% area reduction) over the prior 2 weeks before enrollment. The wounds were required to be free from clinical signs of infection. After an initial debridement and wash‐out period, patients were treated 3 times a week with MIST for 4 minute treatment applications. Dressing regimens were left up to the investigator as dictated by wound conditions. The primary endpoint is complete healing. Data will be presented looking at MIST‐derived healing, as defined by complete healing using MIST therapy all the way to closure. MIST‐assisted healing, as defined by MIST therapy for wound bed preparation followed by an alternative means of closure will also be presented. “Overall healing” defined by the combination of the two prior groups will complete the outcomes report, as this reflects a more “real‐world” clinical application for the technology. Wound dynamics, Kaplan Meier survival plots and laser Doppler imaging estimations of angiogenesis will all be presented. Acknowledgment: This study was supported with a grant from Celleration Inc., Eden Prairie, MN.