NCT00628602

BION Active Seating for Pressure Ulcer Prevention

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pressure Ulcer

Interventions

Type	Name	Description
DEVICE	BION	30 patients operated will be randomized into 2 equal groups, a BION Therapy Group ("Rx group") and a Control Group ("Control group").

Timeline

• Start date: 2007-11-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2008-03-05
• Last updated: 2015-06-03

Locations

1 site across 1 country: United States