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Sponsored by: |
University of Southern California |
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Information provided by: | University of Southern California |
ClinicalTrials.gov Identifier: | NCT00628602 |
Pressure ulcers (PUs) are a debilitating pathology resulting from pressure and shear in the soft tissues of immobilized patients. In studies to date, BION neuromuscular stimulation has been demonstrated to activate strong muscle contractions and to produce skeletal motion, with associated increases in muscle bulk (hypertrophy), strength, and metabolic capacity, hence counteracting the 3 major etiological factors in PU development (immobility, soft-tissue atrophy and hypoxia).
This study intends to use neuromuscular stimulation to both shift paralyzed subjects' weight and build up gluteal muscle volume, in order to prevent recurrence of pressure ulcers. We will implant BIONs alongside the already exposed inferior gluteal and sciatic nerves in patients who are undergoing gluteal rotation flap surgery for PU reconstruction. The gluteal rotation flap is a common reconstructive technique for treating PUs by bringing healthy muscle and skin in to repair the deficient area, and to provide healthy tissue covering over bony prominences. The implanted BIONs will enable us subsequently to stimulate the gluteus maximus and hip extensor muscles. Outcome measures will include tissue health variables (measured by clinical assessment, X-Rays, MRI and Sesta-MIBI SPECT perfusion scans), pressure redistribution (measured by an array of pressure sensors), and recurrence rates over 12 months.
Condition | Intervention | Phase |
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Pressure Ulcer |
Device: BION |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | BION Active Seating for Pressure Ulcer Prevention |
Estimated Enrollment: | 30 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Rx Group: Experimental
BION Therapy Group
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Device: BION
30 patients operated will be randomized into 2 equal groups, a BION Therapy Group ("Rx group") and a Control Group ("Control group").
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Control Group: Placebo Comparator
control group
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Device: BION
30 patients operated will be randomized into 2 equal groups, a BION Therapy Group ("Rx group") and a Control Group ("Control group").
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Subject has any condition associated with a wound healing abnormality (e.g.: connective tissue disorder, immune disorder, diabetes, clinical obesity).
IDE application: BION Active Seating for Pressure Ulcer Prevention Page 65
United States, California | |
Rancho Los Amigos National Rehabilitation Center | |
Downey, California, United States, 90242 |
Principal Investigator: | Lucinda Baker, Ph.D. | University of Southern California |
Responsible Party: | Alfred E. Mann Institute ( Gerald Loeb, MD ) |
Study ID Numbers: | BT8 |
Study First Received: | February 25, 2008 |
Last Updated: | May 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00628602 |
Health Authority: | United States: Food and Drug Administration |
Neuromuscular stimulator Pressure ulcer prevention |
Skin Diseases Ulcer Skin Ulcer Pressure Ulcer |
Pathologic Processes |